13 completed, 3 recruiting, 3 terminated, 1 active not recruiting. 22 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 22 | Completed 13, Recruiting 3, Terminated 3, Active not recruiting 1, Suspended 1, Unknown 1 |
| Phase 2 | 5 | Completed 3, Active not recruiting 1, Suspended 1 |
Follow sarilumab: new trials by email Literature Review of sarilumab trials Research Report on sarilumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica Sarilumab, Placebo - Polymyalgia Rheumatica | Phase 3 | Recruiting | Sanofi | 300 | 2026-05-12 | 2026-10-21 |
| Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Squaric Acid Dibutyl Ester, Known patch test allergens, Dupilumab - Skin Inflammation, Allergic Contact Dermatitis | Phase 2 / Phase 3 | Active not recruiting | Wei-Che Ko | 45 | 2022-11-15 | 2026-06-09 |
| Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO Sarilumab, Azithromycin, Hydroxychloroquine - COVID19, SARS-CoV-2 Infection | Phase 2 / Phase 3 | Suspended | Assistance Publique - Hôpitaux de Paris | 27 | 2020-04-11 | 2020-05-06 |
| Sarilumab COVID-19 Sarilumab SAR153191, Placebo - Corona Virus Infection | Phase 3 | Completed | Sanofi | 420 | 2020-03-28 | 2025-09-24 |
| Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI Sarilumab - Corona Virus Infection | Phase 2 / Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 239 | 2020-03-27 | 2025-06-12 |
| Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 Sarilumab, Placebo - COVID-19 | Phase 2 / Phase 3 | Completed | Regeneron Pharmaceuticals | 1912 | 2020-03-18 | 2021-09-23 |
| Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors GSK3196165 (Otilimab), Sarilumab, Placebo to GSK3196165/ Sarilumab - Arthritis, Rheumatoid | Phase 3 | Completed | GlaxoSmithKline | 550 | 2019-10-31 | 2023-07-17 |
| Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA Sarilumab SAR153191, Sarilumab matching placebo, Prednisone - Giant Cell Arteritis | Phase 3 | Terminated | Sanofi | 83 | 2018-11-20 | 2022-03-28 |
| Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica Sarilumab SAR153191 (REGN88), Sarilumab-matching placebo, Prednisone - Polymyalgia Rheumatica | Phase 3 | Terminated | Sanofi | 118 | 2018-10-09 | 2022-06-10 |
| Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics Sarilumab - Rheumatoid Arthritis | Phase 3 | Unknown | Gaylis, Norman B., M.D. | 20 | 2018-06-01 | 2020-08-11 |
| Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia Ceftriaxone + Macrolide, Moxifloxacin or Levofloxacin, Piperacillin-tazobactam + Macrolide - Respiratory Tract Diseases, Influenza (Pandemic) | Phase 3 | Recruiting | UMC Utrecht | 20000 | 2016-04-11 | 2026-11-04 |
| 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) Sarilumab, Sulfasalazine, Leflunomide - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 91 | 2015-02-01 | 2018-01-30 |
| Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH) Sarilumab, Adalimumab, Placebo (for sarilumab) - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 369 | 2015-01-28 | 2022-03-28 |
| A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI) Sarilumab SAR153191 (REGN88), Placebo (for sarilumab), Methotrexate - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 243 | 2014-11-01 | 2018-01-30 |
| To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) sarilumab SAR153191 (REGN88) - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 132 | 2014-06-01 | 2017-06-20 |
| To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis Sarilumab, Auto-Injector Device (AID), Pre-filled Syringe (PFS) - RA | Phase 3 | Completed | Sanofi | 217 | 2014-03-01 | 2017-06-20 |
| An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate Sarilumab, Etanercept, Methotrexate - Rheumatoid Arthritis | Phase 3 | Terminated | Sanofi | 776 | 2013-04-01 | 2017-07-27 |
| To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) sarilumab SAR153191 (REGN88), tocilizumab, hydroxychloroquine - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 202 | 2013-03-01 | 2017-06-26 |
| To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) Sarilumab, placebo, hydroxychloroquine - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 546 | 2012-10-01 | 2017-08-08 |
| Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) SAR153191 (REGN88) - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 2023 | 2010-06-21 | 2022-03-28 |
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Arthritis, Rheumatoid (12) · COVID-19 (3) · Coronavirus Infections (3) · Polymyalgia Rheumatica (2) · Community-Acquired Pneumonia (1) · Dermatitis (1) · Dermatitis, Allergic Contact (1) · Giant Cell Arteritis (1) · Influenza, Human (1) · Lung Diseases (1) · Pneumonia (1) · Respiratory Distress Syndrome (1) · Respiratory Tract Diseases (1) · Respiratory Tract Infections (1)
Sanofi (14) · Assistance Publique - Hôpitaux de Paris (2) · Gaylis, Norman B., M.D. (1) · GlaxoSmithKline (1) · Regeneron Pharmaceuticals (1) · UMC Utrecht (1) · University of Nebraska (1) · Wei-Che Ko (1)
United States (17) · Spain (12) · Germany (11) · Hungary (11) · Russia (11) · Czechia (10) · Argentina (9) · Canada (9) · Israel (9) · Italy (9) · Poland (9) · Belgium (8) · Chile (8) · France (8) · United Kingdom (8)
Colin McArthur, Dr (1) · Derek Angus, Prof (1) · James R O'Dell, MD (1) · John Marshall, Prof (1) · Lennie Derde, MD (1) · Luis Felipe Reyes, MD, MSc, PhD (1) · Marc Bonten, Prof (1) · Mark C Genovese, MD, Professor of Medicine (1) · Steve Webb, Prof (1) · Wei-Che Ko, MD (1)
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