(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis (NCT05186753)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (57 Sites)
Showing the first 25 of 57 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Mayo Clinic Arizona — Phoenix, Arizona
- One of a Kind Clinical Research Center — Scottsdale, Arizona
- Modena Allergy and Asthma Clinical — La Jolla, California
- Innovative Research of West Florida — Clearwater, Florida
- Mayo Clinic - Jacksonville — Jacksonville, Florida
- University of South Florida — Tampa, Florida
- Emory University — Atlanta, Georgia
- Rush University — Chicago, Illinois
- Walter Reed National Military Medical Center — Bethesda, Maryland
- Allervie Clinical Research — Glenn Dale, Maryland
- Institute for Asthma and Allergy — Wheaton, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Washington University at St. Louis — St Louis, Missouri
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire
- Duke University — Raleigh, North Carolina
- University of Cincinnati — Cincinnati, Ohio
- The Ohio State University — Columbus, Ohio
- Vanderbilt University Medical Center — Nashville, Tennessee
- AIR Care — Dallas, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Metrodora Institute of Technology — West Valley City, Utah
- Royal Prince Alfred Hospital — Camperdown, New South Wales
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All SSM clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.