Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05186753 | (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis | PHASE2 | ACTIVE NOT_RECRUITING | 237 | — | — | Jun 27, 2022 | Apr 1, 2030 | May 22, 2026 | 57 | United States, Australia +13 |
Selection of the recommended dose to be used in subsequent parts of the study.
Mean absolute change on the Mastocytosis Symptom Severity Daily Diary (MS2D2)
CTCAE v5
| Arm | Type | Description |
|---|---|---|
| (Part 1a) Bezuclastinib Dose 1 + BSC | EXPERIMENTAL | - |
| (Part 1a) Bezuclastinib Dose 2 + BSC | EXPERIMENTAL | - |
| (Part 1a) Placebo + BSC | PLACEBO_COMPARATOR | - |
| (Part 1b) Bezuclastinib Dose 1 + BSC | EXPERIMENTAL | - |
| (Part 1b) Bezuclastinib Dose 2 + BSC | EXPERIMENTAL | - |
| (Part 1b) Placebo + BSC | PLACEBO_COMPARATOR | - |
| (Part 2) Bezuclastinib Selected Dose + BSC | EXPERIMENTAL | - |
| (Part 2) Placebo + BSC | PLACEBO_COMPARATOR | - |
| (Part 3) Bezuclastinib + BSC | EXPERIMENTAL | - |
| (Prior Therapy Sub-study) Bezuclastinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bezuclastinib Tablets (Formulation A) | DRUG | Bezuclastinib will be administered orally, once daily continuously for 28-day cycles |
| Bezuclastinib Tablets (Formulation B) | DRUG | Bezuclastinib will be administered orally, once daily continuously for 28-day cycles |
| Placebo Tablets | DRUG | Placebo will be administered orally, once daily continuously for 28-day cycles |
Key Inclusion Criteria: 1. Diagnosed with 1 of the following diagnoses according to the 2016 World Health Organization (WHO) classification for systemic mastocytosis (SM): * Indolent systemic mastocytosis (ISM), * Bone marrow mastocytosis (BMM) * Smoldering systemic mastocytosis (SSM) 2. ...