Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002853-31 | EudraCT Number |
Not provided
Not provided
Not provided
The study was withdrawn due to an internal decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to evaluate the efficacy of REGN2477+REGN1033 in combination on total lean mass, as measured by Dual-energy X-ray absorptiometry (DXA) in patients with sporadic inclusion body myositis (sIBM).
The secondary objectives of the study are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN2477+REGN1033 | Experimental | Single, sequential, repeat-dose IV or matching placebo |
|
| Placebo | Experimental | Single, sequential, repeat-dose IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN2477+REGN1033 | Drug | Single, sequential, repeat-dose Intravenous (IV) or matching placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in total lean mass as measured by dual-energy X-ray absorptiometry (DXA) | Up to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Inclusion Body Myositis-Functional Rating Scale (IBM-FRS) | Up to Week 26 | |
| Change in the Sporadic inclusion body myositis (sIBM) Physical Functioning Assessment (sIFA) | Up to Week 26 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol Inclusion/Exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D018979 | Myositis, Inclusion Body |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Matching placebo | Drug | Single, sequential, repeat-dose Intravenous (IV) |
|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Up to Week 30 |
| Percent change in total and regional body composition (including lean mass and fat mass) as measured by DXA | Up to Week 30 |
| Absolute change in total and regional body composition (including lean mass and fat mass) as measured by DXA | Up to Week 30 |
| Change in the 1-repetition maximum (1-RM) chest press strength | Up to Week 26 |
| Change in hand-grip strength as measured by dynamometry | Up to Week 26 |
| Change in distance walked in the 6-minute walk test (6MWT) | Up to Week 26 |
| Change in time to complete the 10-meter walk test (10MWT) | Up to Week 26 |
| Change in instrumented stair climb power | Up to Week 26 |
| Change in instrumented, sensor-based sit-to-stand test time | Up to Week 26 |
| Change in fear of falling as measured via the Falls Efficacy Scale-International (FES-I) | Up to Week 30 |
| Change in Patient Global Impression of Severity assessments (PGIS/PGIC) | Up to Week 30 |
| Change in Patient Global Impression of Change Items assessments (PGIS/PGIC) | Up to Week 30 |
| Change in Clinician Global Impression of Severity assessments (CGIS/CGIC) | Up to Week 30 |
| Change in Clinician Global Impression of Change Items assessments (CGIS/CGIC) | Up to Week 30 |
| Change in 36-item Short Form Health Survey (SF-36), including the Physical Function Items (PF-10) and the Vitality Scale of the SF-36 | Up to Week 30 |
| Change in Thigh muscle volume as measured by MRI (sub-study) | Up to Week 30 |
| Frequency of falls and near-falls as measured by the Hopkins Falls Grading Scale | Up to Week 30 |
| Pharmacokinetics (PK) profile of REGN2477 | Assessed via serum concentration of REGN2477 over time | Up to Week 30 |
| Pharmacokinetics (PK) profile of REGN1033 | Assessed via serum concentration of REGN1033 over time | Up to Week 30 |
| Immunogenicity of REGN2477+REGN1033 | As determined by the presence or absence of anti-drug antibodies (ADA) | Up to Week 30 |
| D009422 |
| Nervous System Diseases |