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
Published: 11/04/2025
General Information:
This platform study will evaluate the efficacy and safety of investigational treatments, including 3 investigational monotherapies and 3 combinations, for adults with moderately to severely active UC.
Eligibility:
Inclusion Criteria:
- Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during screening
- 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
Study Details:
Study description/explanation of participation:
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.
Description of treatment or intervention (mechanism of action):
SPY001 is a humanized monoclonal antibody that specifically targets the α4β7 integrin.
SPY002 is a fully human IgG1 monoclonal antibody that binds to the cytokine TLIA.
SPY003 is a recombinant humanized IgG1 monoclonal antibody that specifically targets IL-23p19.
Possible risks and side effects:
The study drugs are investigational treatments and have not been proven safe or effective for any use. Based on Phase I studies, non-clinical studies, and information available from products with similar mechanisms of action, there is a potential risk for hypersensitivity, immunogenicity, infection and liver abnormalities. Risks and side effects related to each intervention will be discussed in more detail with the clinical investigator if you decide that you would like to participate.