Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sarilumab · 2 trials · 2 indications
Percent Change from Baseline in C-Reactive Protein (CRP) Levels at Day 4 in Participants with Serum Interleukin 6 (IL-6) Level Greater than the Upper Limit of Normal (ULN) Least Squares (LS) means estimate of percent change from baseline at Day 4 (raw scale) for each treatment group is based on the Analysis of Covariance (ANCOVA) model. It is defined as anti-log of the estimate of dependent variable minus 1, i.e., (exp\[ln(CRP at day 4/Baseline CRP)\]-1. Negative numbers imply improvement in CRP.
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
The ordinal scale is an assessment of the clinical status of a participant The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4: * the time to nadir (or peak) * change from baseline * area under the curve (AUC)
| Arm | Type | Description |
|---|---|---|
| Sarilumab 200mg IV (P2) | EXPERIMENTAL | Phase 2 |
| Sarilumab 200mg IV (P3:C1) | EXPERIMENTAL | Phase 3: Cohort 1 |
| Sarilumab 400mg IV (P2) | EXPERIMENTAL | Phase 2 |
| Sarilumab 400mg IV (P3:C1) | EXPERIMENTAL | Phase 3: Cohort 1 |
| Sarilumab 800mg IV (P3:C2) | EXPERIMENTAL | Phase 3: Cohort 2 |
| Sarilumab 800mg IV (P3: C3) | EXPERIMENTAL | Phase 3: Cohort 3 |
| Sarilumab - dose 1 | EXPERIMENTAL | Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice) |
| Sarilumab - dose 2 | EXPERIMENTAL | Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice) |
| Tocilizumab - dose 1 | ACTIVE_COMPARATOR | Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice) |
| Tocilizumab - dose 2 | ACTIVE_COMPARATOR | Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice) |
| Name | Type | Description |
|---|---|---|
| Sarilumab | DRUG | Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria. |
| Placebo | DRUG | Single or multiple intravenous (IV) doses of placebo to match sarilumab administration |
| Tocilizumab | DRUG | - |
Key Inclusion Criteria: * Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), result from any specimen (or other commercial or public health assay) within 2 weeks prior to randomization and no alternative explanation for current clinical condition * Hospitali...