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

Condition(s) studied

Investigational drug(s) / intervention(s)

SPY001: Experimental

SPY002: Experimental

SPY003: Experimental

Placebo: Placebo

Study 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

Primary outcome measure(s)

• Part A: Change in Robarts Histopathology Index (RHI) — Week 12
  Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
• Part B: Percentage of participants with clinical remission — Week 12
  Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.

Trial sites (267)

+ 227 more sites — see the full list on the official registry below.

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