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A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO)

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ClinicalTrials.gov Identifier: NCT05528510
Recruitment Status : Active, not recruiting
First Posted : September 6, 2022
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Guselkumab Dose 3 Other: Placebo Phase 3

Detailed Description:
UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The primary hypothesis of this study is that guselkumab SC induction is superior to placebo SC in achieving clinical remission at Week 12 among participants with moderately to severely active UC. This study consists of screening period, main treatment period, extension treatment period and safety follow-up period. Efficacy and safety assessments including adverse events, clinical laboratory tests, vital signs, and physical examinations will be performed according to the schedule of activities. The overall study duration will be up to 112 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : September 13, 2022
Actual Primary Completion Date : April 2, 2024
Estimated Study Completion Date : October 10, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Guselkumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
 Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered as SC injection.

Drug: Guselkumab Dose 2
Guselkumab (Dose 2) will be administered as SC injection.
Experimental: Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
 Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered as SC injection.

Drug: Guselkumab Dose 3
Guselkumab (Dose 3) will be administered as SC injection.
Placebo Comparator: Group 3: Placebo
Participants will receive matching placebo SC injection.
 Other: Placebo
Placebo will be administered as SC injection.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Remission [ Time Frame: Week 12 ]
    Clinical remission per modified Mayo score.


Secondary Outcome Measures :
  1. Symptomatic Remission [ Time Frame: Weeks 12 and 24 ]
    Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen).

  2. Endoscopic Improvement [ Time Frame: Weeks 12 and 24 ]
    Endoscopic improvement per Mayo endoscopy subscore.

  3. Clinical Response [ Time Frame: Weeks 12 and 24 ]
    Clinical response per modified Mayo score.

  4. Clinical Remission [ Time Frame: Week 24 ]
    Clinical remission per modified Mayo score.

  5. Histologic-Endoscopic Mucosal Improvement [ Time Frame: Week 12 ]
    Histologic-endoscopic mucosal improvement is defined as a combination of histologic improvement according to the Geboes grading system and endoscopic improvement (Mayo endoscopy subscore of 0 or 1 without friability).

  6. Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention [ Time Frame: Up to Week 112 ]
    Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


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

Inclusion Criteria:

  • Signed informed consent form
  • 18 years of age or older
  • Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
  • Moderately to severely active UC as per the modified Mayo score
  • Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
  • Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
  • Receiving prohibited medications and treatments
  • UC limited to the rectum only
  • Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05528510


Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05528510    
Other Study ID Numbers: CR109228
2022-000365-41 ( EudraCT Number )
CNTO1959UCO3004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 6, 2022    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Guselkumab
Colitis, Ulcerative
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs