2023-504719-34-00
Active, not recruiting
Phase 3
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
Janssen - Cilag International31 sites in 9 countries143 target enrollmentStarted: June 18, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 143
- Locations
- 31
- Primary Endpoint
- Clinical remission (at week 12)
Overview
Brief Summary
To evaluate the efficacy, including clinical remission, of guselkumab SC induction compared to placebo in participants with moderately to severely active UC
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
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, TNFα antagonists, vedolizumab, ozanimod, or approved JAK inhibitors).
Exclusion Criteria
- •1.Has severe extensive colitis as defined in the protocol
- •2.Extent of inflammatory disease limited to the rectum
- •3.Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)
- •4.Has a history of, or ongoing, chronic or recurrent infectious disease
- •5.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 weeks prior to first dose of study intervention)
Outcomes
Primary Outcomes
Clinical remission (at week 12)
Clinical remission (at week 12)
Secondary Outcomes
No secondary outcomes reported
Investigators
CTIS Point of Contact
Scientific
Janssen - Cilag International
Study Sites (31)
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