Trials / Active Not Recruiting
Active Not RecruitingNCT05528510
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Guselkumab Dose 3 | Guselkumab (Dose 3) will be administered as SC injection. |
| OTHER | Placebo | Placebo will be administered as SC injection. |
Timeline
- Start date
- 2022-09-13
- Primary completion
- 2024-04-02
- Completion
- 2028-10-06
- First posted
- 2022-09-06
- Last updated
- 2026-04-13
- Results posted
- 2025-12-09
Locations
236 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, India, Israel, Japan, Jordan, Malaysia, Mexico, New Zealand, Poland, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05528510. Inclusion in this directory is not an endorsement.