Clinical Trial

Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

Study acronym: SKYLINE-LTE
Enrolling by Invitation Phase 2
View on ClinicalTrials.gov →
Summary
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Protocol Amendment History 4 changes
notable Trial sites expanded: 9 -> 15 locations 2026-08-04
notable Trial sites expanded: 6 -> 9 locations 2026-07-29
notable Trial sites expanded: 1 -> 5 locations 2026-06-30
critical Primary endpoint(s) modified 2026-06-19
Trial Details
NCT Number NCT07652294
Lead Sponsor Spyre Therapeutics, Inc.
Conditions Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
Enrollment 645 participants
Start Date 2026-06-08
Primary Completion 2029-03-02 (estimated)
Study Completion 2030-01-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-03