Trials / Recruiting
RecruitingNCT07012395
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 645 (estimated)
- Sponsor
- Spyre Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
Detailed description
This platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active UC in adults. The study will progress in two parts. Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. Part B, which will be open for enrollment after Part A, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo. Intervention arms will be added to the study over time and may complete at different times.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPY001 | Experimental |
| DRUG | SPY002 | Experimental |
| DRUG | SPY003 | Experimental |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2025-05-27
- Primary completion
- 2026-06-01
- Completion
- 2028-03-01
- First posted
- 2025-06-10
- Last updated
- 2026-04-14
Locations
148 sites across 25 countries: United States, Australia, Austria, Bosnia and Herzegovina, Bulgaria, Canada, Czechia, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Jordan, Moldova, Poland, Romania, Serbia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07012395. Inclusion in this directory is not an endorsement.