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Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)

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Trial Profile

Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Jul 2024

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At a glance

  • Drugs Lusvertikimab (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Acronyms CoTikiS
  • Sponsors OSE Immunotherapeutics

    • Most Recent Events

    • 24 Jul 2024 Primary endpoint (Mean change from baseline in the modified Mayo Score at Week 10 exploring the clinical symptoms (stool frequency and rectal bleeding sub-scores) additionally to the endoscopic sub-score) has been met.
    • 24 Jul 2024 According to an OSE Immunotherapeutics media release, company reported first positive results from this trial and trial met its primary end point.
    • 20 Jun 2024 This trial has been completed in Belgium, according to European Clinical Trials Database record.
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