Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
NCT07652294 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 645
Last updated 2026-08-18
Summary
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Conditions
- Ulcerative Colitis
- Inflammatory Bowel Diseases
- Colitis
- Colitis, Ulcerative
Interventions
- DRUG
-
SPY001
Experimental
- DRUG
-
SPY002
Experimental
- DRUG
-
SPY003
Experimental
Sponsors & Collaborators
-
Spyre Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
SKYLINE Study Director · Spyre Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-08
- Primary Completion
- 2029-03-02
- Completion
- 2030-01-03
- FDA Drug
- Yes
Countries
- United States
- Czechia
- Georgia
- Greece
- Poland
- Serbia
- South Korea
- Taiwan
- Ukraine
Study Locations
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