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
Spyre Therapeutics, Inc.
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening * Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis) * Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2 Exclusion Criteria: * Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined * Confirmed or suspected fulminant colitis, tox…
Interventions
- DrugSPY001
Experimental
- DrugSPY002
Experimental
- DrugSPY003
Experimental
- OtherPlacebo
Placebo
Locations (191)
- Site 024Canoga Park, California
- Site 023La Jolla, California
- Site 012Lancaster, California
- Site 033Colorado Springs, Colorado
- Site 007Kissimmee, Florida
- 029Miami, Florida