Trials / Recruiting
RecruitingNCT06588855
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 16 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Afimkibart | Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection. |
| DRUG | Placebo | Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
Timeline
- Start date
- 2024-12-11
- Primary completion
- 2027-01-30
- Completion
- 2031-01-30
- First posted
- 2024-09-19
- Last updated
- 2026-04-02
Locations
198 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Spain, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06588855. Inclusion in this directory is not an endorsement.