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NCT05186753 · ClinicalTrials.gov registry record · Phase 2
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
A Phase 2 study of Smoldering Systemic Mastocytosis and Mastocytosis, sponsored by Cogent Biosciences.
- Active
- Registry status
- Phase 2
- Development phase
- 237
- Enrollment target
- 20
- Study locations
NCT05186753: Active Phase 2 study of Smoldering Systemic Mastocytosis and Mastocytosis, sponsored by Cogent Biosciences.
NCT05186753 is a Phase 2 study of Smoldering Systemic Mastocytosis and Mastocytosis that is active but no longer recruiting, run by Cogent Biosciences. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05186753, a Phase 2 study of Smoldering Systemic Mastocytosis and Mastocytosis, is active but no longer recruiting, sponsored by Cogent Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 237 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Selection of the recommended dose to be used in subsequent parts of the study.
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 |
What the registry record for NCT05186753 still lists
NCT05186753 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).
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.
NCT05186753 names 20 study sites across 13 states, led by Florida, Maryland, Arizona.
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.
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).
Who is sponsoring clinical trial NCT05186753?
This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Smoldering Systemic Mastocytosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05186753's enrollment target sits among peer trials
237 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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