Trials / Active Not Recruiting
Active Not RecruitingNCT04033445
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,064 (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 and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Participants will receive matching placebo IV or SC. |
| DRUG | Guselkumab | Participants will receive guselkumab IV or SC. |
Timeline
- Start date
- 2019-09-26
- Primary completion
- 2023-09-19
- Completion
- 2027-09-29
- First posted
- 2019-07-26
- Last updated
- 2026-04-13
- Results posted
- 2024-11-18
Locations
392 sites across 34 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04033445. Inclusion in this directory is not an endorsement.