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

Condition studied

Moderately to Severely Active Ulcerative Colitis

Investigational medicinal product(s)

Every trial of SPYPBO-101, SPY001, SPY002 and SPY003 across our registers →

Eligibility

Primary endpoint

Part A: Change in RHI from baseline at Week 12., Part B: Clinical remission at Week 12.

Endpoint detail

Part A: 1. Clinical remission at Week 12., Part A: 2. Endoscopic improvement at Week 12., Part A: 3. Change in modified Mayo score from baseline at Week 12., Part A: 4. Study drug concentration through Week 12., Part A: 5. Percentage of participants with ADAs to study drug(s) through Week 12., Part B: 1. Endoscopic improvement at Week 12., Part B: 2. Clinical response at Week 12., Part B: 3. Histologic improvement at Week 12., Part B: 4. HEMI at Week 12., Part B: 5. Clinical remission at Week 48., Part B: 6. Study drug concentration through Week 12., Part B: 7. Percentage of participants with ADA to study drug(s) through Week 12.