inclusion body myositis
Conditions
Brief summary
For Part B: The primary endpoint of the study will be mean change from Baseline (Day 1) in IBMFRS at W76. For Part C: The endpoint for Part C of the study will be PD recovery as assessed by the time from EOT/ETV to recovery of KLRG1+ cells.
Detailed description
Efficacy: 1. Mean change from Baseline (Day 1) in MMT 12 at W76; 2. Mean change from Baseline (Day 1) in hand grip strength by dynamometry at W76; Safety: 1. Incidence, nature, and severity of TEAEs; 2. Incidence, nature, and severity of TESAEs; Please refer to protocol for a complete list of the efficacy and safety secondary Endpoints.
Interventions
DRUGPlacebo to Test Product
DRUGUlviprubart
Sponsors
Abcuro Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Mean change from Baseline (Day 1) in MMT 12 at W76; 2. Mean change from Baseline (Day 1) in hand grip strength by dynamometry at W76; Safety: 1. Incidence, nature, and severity of TEAEs; 2. Incidence, nature, and severity of TESAEs; Please refer to protocol for a complete list of the efficacy and safety secondary Endpoints. | — |
Primary
| Measure | Time frame |
|---|---|
| For Part B: The primary endpoint of the study will be mean change from Baseline (Day 1) in IBMFRS at W76. For Part C: The endpoint for Part C of the study will be PD recovery as assessed by the time from EOT/ETV to recovery of KLRG1+ cells. | — |
Countries
Belgium, France, Germany
Outcome results
None listed