(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
SSM · Mastocytosis, Indolent · Mastocytosis, Systemic · Mastocytosis · ISM · BMM · Smoldering Systemic Mastocytosis · Bone Marrow Mastocytosis
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
- +10
Main results were due May 2025, none posted yet
Counts until it's fixed
Score over time
- Stage
- Phase 2
- Patients
- 237 (planned)
- Started
- Jun 27, 2022
- Main results expected
- May 22, 2025
- Fully finished
- Jan 2030
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM
Measured over: 3 months
Part 2: Efficacy of bezuclastinib at the selected dose versus placebo
Measured over: 24 Weeks
Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events
Measured over: Up to 5 years
Changes Tremor has spotted
Show details (technical version)
Score inputs
- results_overdue: base 10, now 10, since 2025-05-22, no fading
Raw record changes
- none yet
Trial ID NCT05186753 · record last updated 2026-10-22 · checked 2026-11-09 15:47 UTC