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Sarilumab

Phase 2

COVID-19 | Small molecule | Infectious Disease |Regeneron Pharmaceuticals, Inc.|Last Updated: Sep 23, 2021

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment1,912
FDA Designations
No designations recorded
Clinical trial landscape

Sarilumab · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT04315298Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19COVID-19
COMPLETED1,912 Analytics
PHASE2COMPLETED
Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
COVID-19Unlock trial analytics
Study Endpoints
Primary Endpoints
Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2)
Baseline and Day 4

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.

Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1)
Day 22

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

Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2)
Day 22

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

PD parameters
baseline through week 4

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)

Secondary Endpoints
Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2)
Up to Day 29
Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2)
Up to Day 29
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2)
Up to Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sarilumab 200mg IV (P2)EXPERIMENTALPhase 2
Sarilumab 200mg IV (P3:C1)EXPERIMENTALPhase 3: Cohort 1
Sarilumab 400mg IV (P2)EXPERIMENTALPhase 2
Sarilumab 400mg IV (P3:C1)EXPERIMENTALPhase 3: Cohort 1
Sarilumab 800mg IV (P3:C2)EXPERIMENTALPhase 3: Cohort 2
Sarilumab 800mg IV (P3: C3)EXPERIMENTALPhase 3: Cohort 3
Sarilumab - dose 1EXPERIMENTALSingle subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Sarilumab - dose 2EXPERIMENTALSingle SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab - dose 1ACTIVE_COMPARATORSingle intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab - dose 2ACTIVE_COMPARATORSingle IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Interventions
NameTypeDescription
SarilumabDRUGSingle or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.
PlaceboDRUGSingle or multiple intravenous (IV) doses of placebo to match sarilumab administration
TocilizumabDRUG -
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites62

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...

Countries:United States
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