9 completed, 4 recruiting, 2 not yet recruiting, 1 active not recruiting. 18 Phase 1, 7 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 18 | Completed 9, Recruiting 4, Not yet recruiting 2, Active not recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 2 | 7 | Recruiting 4, Not yet recruiting 1, Terminated 1, Withdrawn 1 |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 |
|---|---|---|---|---|---|---|
| REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants REGN21353, Nezastomig, Sarilumab Prophylaxis (Contingency) - Metastatic Castration-Resistant Prostate Cancer, mCRPC | Phase 1 / Phase 2 | Not yet recruiting | Regeneron Pharmaceuticals | 192 | 2027-06-28 | 2026-09-30 |
| IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD Belumosudil, Sarilumab - cGVHD | Phase 1 | Not yet recruiting | Stanford University | 10 | 2026-09-01 | 2026-08-12 |
| Phase 1b/2 Study of IV Sarilumab in Adult With RA Sarilumab, SAR153191 SC, Sarilumab, SAR153191 IV - Rheumatoid Arthritis | Phase 1 / Phase 2 | Recruiting | Sanofi | 140 | 2026-07-02 | 2026-10-13 |
| 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. Cemiplimab, Kevzara (Sarilumab) - Lung Cancer | Phase 1 | Active not recruiting | M.D. Anderson Cancer Center | 56 | 2023-08-18 | 2026-10-06 |
| Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis Tocilizumab, Sarilumab - Arthritis, Rheumatoid, Interaction | Phase 1 / Phase 2 | Terminated | University of Southern Denmark | 3 | 2021-05-25 | 2023-01-25 |
| A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab REGN5668, Cemiplimab, Ubamatamab - Ovarian Cancer, Fallopian Tube Cancer | Phase 1 / Phase 2 | Recruiting | Regeneron Pharmaceuticals | 612 | 2020-12-08 | 2026-09-24 |
| A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER) Capecitabine, Sarilumab 150mg or 200 mg plus Capecitabine, Sarilumab 150mg plus Capecitabine - Breast, Metastatic | Phase 1 / Phase 2 | Recruiting | University of Southern California | 65 | 2020-09-26 | 2026-03-10 |
| Study to Assess Sarilumab in Halting Progression of Morphea Sarilumab - Morphea, Plaque Form | Phase 1 / Phase 2 | Withdrawn | Massachusetts General Hospital | 2019-09-01 | 2021-09-08 | |
| Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers Ubamatamab, Cemiplimab, Sarilumab - Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer | Phase 1 / Phase 2 | Recruiting | Regeneron Pharmaceuticals | 890 | 2018-05-21 | 2026-09-25 |
| Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis sarilumab SAR153191 (REGN88), tocilizumab - Rheumatoid Arthritis | Phase 1 | Completed | Sanofi | 30 | 2015-05-01 | 2016-03-28 |
| Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA) Sarilumab, Tocilizumab - Rheumatoid Arthritis | Phase 1 | Completed | Regeneron Pharmaceuticals | 105 | 2014-03-01 | 2015-05-05 |
| Sarilumab Effect on the Pharmacokinetics of Simvastatin sarilumab SAR153191 (REGN88), simvastatin - Rheumatoid Arthritis | Phase 1 | Completed | Sanofi | 19 | 2014-01-01 | 2016-04-07 |
| Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis sarilumab SAR153191 (REGN88), placebo, methotrexate - Rheumatoid Arthritis | Phase 1 | Completed | Sanofi | 61 | 2013-04-01 | 2014-01-28 |
| Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients SAR153191 (REGN88) - Rheumatoid Arthritis | Phase 1 | Completed | Sanofi | 32 | 2011-05-01 | 2011-10-24 |
| Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects SAR153191-P3 drug product, SAR153191-P2 drug product, SAR153191-C1F3 drug product - Rheumatoid Arthritis | Phase 1 | Completed | Sanofi | 53 | 2010-07-09 | 2023-12-06 |
| A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects REGN88 - Rheumatoid Arthritis | Phase 1 | Completed | Regeneron Pharmaceuticals | 60 | 2008-12-01 | 2013-09-30 |
| A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis REGN88, Placebo - Rheumatoid Arthritis | Phase 1 | Completed | Regeneron Pharmaceuticals | 32 | 2008-09-01 | 2013-09-30 |
| Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis REGN88 - Rheumatoid Arthritis | Phase 1 | Completed | Regeneron Pharmaceuticals | 15 | 2008-07-01 | 2013-09-30 |
Arthritis, Rheumatoid (11) · Endometrial Neoplasms (2) · Fallopian Tube Neoplasms (2) · Ovarian Neoplasms (2) · Lung Neoplasms (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Prostatic Neoplasms (1) · Recurrence (1) · Scleroderma, Localized (1)
Regeneron Pharmaceuticals (7) · Sanofi (6) · M.D. Anderson Cancer Center (1) · Massachusetts General Hospital (1) · Stanford University (1) · University of Southern California (1) · University of Southern Denmark (1)
United States (11) · Belgium (2) · France (2) · Japan (2) · South Korea (2) · Spain (2) · Australia (1) · Brazil (1) · Denmark (1) · Israel (1) · Italy (1) · Moldova (1) · Netherlands (1) · Russia (1) · United Kingdom (1)
Allen Radin, MD (2) · Allen Radin, M.D. (1) · Anastasia Martynova, MD (1) · Ann-Cathrine Dunvald, MD (1) · Sally Arai, MD (1) · Xiuning Le, MD,PHD (1)
PMID 32453485, PMID 27722854, PMID 30590833, PMID 37831074, PMID 39652449
2019 (1), R01CA238387 (1)