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A Phase III Pivotal randomized, double-blind, placebo-controlled, multicenter Trial of NB-1001 in Patients with Short Bowel Syndrome

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Trial Profile

A Phase III Pivotal randomized, double-blind, placebo-controlled, multicenter Trial of NB-1001 in Patients with Short Bowel Syndrome

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2023

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At a glance

  • Drugs Vurolenatide (Primary)
  • Indications Short bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms VIBRANT 2
  • Sponsors 9 Meters Biopharma [CEASED]

Most Recent Events

  • 28 Mar 2023 According to a 9 Meters Biopharma media release, clarifying comments from the FDA provide additional clarification and direction on specific elements of the study protocol and design. Based on the comments received, the Company will align with the recommendations provided, including the use of a continuous variable endpoint and a 24-week study duration for both subgroups of patients in the trial. Approximately 120 patients will be enrolled in the study.
  • 22 Feb 2023 According to a 9 Meters Biopharma media release, the company announced the design of this trial following successful End-of-Phase 2 meeting and incorporates input received from the U.S. Food and Drug Administration (FDA).
  • 22 Feb 2023 According to a 9 Meters Biopharma media release, several key features have been incorporated that we believe will optimize the ability to enroll the study, including utilizing a clinical research organization (CRO) with specific experience executing late-stage clinical studies in SBS; securing up to 50 clinical study sites globally; and giving investigators the ability to enroll all SBS patients, regardless of PS status.

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