Trials / Active Not Recruiting
Active Not RecruitingNCT05186753
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
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 Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 237 (estimated)
- Sponsor
- Cogent Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-06-27
- Primary completion
- 2025-05-22
- Completion
- 2030-04-01
- First posted
- 2022-01-11
- Last updated
- 2026-03-04
Locations
57 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05186753. Inclusion in this directory is not an endorsement.