Nonadvanced Systemic Mastocytosis
Conditions
Brief summary
Part 1: Safety assessments (incidence of adverse events [AEs], SAEs); AEs leading to dose modifications; pharmacokinetics (PK) and pharmacodynamic (PD) markers; improvement in symptoms of disease based on PRO measures, Part 2: Week 24 mean absolute change from baseline in an MS2D2 score, Part 3: TEAEs, SAEs, AEs leading to dose modifications; change from baseline in laboratory and ECG results
Detailed description
Part 1: TEAEs, SAEs, AEs leading to dose modifications; change from baseline in laboratory and electrocardiogram (ECG) results, Part 2: Proportion of subjects who had at least 50% reduction in serum tryptase
Interventions
DRUGPlacebo matching CGT9486
DRUGCGT9486
Sponsors
Cogent Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Safety assessments (incidence of adverse events [AEs], SAEs); AEs leading to dose modifications; pharmacokinetics (PK) and pharmacodynamic (PD) markers; improvement in symptoms of disease based on PRO measures, Part 2: Week 24 mean absolute change from baseline in an MS2D2 score, Part 3: TEAEs, SAEs, AEs leading to dose modifications; change from baseline in laboratory and ECG results | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: TEAEs, SAEs, AEs leading to dose modifications; change from baseline in laboratory and electrocardiogram (ECG) results, Part 2: Proportion of subjects who had at least 50% reduction in serum tryptase | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Spain
Outcome results
None listed