Trials / Active Not Recruiting
Active Not RecruitingNCT06127043
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- AnaptysBio, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of rosnilimab in subjects with moderate to severe ulcerative colitis (UC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rosnilimab | PD-1 agonist antibody |
| DRUG | Placebo | Administered via SC |
Timeline
- Start date
- 2023-12-04
- Primary completion
- 2026-01-01
- Completion
- 2026-05-01
- First posted
- 2023-11-13
- Last updated
- 2025-10-03
Locations
100 sites across 15 countries: United States, Austria, Bulgaria, Canada, Croatia, France, Georgia, Germany, Italy, Netherlands, Poland, Romania, Serbia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06127043. Inclusion in this directory is not an endorsement.