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...
Sarilumab is an investigational drug being studied for COVID-19 and rheumatoid arthritis. In COVID-19, it is being evaluated in hospitalized patients. For rheumatoid arthritis, it has been studied in adults. It is currently in Phase 2 clinical development for these indications.
Sarilumab targets the IL6R, which is the interleukin-6 receptor. It acts as an antagonist, meaning it blocks the activity of this receptor. By targeting IL6R, Sarilumab is designed to modulate inflammatory pathways involved in conditions like rheumatoid arthritis and COVID-19.
Sarilumab is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company. Regeneron's stock is traded under the ticker symbol REGN. The company is conducting clinical trials to evaluate Sarilumab's safety and efficacy in various patient populations.
Sarilumab is in Phase 2 clinical development. It has completed a Phase 2 trial in hospitalized patients with COVID-19, which enrolled 1,912 participants. The drug is investigational and has not been approved by regulatory authorities for any indication.
Sarilumab has been studied in clinical trials including NCT04315298, a Phase 2 trial in hospitalized patients with COVID-19, and NCT02097524, a Phase 1 trial in adults with rheumatoid arthritis. Both trials are completed. The COVID-19 trial enrolled 1,912 participants in the United States.
Sarilumab is also known by the brand name Kevzara. It is a biologic drug that targets the IL6 receptor. In clinical trials, it has been evaluated for rheumatoid arthritis and COVID-19, with studies conducted in the United States.