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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Jul 2025

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At a glance

  • Drugs SPY 001 (Primary) ; SPY 001 (Primary)
  • Indications Ulcerative colitis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms SKYLINE-UC

Most Recent Events

  • 26 Jun 2025 The protocol has been amended to include an addition in the treatment arm, a change in allocation as randomized allocation, a change in the interventional study model as parallel assignment, and an addition in the safety endpoint.
  • 26 Jun 2025 Planned number of patients changed from 35 to 645.
  • 26 Jun 2025 Planned End Date changed from 1 Jun 2027 to 1 Mar 2028.

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