sarilumab
sarilumab: sourced relationships with 2 companies · 8 clinical trials tracked · 1 FDA decision.
sarilumab evidence translation
What we can confirm
1 FDA record · 8 tracked trials
What it means
What to watch
Prepared research question
What is verified about sarilumab, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (4)
| Company | Dated record stage |
|---|---|
| REGENERON PHARMACEUTICALS, INC. (REGN) Systemic juvenile idiopathic arthritis (sJIA) | Phase 2 |
| Sanofi (SNY) Reported 2017-05-22 · Current development: unknownSource Polymyalgia Rheumatica; Rheumatoid Arthritis | Phase 4 |
| Sanofi (SNY) Reported 2017-05-22 · Current development: unknownSource | Approved |
| Sanofi (SNY) Reported 2017-05-22 · Current development: unknownSource Polymyalgia Rheumatica; Rheumatoid Arthritis | Phase 4 |
Clinical Trial Registry Records (8)
Phase II Study of Sarilumab With Immune Checkpoint Inhibitor Rechallenge in Patients With Clinically Significant Immune Related Adverse Events (The IRIS Trial: Immune Checkpoint Inhibitor Rechallenge Involving Sarilumab)
Primary endpoint: Safety as assessed by Absence of any grade ≥2 Immune Related Adverse Event (irAE)
A Randomized Open Label, Phase 1b/2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis
Primary endpoint: Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica
Primary endpoint: Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper
A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Primary endpoint: Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
Primary endpoint: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.
Primary endpoint: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
Primary endpoint: Incidence of Dose Limiting Toxicities (DLT)
A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
Primary endpoint: Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with sarilumab?
sarilumab has dated SEC/FDA relationship records for REGENERON PHARMACEUTICALS, INC., Sanofi.
How many clinical trials involve sarilumab?
BioSniper tracks 8 clinical trials involving sarilumab.
What is sarilumab's latest FDA decision?
The most recent tracked FDA decision for sarilumab is Approval for 1 INDICATIONS AND USAGE KEVZARA ® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). ( 1.1 ) adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. ( 1.2 ) patients who weigh 63 kg or greater , dated May 22, 2017.