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(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

NCT05186753 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib. Additionally, a substudy of subjects will investigate the efficacy, safety, and tolerability of bezuclastinib in patients who are experiencing inadequate symptom control with avapritinib.

Conditions

  • SSM
  • Mastocytosis, Indolent
  • Mastocytosis, Systemic
  • Mastocytosis
  • ISM
  • BMM
  • Smoldering Systemic Mastocytosis
  • Bone Marrow Mastocytosis

Interventions

DRUG

Bezuclastinib Tablets (Formulation A)

Bezuclastinib will be administered orally, once daily continuously for 28-day cycles

DRUG

Bezuclastinib Tablets (Formulation B)

Bezuclastinib will be administered orally, once daily continuously for 28-day cycles

DRUG

Placebo Tablets

Placebo will be administered orally, once daily continuously for 28-day cycles

Sponsors & Collaborators

  • Cogent Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Rachael Easton, MD, PhD · Cogent Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2025-05-22
Completion
2030-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186753 on ClinicalTrials.gov