Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Primary Endpoint |
The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs). Safety as assessed by the incidence, type and severity of Treatment Emergent Adverse Events (TEAEs) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Treatment Emergent Serious Adverse Events (TEASAEs) |
Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration. |
Incidence of TEAEs leading to study medication or study discontinuation |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Adverse Events of Special Interest (AESI) |
Incidence of Adverse events of special interest (AESIs) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Change from baseline standard laboratory parameters (Hematology) |
Incidence of clinically significant changes in standard laboratory parameters (Hematology) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Change from baseline in standard laboratory parameters (Chemistry) |
Incidence of clinically significant changes from baseline in standard laboratory parameters (Chemistry) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Change from baseline in standard laboratory parameters (Coagulation) |
Incidence of clinically significant changes from baseline standard laboratory parameters (Coagulation) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Inclusion Body Myositis Functional Rating Scale (IBMFRS) |
Mean change from Baseline (Day 1) in IBMFRS over the duration of the study |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Manual Muscle Test 12 (MMT 12) |
Mean change from Baseline (Day 1) in MMT 12 over the duration of the study |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Change from baseline in standard vital signs (respiratory rate) |
Incidence of clinically significant changes in vital signs (respiratory rate) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Change from baseline in standard vital signs blood pressure |
Incidence of clinically significant changes in standard vital signs blood pressure (Systolic and diastolic) blood pressure) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Change from baseline in standard vital signs (temperature) |
Incidence of clinically significant changes in standard vital signs (temperature) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Change from baseline in standard vital signs (pulse rate) |
Incidence of clinically significant changes in standard vital signs (pulse rate) |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Counts of absolute and KLRG1+ lymphocytes by flow cytometry. |
Blood samples will be collected for immunophenotyping. Counts of absolute and KLRG1+ lymphocytes and other lymphocyte subsets will be performed by flow cytometry. |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Presence and titer of antidrug antibodies (ADA) |
The incidence and titers of ADAs to ulviprubart will be evaluated in blood samples |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
| Secondary |
Serum concentration of ulviprubart |
Individual and mean serum concentration time profiles will be presented graphically using nominal time points. |
From Baseline (Day 1) through study completion, an average of 156 weeks.] |
|
