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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT07012395

Run by

Spyre Therapeutics, Inc.

People needed

645

Starts

2025-05-27

Expected to finish

2028-03-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site 023 — La Jolla, California, United States (enrolling)
• Site 012 — Lancaster, California, United States (enrolling)
• Site 033 — Colorado Springs, Colorado, United States (enrolling)
• Site 007 — Kissimmee, Florida, United States (enrolling)
• 029 — Miami, Florida, United States (enrolling)
• Site 038 — Chicago, Illinois, United States (enrolling)
• Site 006 — Kansas City, Kansas, United States (enrolling)
• Site 030 — Louisville, Kentucky, United States (enrolling)
• Site 035 — Marrero, Louisiana, United States (enrolling)
• Site 011 — Glen Burnie, Maryland, United States (enrolling)
• Site 003 — Boston, Massachusetts, United States (enrolling)
• Site 028 — Rochester, Minnesota, United States (enrolling)
• Site 037 — New York, New York, United States (enrolling)
• 040 — Chapel Hill, North Carolina, United States (enrolling)
• Site 041 — Durham, North Carolina, United States (enrolling)
• Site 016 — Winston-Salem, North Carolina, United States (enrolling)
• Site 025 — Providence, Rhode Island, United States (enrolling)
• Site 017 — Kingsport, Tennessee, United States (enrolling)
• Site 013 — Cedar Park, Texas, United States (enrolling)
• Site 005 — Garland, Texas, United States (enrolling)
• Site 002 — San Antonio, Texas, United States (enrolling)
• Site 008 — Southlake, Texas, United States (enrolling)
• Site 009 — Webster, Texas, United States (enrolling)
• Site 004 — Seattle, Washington, United States (enrolling)
• Site 024 — Canoga Park, California, United States (enrolling)

Full record on ClinicalTrials.gov

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