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A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2022

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At a glance

  • Drugs Larazotide (Primary)
  • Indications Coeliac disease
  • Focus Registrational; Therapeutic Use
  • Acronyms CeDLara
  • Sponsors 9 Meters Biopharma [CEASED]; Innovate Biopharmaceuticals

    • Most Recent Events

    • 22 Jul 2022 Status changed from recruiting to discontinued.
    • 21 Jun 2022 According to a 9 Meters Biopharma media release, this study follows a Phase 2 clinical trial in 342 adult patients with celiac disease who had been on a gluten-free diet for at least 12 months, which concluded that larazotide 0.5 mg significantly reduced symptoms of celiac disease.
    • 21 Jun 2022 According to a 9 Meters Biopharma media release, interim analysis indicated that an additional number of patients was required to determine a significant outcome between placebo and larazotide. This number was decided to be too large to support trial continuation.

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