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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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Mar 2, 2026, no change to tracked fieldsv20-v21
  2. Study sites: 69 to 57v19
  3. Enrollment target: 207 to 237
    • Primary completion date changed from estimate of Sep 2025 to May 22, 2025
    • Study arms: 9 to 10
    v18
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 73 to 69
    v17
  5. Enrollment target: 138 to 207
    • Study sites: 67 to 73
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 13 to 14
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date: Nov 2024 to Sep 2025
    • Study sites: 51 to 67
    • Study completion date: Nov 2026 to Apr 2030
    v15
  2. Study sites: 38 to 51v14
  3. Study sites: 36 to 38v13
  4. Study sites: 31 to 36v12
  5. Study sites: 24 to 31v11
  6. Study sites: 21 to 24v10
  7. Study sites: 18 to 21v9
  8. Study sites: 16 to 18v8
  9. Study sites: 14 to 16v7
  10. Start date: Oct 26, 2021 to Jun 27, 2022v6 Show 6 more changesShow less
    • Primary endpoints: 2 to 3
    • Study sites: 10 to 14
    • Interventions: CGT9486 Tablets (Drug), Placebo Tablets (Drug) to Bezuclastinib Tablets (Formulation A) (Drug), Bezuclastinib Tablets (Formulation B) (Drug), Placebo Tablets (Drug)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 10 to 13
    • Study arms: 7 to 9
  11. Study sites: 9 to 10v5
  12. Study sites: 6 to 9
    • Start date changed from estimate of Apr 2022 to Oct 26, 2021
    v4
  13. Study sites: 4 to 6
    • Start date: Mar 2022 to Apr 2022
    v3
  14. Study sites: 1 to 4
    • Start date: Jan 2022 to Mar 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05186753
Lead Sponsor Cogent Biosciences, Inc.
Conditions
(from sponsor)		 SSM, Mastocytosis, Indolent, Mastocytosis, Systemic, Mastocytosis, ISM, BMM, Smoldering Systemic Mastocytosis, Bone Marrow Mastocytosis
Related terms Hematologic Diseases, Hypersensitivity, Immune Complex Diseases, Immune System Diseases, Mastocytosis, Mastocytosis, Systemic
Enrollment 237 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov