NCT07012395 A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
| NCT ID | NCT07012395 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Spyre Therapeutics, Inc. |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 645 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 645 participants in total. It began in 2025-05-27 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction * Failed 4 or more approved or investigational advanced therapy classes
Contact & Investigator
SKYLINE-UC Study Director
STUDY DIRECTOR
Spyre Therapeutics
Frequently Asked Questions
Who can join the NCT07012395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07012395 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07012395 currently recruiting?
Yes, NCT07012395 is actively recruiting participants. Contact the research team at info@skyline-uc.com for enrollment information.
Where is the NCT07012395 trial being conducted?
This trial is being conducted at Canoga Park, United States, La Jolla, United States, Lancaster, United States, Colorado Springs, United States and 11 additional locations.
Who is sponsoring the NCT07012395 clinical trial?
NCT07012395 is sponsored by Spyre Therapeutics, Inc.. The principal investigator is SKYLINE-UC Study Director at Spyre Therapeutics. The trial plans to enroll 645 participants.
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