A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

• ClinicalTrials.gov Identifier: NCT03398135
• Recruitment Status: Active, not recruiting
• First Posted: January 12, 2018
• Last Update Posted: October 12, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: January 8, 2018
• First Posted Date: January 12, 2018
• Last Update Posted Date: October 12, 2023
• Actual Study Start Date: August 28, 2018
• Estimated Primary Completion Date: September 25, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 11, 2023)

• Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score [ Time Frame: Week 52 ]
  Clinical remission per Adapted Mayo Score.
• Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to Week 300 ]
  An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Original Primary Outcome Measures (submitted: January 8, 2018)

Percentage of participants with clinical remission per adapted Mayo Score at Week 52 [ Time Frame: Week 52 ]

Clinical remission per adapted Mayo Score.

Current Secondary Outcome Measures (submitted: February 15, 2023)

• Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement [ Time Frame: Week 52 ]
  Endoscopic improvement per endoscopy subscore.
• Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement [ Time Frame: Week 52 ]
  Percentage of participants achieving histologic-endoscopic mucosal improvement.
• Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 52 ]
  Endoscopic remission per endoscopy subscore.
• Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days [ Time Frame: Week 52 ]
  Clinical remission per Adapted Mayo Score.
• Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 [ Time Frame: Week 52 ]
  Clinical remission per Adapted Mayo Score.
• Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency [ Time Frame: Week 52 ]
  Percentage of participants achieving no bowel urgency.
• Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain [ Time Frame: Week 52 ]
  Percentage of participants achieving no abdominal pain.
• Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission [ Time Frame: Week 52 ]
  Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.
• Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 [ Time Frame: Week 52 ]
  Endoscopic improvement per endoscopy subscore.
• Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score [ Time Frame: Week 52 ]
  Clinical response per Adapted Mayo Score.
• Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: Week 0 to Week 52 ]
  The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
• Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline (Week 0) to Week 52 ]
  The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
• Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements [ Time Frame: Week 52 ]
  Percentage of participants achieving no nocturnal bowel movements.
• Sub-Study 1: Percentage of Participants Achieving No Tenesmus [ Time Frame: Week 52 ]
  Percentage of participants achieving no tenesmus.
• Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week [ Time Frame: Baseline (Week 0) to Week 52 ]
  Change in number of fecal incontinence episodes per week.
• Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms [ Time Frame: Baseline (Week 0) to Week 52 ]
  Change in number of days per week with sleep interrupted due to UC symptoms.
• Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization [ Time Frame: Through Week 52 ]
  Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.

Original Secondary Outcome Measures (submitted: January 8, 2018)

• Percentage of participants with endoscopic improvement at Week 52 [ Time Frame: Week 52 ]
  Endoscopic improvement per endoscopy subscore.
• Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction) [ Time Frame: Week 52 ]
  Clinical remission per full Mayo Score.
• Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction). [ Time Frame: Week 52 ]
  Clinical remission per adapted Mayo Score.
• Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0 [ Time Frame: Week 52 ]
  Clinical remission per adapted Mayo Score.
• Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction) [ Time Frame: Week 52 ]
  Participants who discontinued corticosteroid use.
• Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0 [ Time Frame: Week 52 ]
  Endoscopic improvement per endoscopy subscore.
• Percentage of participants with clinical response per adapted Mayo score at Week 52 [ Time Frame: Week 52 ]
  Clinical response per adapted Mayo score.
• Percentage of participants with endoscopic remission at Week 52 [ Time Frame: Week 52 ]
  Endoscopic remission per endoscopy subscore.
• Percentage of participants with hospitalization through Week 52 [ Time Frame: 52 weeks ]
  Participants with an event that results in admission to the hospital.
• Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
  The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.
• Percentage of participants with histologic remission at Week 52 [ Time Frame: Week 52 ]
  Histologic remission per Geboes Score.
• Percentage of participants with mucosal healing at Week 52 [ Time Frame: Week 52 ]
  Mucosal healing defined as endoscopic and histologic remission.
• Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
  The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
• Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52 [ Time Frame: 52 weeks ]
  Participants who underwent surgery related to UC.
• 36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
  The SF-36 is an indicator of overall health status.
• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
  The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

Brief Summary

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Ulcerative Colitis (UC)

Intervention

• Drug: risankizumab
  subcutaneous (SC) injection
  Other Names:

  • ABBV-066
  • BI 655066
  • SKYRIZI
• Drug: placebo for risankizumab
  subcutaneous (SC) injection

Study Arms

• Placebo Comparator: Substudy 1: Double-blind Placebo
  Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
  Intervention: Drug: placebo for risankizumab
• Experimental: Substudy 1: Double-blind Risankizumab Dose 1
  Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
  Intervention: Drug: risankizumab
• Experimental: Substudy 1: Double-blind Risankizumab Dose 2
  Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
  Intervention: Drug: risankizumab
• Experimental: Substudy 2: Open-label (OL) Clinical Assessment Risankizumab
  Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
  Intervention: Drug: risankizumab
• Experimental: Substudy 2: OL Therapeutic Drug Monitoring Risankizumab
  Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
  Intervention: Drug: risankizumab
• Experimental: Substudy 3: OL Extension Risankizumab
  Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
  Intervention: Drug: risankizumab
• Experimental: OL Continuous Treatment Extension - Dose 1
  Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.
  Intervention: Drug: risankizumab
• Experimental: OL Continuous Treatment Extension - Dose 2
  Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.
  Intervention: Drug: risankizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 27, 2023): 1242
• Original Estimated Enrollment (submitted: January 8, 2018): 760
• Estimated Study Completion Date: September 25, 2028
• Estimated Primary Completion Date: September 25, 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion Criteria:

• Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
• Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
• Removed Location Countries: American Samoa, Australia, Hungary, Malaysia

Administrative Information

• NCT Number: NCT03398135
• Other Study ID Numbers: M16-066; 2016-004676-22 ( EudraCT Number ); 2023-506994-36-00 ( Other Identifier: EU CT )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: October 2023