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

Latest Information Update: 16 Jun 2025

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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

  • 11 Jun 2025 According to a Cogent Biosciences Media Release, An additional $100 million is available during 2025 at Cogent's discretion, subject to successful top-line data readouts from SUMMIT and PEAK bezuclastinib pivotal trials.
  • 27 Feb 2025 According to a Cogent Biosciences Media Release, top-line results from SUMMIT Part 2 are on track for July 2025.
  • 27 Feb 2025 According to a Cogent Biosciences Media Release, data presented at the 2025 American Academy of Allergy Asthma & Immunology/World Allergy Organization (AAAAI/WAO) Joint Congress taking place February 28-March 3, 2025 in San Diego, CA will focus on the patients who received 100 mg bezuclastinib for at least 48 weeks.

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