Clinical Trial

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Study acronym: SKYLINE-UC
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 12 changes
notable Trial sites expanded: 253 -> 259 locations 2026-07-29
notable Trial sites expanded: 243 -> 253 locations 2026-07-17
notable Primary completion pushed: 2026-06 -> 2027-06 2026-07-17
notable Trial sites expanded: 234 -> 243 locations 2026-06-30
notable Trial sites expanded: 223 -> 234 locations 2026-06-23
notable Trial sites expanded: 206 -> 223 locations 2026-06-09
notable Trial sites expanded: 191 -> 206 locations 2026-05-20
notable Trial sites expanded: 175 -> 191 locations 2026-05-06
notable Trial sites expanded: 162 -> 175 locations 2026-04-25
notable Trial sites expanded: 148 -> 162 locations 2026-04-22
notable Trial sites expanded: 143 -> 148 locations 2026-04-15
notable Trial sites expanded: 129 -> 143 locations 2026-04-07
Trial Details
NCT Number NCT07012395
Lead Sponsor Spyre Therapeutics, Inc.
Conditions Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
Enrollment 645 participants
Start Date 2025-05-27
Primary Completion 2027-06 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-28