A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)

• ClinicalTrials.gov Identifier: NCT02407236
• Recruitment Status: Completed
• First Posted: April 2, 2015
• Results First Posted: December 23, 2019
• Last Update Posted: January 5, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Condition or disease	Intervention/treatment	Phase
Colitis, Ulcerative; Inflammatory Bowel Diseases	Drug: Placebo IV; Drug: Placebo SC; Drug: Ustekinumab IV; Drug: Ustekinumab SC	Phase 3

Detailed Description:

This is a Phase 3, randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), multi-center (more than one clinical site will work on a medical research study), protocol of ustekinumab. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8 weeks duration for each participant. Participant with clinical response in the Induction study will be eligible for the Maintenance study. The Maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the Induction study. Clinical remission among ustekinumab Induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 961 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
• Actual Study Start Date: July 10, 2015
• Actual Primary Completion Date: August 10, 2018
• Actual Study Completion Date: November 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Induction Study - Placebo Intravenous (IV); Participants will be randomized to receive single dose of placebo as Intravenous (IV: into the vein) infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study, but will not be randomized.	Drug: Placebo IV; Placebo will be administered as intravenous infusion.
Experimental: Induction Study - Ustekinumab 130 milligram (mg) IV; Participants will be randomized to receive single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.	Drug: Ustekinumab IV; Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Experimental: Induction Study - Ustekinumab 6 mg/kg IV; Participants will be randomized to receive ustekinumab approximating 6 mg/kg of body weight, as intravenous infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.	Drug: Ustekinumab IV; Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Induction Study- Placebo- Nonresponsders at Week 8; Participants without clinical response to placebo at Week 8 will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo (to maintain the blind). Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized.	Drug: Placebo SC; Placebo will be administered Subcutaneously.; Drug: Ustekinumab IV; Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Induction study-Ustekinumab Nonresponders at Week 8; Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) at Week 8 will receive a single dose of ustekinumab 90 mg subcutaneously along with matching placebo intravenously (to maintain the blind). Participants in clinical response at Week 16 (that is, delayed responders) will be eligible to enter Maintenance study, but will not be randomized.	Drug: Placebo IV; Placebo will be administered as intravenous infusion.; Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.
Placebo Comparator: Maintenance Study - Placebo Subcutaneous (SC); Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	Drug: Placebo SC; Placebo will be administered Subcutaneously.
Experimental: Maintenance Study - Ustekinumab 90mg SC every 12 weeks; Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 12 weeks, beginning Week 0 of Maintenance study through Week 44.	Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.
Experimental: Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w); Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44.	Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.
Maintenance Study - Placebo IV - Responder - Placebo SC; Participants in clinical response to Induction treatment with IV Placebo will receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.	Drug: Placebo SC; Placebo will be administered Subcutaneously.
Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w; Participants without clinical response to induction treatment ustekinumab (130 mg or 6 mg/kg [IV]) at Week 8 but in clinical response at Week 16 after receiving Induction Ustekinumab at week 8 (delayed responders) will receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.	Drug: Ustekinumab SC; Ustekinumab will be administered as subcutaneously.

Outcome Measures

Primary Outcome Measures :

1. Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition) [ Time Frame: Week 8 ]
   As per global definition, clinical remission is defined as a Mayo score less than or equal to (<=)2 points, with no individual subscore greater than (>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding [RB], endoscopy findings, and physician's global assessment [PGA]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
2. Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition) [ Time Frame: Week 8 ]
   As per US definition, clinical remission was defined as absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
3. Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition) [ Time Frame: Week 44 ]
   As per global definition, clinical remission was defined as a Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
4. Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition) [ Time Frame: Week 44 ]
   Per US definition, clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Secondary Outcome Measures :

1. Induction Study: Number of Participants With Endoscopic Healing at Week 8 [ Time Frame: Week 8 ]
   Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
2. Induction Study: Number of Participants With Clinical Response at Week 8 [ Time Frame: Week 8 ]
   Clinical response was defined as a decrease from induction baseline in the Mayo score by >=30 percent (%) and >= 3 points, with either a decrease from baseline in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
3. Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 [ Time Frame: Baseline and Week 8 ]
   The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of event onward or participants who had missing IBDQ score at Week 8 had their last value carried forward.
4. Maintenance Study: Number of Participants With Clinical Response up to Week 44 [ Time Frame: Up to Week 44 ]
   Clinical response: decrease from induction baseline in Mayo score by >= 30% and >= 3 points, with either decrease from induction baseline in rectal bleeding subscore >=1 or rectal bleeding subscore of 0 or 1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5= mild; 6 to 10= moderate; 11 to 12= severe; higher scores indicate worsening of disease. Participants who lost clinical response at any time before Week 44, had prohibited change in UC medication, ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
5. Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 [ Time Frame: Week 44 ]
   Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It was defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had prohibited change in UC medication, an ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
6. Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition) [ Time Frame: Week 44 ]
   Per global definition, clinical remission was defined as Mayo score <=2 points, with no individual subscore >1. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to have achieved OM of clinical remission and not receiving corticosteroids at Week 44. Participants who had missing value in corticosteroid use at Week 44 had their last value carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
7. Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition) [ Time Frame: Week 44 ]
   US definition of clinical remission: absolute stool number <=3, rectal bleeding subscore 0 (no blood seen), Mayo endoscopy subscore of 0(normal or inactive disease)/ 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in corticosteroid-free clinical remission at Week 44. Participants with missing value in corticosteroid use at Week 44 had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.
8. Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per Global Definition) [ Time Frame: Up to Week 44 ]
   Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Participants who were not in clinical remission at any time points when endoscopic scores were collected before Week 44 were considered not to be in clinical remission up to Week 44. Endoscopy subscore as assessed during central review of video of endoscopy was used.
9. Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per US Definition) [ Time Frame: Up to Week 44 ]
   US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in clinical remission. Participants not in clinical remission at any time point when endoscopic scores collected before Week 44 considered not in clinical remission up to Week 44. Endoscopy subscore assessed during central review of video of endoscopy was used.
10. Induction Study - Number of Participants With Mucosal Healing at Week 8 [ Time Frame: Week 8 ]
    Mucosal healing is defined as having both endoscopic healing (EH) and histologic healing (HH). Endoscopic healing: an endoscopy subscore of 0 (normal or inactive disease) or 1 mild disease ([erythema, decreased vascular pattern, mild friability]). Histologic healing: neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions or ulcerations or granulation tissue. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or had missing endoscopy score/ were missing any component of histologic healing (that is assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 8 or who had unevaluable biopsy (that is biopsy collected, but could not be assessed due to sample preparation or technical errors) at Week 8 but who did not achieve endoscopic healing, were considered not to have mucosal healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
11. Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition) [ Time Frame: Week 8 ]
    As per global definition, clinical remission is defined as Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had missing rectal bleeding subscores at Week 8 were considered not to be in clinical remission with a rectal bleeding subscore of 0. Endoscopy subscore as assessed during central review of video of endoscopy was used.
12. Induction Study - Number of Participants in Symptomatic Remission at Week 8 [ Time Frame: Week 8 ]
    Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 and/or both stool frequency and rectal bleeding subscores missing at Week 8 were considered not to be in symptomatic remission.
13. Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8 [ Time Frame: Week 8 ]
    Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have normal or inactive mucosal disease. Endoscopy subscore as assessed during central review of video of endoscopy was used.
14. Induction Study - Change From Baseline in Mayo Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline Mayo score carried forward to Week 8 or who had all 4 Mayo subscores missing at Week 8 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
15. Induction Study - Change From Baseline in Partial Mayo Score Through Week 8 [ Time Frame: Baseline through Week 8 ]
    The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants with the partial Mayo score missing at a timepoint had their last available individual partial Mayo subscore carried forward to that timepoint.
16. Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 [ Time Frame: Up to Week 8 ]
    The stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo stool frequency subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
17. Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 [ Time Frame: Up to Week 8 ]
    The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 = blood alone passed. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo rectal bleeding subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
18. Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8 [ Time Frame: Week 8 ]
    The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo endoscopy subscore at Week 8 had the last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
19. Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 [ Time Frame: Up to Week 8 ]
    The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo physician's global assessment subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
20. Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition) [ Time Frame: Week 8 ]
    Global definition of clinical remission: Mayo score<=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score = sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores indicate worsening of disease. BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response or were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.
21. Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition) [ Time Frame: Week 8 ]
    US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores rated 0 (normal) to 3 (severe). BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, Mayo endoscopy subscore) at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review used endoscopy video.
22. Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status [ Time Frame: Week 8 ]
    Number of participants with endoscopic healing at week 8 by BF status were reported. Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: Participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response/ were intolerant of medication. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
23. Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status [ Time Frame: Week 8 ]
    Clinical response: decrease from induction baseline in Mayo score by >=30% and >= 3 points, with either decrease from baseline in rectal bleeding subscore >=1/ rectal bleeding subscore= 0/1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores =worsening of disease. BF: participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
24. Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific) [ Time Frame: Week 8 ]
    Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
25. Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific) [ Time Frame: Week 8 ]
    Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
26. Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8 [ Time Frame: Baseline through Week 8 ]
    Change from baseline in CRP concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.
27. Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline [ Time Frame: Up to Week 8 ]
    Number of participants with normalized CRP (<=3 mg/L) up to Week 8 among participants with abnormal CRP (>3 mg/L) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing CRP value at the designated analysis timepoint were considered not to have normalized CRP.
28. Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8 [ Time Frame: Baseline through Week 8 ]
    Change from baseline in fecal lactoferrin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.
29. Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline [ Time Frame: Up to Week 8 ]
    Number of participants with normalized fecal lactoferrin (<=7.24 mcg/g) up to Week 8 among participants with abnormal fecal lactoferrin (> 7.24 mcg/g) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal lactoferrin value at the designated analysis timepoint were considered not to have normalized fecal lactoferrin.
30. Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8 [ Time Frame: Baseline through Week 8 ]
    Change from baseline in fecal calprotectin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.
31. Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline [ Time Frame: Up to Week 8 ]
    Number of participants with normalized fecal calprotectin (<=250 milligram per kilogram [mg/kg) up to Week 8 among participants with abnormal fecal calprotectin (>250 mg/kg) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal calprotectin value at the designated analysis timepoint were considered not to have normalized fecal calprotectin.
32. Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing IBDQ score at either baseline or Week 8 were considered not to have achieved a greater than 20-point improvement.
33. Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8 [ Time Frame: Baseline and Week 8 ]
    The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward and participants who had missing IBDQ dimension score at designated analysis timepoint had their last value carried forward.
34. Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8 [ Time Frame: Baseline and Week 8 ]
    SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, physical component summary (PCS: calculated from subscales physical functioning, role-physical, bodily pain, and general health) and mental component summary (MCS: calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing component summary score at Week 8 had their last value carried forward.
35. Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 [ Time Frame: Baseline and Week 8 ]
    SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing individual scale at a designated analysis timepoint had their last value carried forward.
36. Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.
37. Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.
38. Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.
39. Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44 [ Time Frame: Baseline and Week 44 ]
    The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy , or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to Week 44 had their Week 0 value of the induction study carried forward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
40. Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44 [ Time Frame: Induction Baseline and Week 44 ]
    The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total Mayo score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
41. Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 [ Time Frame: Up to Week 44 ]
    Stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.
42. Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 [ Time Frame: Up to Week 44 ]
    The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool <half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had last available value for that subscore carried forward.
43. Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44 [ Time Frame: Week 44 ]
    The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 =normal/ inactive disease, 1 =mild disease (erythema, decreased vascular pattern, mild friability), 2 =moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 =severe disease (spontaneous bleeding, ulceration). Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
44. Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 [ Time Frame: Up to Week 44 ]
    The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.
45. Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 [ Time Frame: Baseline through Week 44 ]
    The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores), rated as 0 (normal) to 3 (severe). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.
46. Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 [ Time Frame: Baseline through Week 44 ]
    The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.
47. Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44 [ Time Frame: Week 44 ]
    Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
48. Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44 [ Time Frame: Week 44 ]
    Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
49. Maintenance Study: Number of Participants in Symptomatic Remission at Week 44 [ Time Frame: Week 44 ]
    Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 were considered not to be in symptomatic remission from the time of the event onward. Participants who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. Endoscopy subscore as assessed during central review of video of endoscopy was used.
50. Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition) [ Time Frame: Week 44 ]
    Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.
51. Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition) [ Time Frame: Week 44 ]
    US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 0(normal/ inactive disease) or 1(mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0(normal) to 3(severe). BF: participants received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect /due to AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components (absolute stool number, rectal bleeding and endoscopy) at Week 44 were not in clinical remission. Endoscopy subscore assessed during central review used video of endoscopy.
52. Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status [ Time Frame: Up to Week 44 ]
    Clinical response: decrease from IS baseline in Mayo score by >=30% and >=3 points, with either decrease from baseline in RB subscore >=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 0(normal) to 3(severe). Total score=sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsen UC before Week 44, had all 4 Mayo subscores miss at Week44/ lost clinical response at any time before Week44 were not in clinical response upto Week44. Endoscopy subscore assessed during central review used endoscopy video.
53. Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status [ Time Frame: Week 44 ]
    Number of participants with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy, or used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
54. Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline [ Time Frame: Week 44 ]
    Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
55. Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44 [ Time Frame: Week 44 ]
    Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
56. Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per Global Definition) [ Time Frame: Week 44 ]
    Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/AE of worsening of UC before Week 44 considered not to achieved OM of clinical remission and not receiving concomitant corticosteroids (corticosteroid-free clinical remission). Participants with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Participants missing value in corticosteroid use had their last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.
57. Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition) [ Time Frame: Week 44 ]
    US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and endoscopy subscore) at Week 44 were considered not in clinical remission. Participants with missing value in corticosteroid use had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.
58. MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline [ Time Frame: Baseline Through Week 44 ]
    The change from maintenance baseline in average daily prednisone-equivalent (P.Eq) corticosteroid dose through Week 44 among the participants receiving concomitant corticosteroids other than budesonide and beclomethasone dipropionate at maintenance baseline was reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing value in corticosteroid use at a timepoint had their last available value carried forward to that timepoint.
59. Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline [ Time Frame: Week 44 ]
    Number of participants not receiving concomitant corticosteroids at Week 44 among participants who received concomitant corticosteroids at maintenance Baseline were reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 considered to be receiving concomitant corticosteroids at Week 44. Participants who had a missing value in corticosteroid use at Week 44 had their last value carried forward.
60. Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline [ Time Frame: Up to Week 44 ]
    IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as:10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had missing IBDQ score were considered not to have maintained improvement in IBDQ.
61. Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44 [ Time Frame: Baseline, Week 20, and 44 ]
    IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing IBDQ score at a timepoint had their last value carried forward.
62. Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 [ Time Frame: Baseline, Week 20, and 44 ]
    The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and participants who had missing IBDQ dimension score at a timepoint had their last available value carried forward.
63. Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44 [ Time Frame: Baseline, Weeks 20, and 44 ]
    SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and MCS (calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had Week 0 value of IS carried forward from time of event onward and participants with missing component summary score at timepoint had last available value carried forward.
64. Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 [ Time Frame: Baseline, Weeks 20, and 44 ]
    SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and participants with missing individual scale score at timepoint had last available value carried forward.
65. Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44 [ Time Frame: Baseline, Weeks 20, and 44 ]
    EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing individual scale score at a timepoint had their last available value carried forward.
66. Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44 [ Time Frame: Baseline, Weeks 20 and 44 ]
    The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing VAS score at a timepoint had their last available value carried forward.
67. Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 [ Time Frame: Baseline, Weeks 20, and 44 ]
    EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing individual scale score at timepoint had their last available value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.
68. Maintenance Study: Number of Participants With Mucosal Healing at Week 44 [ Time Frame: Week 44 ]
    Mucosal healing included EH and HH. EH: endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). HH: neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions/ ulcerations/ granulation tissue. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44/ missing endoscopy score/ missing any component of histologic healing (i.e. assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 44 and had unevaluable biopsy (biopsy collected but could not assessed due to sample preparation/ technical errors) at Week 44, but who did not achieve endoscopic healing, considered not to have mucosal healing. Endoscopy subscore assessed during central review used endoscopy video.
69. Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44 [ Time Frame: Baseline, Weeks 8, 24, and 44 ]
    Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.
70. Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44 [ Time Frame: Baseline, Weeks 8, 24, and 44 ]
    Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.
71. Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44 [ Time Frame: Baseline, Weeks 8, 24, and 44 ]
    Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
• Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy
• Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
• Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks

Exclusion Criteria:

• Has severe extensive colitis and is at imminent risk of colectomy
• Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon
• Presence of a stoma or history of a fistula
• Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
• Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States

United States, California

La Mirada, California, United States

Los Angeles, California, United States

Newport Beach, California, United States

Torrance, California, United States

Vallejo, California, United States

United States, Colorado

Lone Tree, Colorado, United States

United States, Connecticut

Farmington, Connecticut, United States

United States, District of Columbia

Washington, District of Columbia, United States

United States, Florida

Gainesville, Florida, United States

Largo, Florida, United States

Miami, Florida, United States

Port Orange, Florida, United States

Tampa, Florida, United States

Winter Park, Florida, United States

Zephyrhills, Florida, United States

United States, Georgia

Atlanta, Georgia, United States

Decatur, Georgia, United States

Macon, Georgia, United States

Suwanee, Georgia, United States

United States, Idaho

Idaho Falls, Idaho, United States

United States, Illinois

Chicago, Illinois, United States

Evanston, Illinois, United States

Urbana, Illinois, United States

United States, Indiana

Indianapolis, Indiana, United States

United States, Kansas

Pratt, Kansas, United States

United States, Kentucky

Crestview Hills, Kentucky, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

United States, Louisiana

Houma, Louisiana, United States

Shreveport, Louisiana, United States

United States, Maryland

Columbia, Maryland, United States

United States, Massachusetts

Boston, Massachusetts, United States

United States, Michigan

Ann Arbor, Michigan, United States

Chesterfield, Michigan, United States

Troy, Michigan, United States

Ypsilanti, Michigan, United States

United States, Minnesota

Rochester, Minnesota, United States

United States, Mississippi

Jackson, Mississippi, United States

United States, New Jersey

Marlton, New Jersey, United States

Morristown, New Jersey, United States

United States, New York

Bronx, New York, United States

Brooklyn, New York, United States

Mineola, New York, United States

New York, New York, United States

Poughkeepsie, New York, United States

Rochester, New York, United States

United States, Ohio

Cincinnati, Ohio, United States

Mentor, Ohio, United States

United States, Oregon

Portland, Oregon, United States

United States, Pennsylvania

Doylestown, Pennsylvania, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Sayre, Pennsylvania, United States

United States, Tennessee

Germantown, Tennessee, United States

Nashville, Tennessee, United States

United States, Texas

Dallas, Texas, United States

Houston, Texas, United States

Irving, Texas, United States

San Antonio, Texas, United States

Southlake, Texas, United States

Tyler, Texas, United States

United States, Utah

Salt Lake City, Utah, United States

West Jordan, Utah, United States

United States, Virginia

Chesapeake, Virginia, United States

Fairfax, Virginia, United States

Roanoke, Virginia, United States

United States, Washington

Seattle, Washington, United States

Australia

Bedford, Australia

Clayton, Australia

Concord N/a, Australia

Fitzroy, Australia

Five Dock, Australia

Garran, Australia

Heidelberg, Australia

Liverpool, Australia

Melbourne, Australia

South Brisbane, Australia

Austria

Salzburg, Austria

Wien, Austria

Belgium

Antwerpen, Belgium

Gent, Belgium

Kortrijk, Belgium

Leuven, Belgium

Liege, Belgium

Liège, Belgium

Roeselaere, Belgium

Bulgaria

Pleven, Bulgaria

Rousse, Bulgaria

Sevlievo, Bulgaria

Sofia, Bulgaria

Varna, Bulgaria

Canada, British Columbia

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Canada, Manitoba

Brandon, Manitoba, Canada

Winnipeg, Manitoba, Canada

Canada, Ontario

London, Ontario, Canada

Sudbury, Ontario, Canada

Canada, Quebec

Montreal, Quebec, Canada

Czechia

Hradec Kralove, Czechia

Plzen, Czechia

Prague 4, Czechia

Praha 5, Czechia

Praha 7, Czechia

Praha 9, Czechia

Denmark

Aarhus, Denmark

Odense, Denmark

France

Amiens, France

Bordeaux, France

Lille, France

Lyon, France

Marseille, France

Montpellier, France

Pierre-Benite, France

Reims, France

Rennes, France

Saint-Etienne, France

Toulouse, France

Germany

Berlin, Germany

Essen, Germany

Freiburg, Germany

Hannover, Germany

Kiel, Germany

Leipzig, Germany

Lüneburg, Germany

Mannheim, Germany

Minden, Germany

Münster, Germany

Hungary

Balatonfüred, Hungary

Budapest, Hungary

Békéscsaba, Hungary

Debrecen, Hungary

Miskolc, Hungary

Mosonmagyarovar, Hungary

Szekszárd, Hungary

Szombathely, Hungary

Székesfehérvár, Hungary

Vac, Hungary

Israel

Beersheba, Israel

Haifa, Israel

Holon, Israel

Jerusalem, Israel

Kfar-Saba, Israel

Nahariya, Israel

Petach Tikvah, Israel

Tel Aviv, Israel

Tel Hashomer, Israel

Japan

Ageo-shi, Japan

Asahikawa, Japan

Bunkyo-Ku, Japan

Chiba, Japan

Chikushinoshi, Japan

Fujiidera, Japan

Fukuoka-ken, Japan

Higashi-Ibaraki, Japan

Hirosaki, Japan

Hiroshima, Japan

Isesaki, Japan

Iwate, Japan

Izumo, Japan

Kagawa, Japan

Kagoshima, Japan

Kahoku, Japan

Kobe-shi, Japan

Kochi, Japan

Kurume, Japan

Kyoto, Japan

Midori-ku, Japan

Nagasaki, Japan

Nara, Japan

Nishinomiya, Japan

Oita, Japan

Osaka, Japan

Saga-ken, Japan

Saga, Japan

Saitama, Japan

Sakura, Japan

Sapporo, Japan

Sendai, Japan

Shizuoka, Japan

Sunto-gun, Japan

Takamatsu, Japan

Tokorozawa, Japan

Tokyo, Japan

Toyama, Japan

Toyota, Japan

Tsuchiura, Japan

Tsu, Japan

Wakayama, Japan

Yamanashi, Japan

Korea, Republic of

Daegu, Korea, Republic of

Guri-si, Korea, Republic of

Seoul, Korea, Republic of

Suwon-si, Korea, Republic of

Netherlands

Amsterdam, Netherlands

Maastricht, Netherlands

New Zealand

Auckland, New Zealand

Christchurch, New Zealand

Dunedin, New Zealand

Lower Hutt, New Zealand

Milford, New Zealand

Poland

Gdansk, Poland

Krakow, Poland

Lodz, Poland

Pulawy, Poland

Sopot, Poland

Szczecin, Poland

Warszawa, Poland

Wroclaw, Poland

Romania

Bucuresti, Romania

Oradea, Romania

Romania, Romania

Timisoara, Romania

Russian Federation

Irkutsk, Russian Federation

Kazan, Russian Federation

Moscow, Russian Federation

Moscva, Russian Federation

Novosibirsk, Russian Federation

Rostov-on-Don, Russian Federation

Ryazan, Russian Federation

Saint Petersburg, Russian Federation

St Petersburg, Russian Federation

St.-Petersburg, Russian Federation

Stavropol, Russian Federation

Ufa, Russian Federation

Serbia

Belgrade, Serbia

Kragujevac, Serbia

Nis, Serbia

Vojvodina, Serbia

Slovakia

Bratislava, Slovakia

Presov, Slovakia

Ukraine

Chernivtsi, Ukraine

Dnipropetrovsk, Ukraine

Ivano-Frankivsk, Ukraine

Kharkiv, Ukraine

Kiyv, Ukraine

Kyiv, Ukraine

Lviv, Ukraine

Odessa, Ukraine

Sumy, Ukraine

Uzhgorod, Ukraine

Vinnytsia, Ukraine

Zaporizhzhia, Ukraine

Zhaporozhia, Ukraine

United Kingdom

Birmingham, United Kingdom

Cambridge, United Kingdom

Coventry, United Kingdom

Doncaster, United Kingdom

Edinburgh, United Kingdom

Liverpool, United Kingdom

London, United Kingdom

Salford, United Kingdom

Southampton, United Kingdom

Sutton In Ashfield, United Kingdom

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol  [PDF] April 30, 2020

Statistical Analysis Plan  [PDF] July 25, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Danese S, Sands BE, Abreu MT, O'Brien CD, Bravata I, Nazar M, Miao Y, Wang Y, Rowbotham D, Leong RWL, Arasaradnam RP, Afif W, Marano C. Early Symptomatic Improvement After Ustekinumab Therapy in Patients With Ulcerative Colitis: 16-Week Data From the UNIFI Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2858-2867.e5. doi: 10.1016/j.cgh.2022.02.050. Epub 2022 Mar 8.

Panaccione R, Danese S, Sandborn WJ, O'Brien CD, Zhou Y, Zhang H, Adedokun OJ, Tikhonov I, Targan S, Abreu MT, Hisamatsu T, Scherl EJ, Leong RW, Rowbotham DS, Arasaradnam RP, Sands BE, Marano C. Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1658-1675. doi: 10.1111/apt.16119. Epub 2020 Oct 21. Erratum In: Aliment Pharmacol Ther. 2021 May;53(9):1057-1060. Aliment Pharmacol Ther. 2021 Nov;54(9):1221-1222.

Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum In: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

Li K, Marano C, Zhang H, Yang F, Sandborn WJ, Sands BE, Feagan BG, Rubin DT, Peyrin-Biroulet L, Friedman JR, De Hertogh G. Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis. Gastroenterology. 2020 Dec;159(6):2052-2064. doi: 10.1053/j.gastro.2020.08.037. Epub 2020 Aug 25.

Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C; UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02407236
• Other Study ID Numbers: CR106920; 2014-005606-38 ( EudraCT Number ); CNTO1275UCO3001 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: April 2, 2015
• Results First Posted: December 23, 2019
• Last Update Posted: January 5, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:

Ustekinumab; Inflammatory Bowel Diseases (IBD); Colitis, Ulcerative

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Pathologic Processes; Ustekinumab; Dermatologic Agents