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Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

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Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Feb 2025

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At a glance

  • Drugs Ordesekimab (Primary)
  • Indications Coeliac disease
  • Focus Therapeutic Use
  • Acronyms PROACTIVE
  • Sponsors Provention Bio

    • Most Recent Events

    • 04 Feb 2025 Primary endpoint (Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire) has not been met, according to an Amgen media release.
    • 04 Sep 2024 Status changed from active, no longer recruiting to completed.
    • 20 Jul 2024 This trial has been completed in Netherlands, according to European Clinical Trials Database record.

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