A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpyre Therapeutics, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SPY001
- SPY002
- SPY003
- Placebo
Treatment groups
645 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Locations
243Argentina
Site 1025505, Lujan de CuyoMendoza Province, Argentina
Site 1032000, RosarioSant Fe, Argentina
Site 1044000, San Miguel de TucumánTucumán Province, Argentina
Australia
Site 2082139, Concord Australia
Sponsors and collaborators
Spyre Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov