(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
Public ClinicalTrials.gov record NCT05186753. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05186753
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 237 participants
Conditions and interventions
Conditions
Interventions
- Bezuclastinib Tablets (Formulation A) Drug
- Bezuclastinib Tablets (Formulation B) Drug
- Placebo Tablets Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2022 (Actual)
- Primary completion
- May 22, 2025 (Actual)
- Completion
- Apr 2030 (Estimated)
- Last update posted
- May 22, 2026
2022 – 2030
United States locations
- U.S. sites
- 24
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| One of a Kind Clinical Research Center | Scottsdale | Arizona | 85258 | — |
| Modena Allergy and Asthma Clinical | La Jolla | California | 92037 | — |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Rush University | Chicago | Illinois | 60612 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20814 | — |
| Allervie Clinical Research | Glenn Dale | Maryland | 20769 | — |
| Institute for Asthma and Allergy | Wheaton | Maryland | 20902 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Washington University at St. Louis | St Louis | Missouri | 63110 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| Duke University | Raleigh | North Carolina | 27705 | — |
| University of Cincinnati | Cincinnati | Ohio | 45221 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37235 | — |
| AIR Care | Dallas | Texas | 75231 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Metrodora Institute of Technology | West Valley City | Utah | 84119 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05186753, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05186753 live on ClinicalTrials.gov.