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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Bezuclastinib Tablets (Formulation A)
- DRUG Bezuclastinib Tablets (Formulation B)
- DRUG Placebo Tablets
Study Locations (20)
Florida
- Innovative Research of West Florida — Clearwater
- Mayo Clinic - Jacksonville — Jacksonville
- University of South Florida — Tampa
Maryland
- Walter Reed National Military Medical Center — Bethesda
- Allervie Clinical Research — Glenn Dale
- Institute for Asthma and Allergy — Wheaton
Arizona
- Mayo Clinic Arizona — Phoenix
- One of a Kind Clinical Research Center — Scottsdale
Massachusetts
- Brigham and Women's Hospital — Boston
- Dana Farber Cancer Institute — Boston
Ohio
- University of Cincinnati — Cincinnati
- The Ohio State University — Columbus
Alabama
- University of Alabama at Birmingham — Birmingham
California
- Modena Allergy and Asthma Clinical — La Jolla
Georgia
- Emory University — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2022-06-27 |
| Est. Completion | 2030-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05186753
The ClinicalTrials.gov registry entry for NCT05186753 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 237 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cogent Biosciences, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Smoldering Systemic Mastocytosis appearing as the primary indexed condition, and to 3 interventions — of which Bezuclastinib Tablets (Formulation A) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05186753 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Maryland, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05186753 about?
NCT05186753 is a clinical study titled "(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis". 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 mast...
What is the current status of trial NCT05186753?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2022-06-27. Estimated completion is 2030-04.
What conditions does trial NCT05186753 study?
This clinical trial studies the following conditions: Smoldering Systemic Mastocytosis, Mastocytosis, SSM, Mastocytosis, Indolent, Mastocytosis, Systemic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05186753?
The interventions under investigation include: Bezuclastinib Tablets (Formulation A) (DRUG), Bezuclastinib Tablets (Formulation B) (DRUG), Placebo Tablets (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05186753?
This trial is sponsored by Cogent Biosciences, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05186753 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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