(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

← catalyst calendar

NCT05186753

Sponsored by Cogent Biosciences, Inc. (industry) · COGT — their whole pipeline →.

Phase

Phase 2

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

237estimated

Sites

Countries

Australia, Belgium, Canada +12

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-06-27

actual

When the study began enrolling

Primary completion

2025-05-22

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

Apr 2030

estimated

The whole study's end, after follow-up

First posted

2022-01-11

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-22

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

SSM
Mastocytosis, Indolent
Mastocytosis, Systemic
Mastocytosis
ISM
BMM
Smoldering Systemic Mastocytosis
Bone Marrow Mastocytosis

Interventions

Drug: Bezuclastinib Tablets (Formulation A) — also filed as CGT9486, PLX9486
Drug: Bezuclastinib Tablets (Formulation B) — also filed as CGT9486, PLX9486
Drug: Placebo Tablets

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM

measured 3 months

Part 2: Efficacy of bezuclastinib at the selected dose versus placebo

measured 24 Weeks

Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events

measured Up to 5 years

Permalink · COGT's whole pipeline · Catalyst calendar · Every registered study · What changed