inclusion body myositis
Conditions
Brief summary
The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs).
Detailed description
Safety:Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs), Safety: Incidence of TEAEs leading to study medication or study discontinuation, Safety: Clinically significant changes in standard laboratory parameters and vital signs, Safety: Adverse events of special interest (AESIs),, Efficacy: Mean change from Baseline (Day 1) in IBMFRS over the duration of the study., Efficacy: Mean change from Baseline (Day 1) in MMT 12 over the duration of the study
Interventions
DRUGUlviprubart
Sponsors
Abcuro Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety:Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs), Safety: Incidence of TEAEs leading to study medication or study discontinuation, Safety: Clinically significant changes in standard laboratory parameters and vital signs, Safety: Adverse events of special interest (AESIs),, Efficacy: Mean change from Baseline (Day 1) in IBMFRS over the duration of the study., Efficacy: Mean change from Baseline (Day 1) in MMT 12 over the duration of the study | — |
Countries
Belgium, France, Germany
Outcome results
None listed