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Long-acting antibody treatments alone and in combinations for moderate to severe ulcerative colitis

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

Phase 2 Interventional Spyre Therapeutics, Inc. · NCT07012395

This tests long-acting antibody medicines, given after an IV induction and then as under-the-skin maintenance, to see if they help adults with moderate to severe ulcerative colitis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment645 (estimated)
Ages18 Years and up
SexAll
SponsorSpyre Therapeutics, Inc. Industry-sponsored
Locations191 sites (Canoga Park, California and 190 other locations)
Trial IDNCT07012395 on ClinicalTrials.gov

What this trial studies

This Phase 2, multicenter platform study enrolls adults with moderately to severely active ulcerative colitis and uses an IV induction followed by subcutaneous maintenance dosing. Part A is an open-label portion to evaluate safety and early signals of efficacy for three monotherapies. Part B is randomized and placebo-controlled and will compare three monotherapies and three combination regimens to placebo, with intervention arms added over time. Primary outcomes focus on efficacy and safety in participants meeting modified Mayo score entry criteria.

Who should consider this trial

Good fit: Adults with moderately to severely active ulcerative colitis (modified Mayo score 5–9) with disease extending at least 15 cm from the anal verge who have not failed four or more classes of advanced therapy.

Not a fit: People with Crohn's disease, fulminant colitis or other conditions likely to require surgery during induction, or those who have already failed four or more advanced therapy classes, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, these long-acting antibody regimens could reduce inflammation and symptoms and help maintain remission with less frequent dosing.

How similar studies have performed: Approved biologic antibody therapies have shown benefit in ulcerative colitis, but using multiple long-acting antibodies alone and in combinations in a platform design is relatively novel and not yet proven.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Canoga Park, California and 190 other locations

+141 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.