Sarilumab

Generic Name
Sarilumab
Brand Names
Kevzara
Drug Type
Biotech
Chemical Formula
-
CAS Number
1189541-98-7
Unique Ingredient Identifier
NU90V55F8I
Background

Sarilumab is a fully human anti-interleukin 6 (IL-6) receptor monoclonal IgG1 antibody that binds to both membrane-bound and soluble IL-6 receptor forms, thus blocking the cis- and trans-inflammatory signalling cascades of IL-6. Sarilumab was developed by Sanofi and Regeneron Pharmaceuticals, Inc; it was US FDA-approved in May 2017 and followed by EU approva...

Indication

Sarilumab is indicated for the 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); and adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tole...

Associated Conditions
Polymyalgia Rheumatica (PMR), Moderate, active Rheumatoid arthritis, Severe, active Rheumatoid arthritis
Associated Therapies
-

Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2019-07-05
Last Posted Date
2023-10-05
Lead Sponsor
Stanford University
Target Recruit Count
16
Registration Number
NCT04008069
Locations
🇺🇸

Stanford University, Palo Alto, California, United States

Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis

First Posted Date
2018-12-10
Last Posted Date
2024-12-17
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
21
Registration Number
NCT03770273
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Study to Assess Sarilumab in Halting Progression of Morphea

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2018-09-20
Last Posted Date
2021-09-08
Lead Sponsor
Massachusetts General Hospital
Registration Number
NCT03679845
Locations
🇺🇸

CURTIS (Massachusetts General Hospital), Boston, Massachusetts, United States

Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

First Posted Date
2018-06-20
Last Posted Date
2024-06-03
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
690
Registration Number
NCT03564340
Locations
🇺🇸

The General Hospital Corporation d/b/a Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇬🇧

University College London Hospitals, London, England, United Kingdom

and more 46 locations

Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics

Phase 3
Conditions
Interventions
First Posted Date
2018-05-24
Last Posted Date
2020-08-11
Lead Sponsor
Gaylis, Norman B., M.D.
Target Recruit Count
20
Registration Number
NCT03535402
Locations
🇺🇸

AARDS Research, Inc, Aventura, Florida, United States

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

First Posted Date
2018-02-28
Last Posted Date
2022-04-28
Lead Sponsor
Sanofi
Target Recruit Count
84
Registration Number
NCT03449758
Locations
🇫🇷

Investigational Site Number 250014, Caen, France

🇫🇷

Investigational Site Number 250006, Besancon, France

🇫🇷

Investigational Site Number 250016, Bordeaux, France

and more 30 locations

An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-05-18
Last Posted Date
2024-10-11
Lead Sponsor
Sanofi
Target Recruit Count
102
Registration Number
NCT02776735
Locations
🇨🇦

Investigational Site Number : 1240112, Montréal, Quebec, Canada

🇨🇱

Investigational Site Number : 1520016, Concepcion, Biobío, Chile

🇫🇷

Investigational Site Number : 2500040, Paris, France

and more 27 locations

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Phase 3
Recruiting
Conditions
Interventions
Other: No systemic corticosteroid
Other: No antiviral agent for COVID-19
Other: No immune modulation for COVID-19
Drug: Standard course macrolide
Other: No antiviral agent for influenza
Drug: Local standard venous thromboprophylaxis
Other: No immunoglobulin
Other: No simvastatin
Other: No cysteamine
Other: No Immune Modulator for Influenza
Other: No vitamin C
Other: No antiplatelet
Procedure: Clinician-preferred mechanical ventilation strategy
Other: No renin-angiotensin system inhibitor
Other: No endothelial modulator
Drug: Ceftriaxone
Drug: Moxifloxacin or Levofloxacin
Drug: Extended course macrolide
Drug: Fixed-duration Hydrocortisone
Drug: Five-days oseltamivir
Drug: Lopinavir / Ritonavir
Biological: Convalescent plasma
Drug: Angiotensin converting enzyme inhibitor
Drug: Nirmatrelvir/ritonavir
Drug: Therapeutic dose anticoagulation
Procedure: Protocolised mechanical ventilation strategy
Drug: Interferon beta-1a
Drug: Vitamin C
Drug: Simvastatin
Drug: Aspirin
Drug: Eritoran
Drug: Cysteamine
Drug: Imatinib
Drug: Shock-dependent hydrocortisone
Drug: Ten-days oseltamivir
Drug: P2Y12 inhibitor
Drug: Angiotensin Receptor Blockers
Drug: Conventional low dose thromboprophylaxis
Biological: Delayed administration of convalescent plasma
Drug: Piperacillin-tazobactam
Drug: Hydroxychloroquine
Drug: Anakinra
Drug: Apremilast
Drug: Baricitinib
Drug: Remdesivir
Drug: Fixed-duration higher dose Hydrocortisone
Drug: Hydroxychloroquine + lopinavir/ritonavir
Drug: Intermediate dose thromboprophylaxis
Drug: Nirmatrelvir/ritonavir + remdesivir
Drug: ARB + DMX-200
Drug: Ceftaroline
Drug: Baloxavir Marboxil
Drug: Tocilizumab
Drug: Amoxicillin-clavulanate
Drug: Fixed-duration dexamethasone
Drug: Five-days oseltamivir + baloxavir marboxil
Drug: Continuation of therapeutic dose anticoagulation
Drug: Ivermectin
Drug: Sarilumab
Drug: Ten-days oseltamivir + baloxavir marboxil
First Posted Date
2016-04-13
Last Posted Date
2024-07-12
Lead Sponsor
UMC Utrecht
Target Recruit Count
20000
Registration Number
NCT02735707
Locations
🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

🇺🇸

University of Illinois Health, Chicago, Illinois, United States

🇦🇺

Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia

and more 405 locations

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

First Posted Date
2015-02-26
Last Posted Date
2018-01-30
Lead Sponsor
Sanofi
Target Recruit Count
91
Registration Number
NCT02373202
Locations
🇯🇵

Investigational Site Number 392039, Fukuoka-Shi, Japan

🇯🇵

Investigational Site Number 392006, Sasebo-Shi, Japan

🇯🇵

Investigational Site Number 392023, Takaoka-Shi, Japan

and more 37 locations
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