Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Part of paid clinical trials in Lancaster, California.
- Sponsor
- Spyre Therapeutics, Inc.
- Study ID
- NCT07652294
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Colitis
- Colitis, Ulcerative
- Inflammatory Bowel Diseases
- Ulcerative Colitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SPY001 — DRUGExperimental
- SPY002 — DRUGExperimental
- SPY003 — DRUGExperimental
Study Details
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Key Dates
- First listed
- Jun 17, 2026
- Start date
- Jun 8, 2026
- Status verified
- Sep 2026
- Primary completion
- Mar 2, 2029
- Completion
- Jan 3, 2030
Study Design
- Enrollment
- 645 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SPY001 Dosing Regimen 1Participants will receive SPY001
- Experimental: SPY002 Dosing Regimen 1Participants will receive SPY002
- Experimental: SPY003 Dosing Regimen 1Participants will receive SPY003
- Experimental: SPY001 Dosing Regimen 2Participants will receive SPY001
- Experimental: SPY002 Dosing Regimen 2Participants will receive SPY002
- Experimental: SPY003 Dosing Regimen 2Participants will receive SPY003
- Experimental: SPY001 & SPY002Participants will receive SPY001 and SPY002
- Experimental: SPY001 & SPY003Participants will receive SPY001 and SPY003
- Experimental: SPY002 & SPY003Participants will receive SPY002 and SPY003
- Experimental: SPY002 Dosing Regimen 3Participants will receive SPY002
Primary Outcome Measure
Percentage of participants who experienced an adverse event [ Time Frame: Week 96 ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site 012 | Lancaster | California | 93534 | - |
| Site 035 | Marrero | Louisiana | 70072 | - |
| Study Site 002 | San Antonio | Texas | 78229 | - |
| Site 019 | Tacoma | Washington | 98405 | - |
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