A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Phase 1

• Conditions: Moderately to Severely Active Ulcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-000365-41-PL
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-18
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

•Documented diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
•Moderately to severely active UC as assessed by the modified mayo score
•Demonstraed inadequate response to or intolerance of conventional (ie, 6-MP, AZA, or corticosteroids) or advanced therapy (ADT; ie, TNFa antagonists, vedolizumab, ozanimod, or approved JAK inhibitors).

For an overview of all the inclusion criteria please refer to protocol section 5.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 379
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Has severe extensive colitis as defined in the protocol
• Extent of inflammatory disease limited to the rectum
•Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)
•Has a history of, or ongoing, chronic or recurrent infectious disease
•Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or
cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

For an overview of all the exclusion criteria please refer to protocol section 5.2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy, including clinical remission, of guselkumab SC induction compared to placebo in participants with moderately to severely active UC<br>;Secondary Objective: 1- To further evaluate the efficacy of guselkumab SC induction compared to placebo across a range of outcome measures<br>2- To evaluate the safety of guselkumab SC induction compared to placebo <br><br>;Primary end point(s): - Clinical remission<br>;Timepoint(s) of evaluation of this end point: - At Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1 Symptomatic remission <br>2 Endoscopic improvement<br>3 Clinical response <br>4 Clinical remission <br>5 Symptomatic remission <br>6 Endoscopic improvement <br>7 Clinical response <br>8 Histologic-endoscopic mucosal improvement <br><br><br><br><br>;Timepoint(s) of evaluation of this end point: 1 At Week 12<br>2 At Week 12 <br>3 At Week 12<br>4 At Week 24<br>5 At week 24<br>6 At Week 24 <br>7 At Week 24 <br>8 At Week 12