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A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis

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Trial Profile

A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Jun 2024

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At a glance

  • Drugs Bezuclastinib (Primary)
  • Indications Systemic mastocytosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SUMMIT
  • Sponsors Cogent Biosciences
  • Most Recent Events

    • 27 Jun 2024 According to a Cogent Biosciences media release, the company remain on track to complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by year-end 2025, A subset including the eleven most frequent and severe symptoms will form the basis of the total symptom score (TSS), which will be used to measure the primary endpoint of the SUMMIT Part 2 trial.
    • 27 Jun 2024 According to a Cogent Biosciences media release, the company has reached alignment with the U.S. Food and Drug Administration (FDA) on the Companys novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary (MS2D2), for use in Part 2 of the registration-directed SUMMIT trial evaluating bezuclastinib in Nonadvanced Systemic Mastocytosis (NonAdvSM) patients.
    • 14 Jun 2024 Results (cutoff date, December 18, 2023) ,published in the Cogent Biosciences Media Release
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