6 completed, 4 recruiting, 3 active not recruiting, 2 terminated. 9 Phase 3, 2 Phase 2, 2 Phase 4, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 5, Active not recruiting 2, Recruiting 1, Terminated 1 |
| Phase 2 | 2 | Active not recruiting 1, Completed 1 |
| Phase 4 | 2 | Recruiting 1, Terminated 1 |
| Early Phase 1 | 1 | Withdrawn 1 |
Follow satralizumab: new trials by email Literature Review of satralizumab trials Research Report on satralizumab
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 |
|---|---|---|---|---|---|---|
| Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD Rituximab (R), Eculizumab (Soliris®), Ravulizumab - NMOSD | Phase 4 | Recruiting | Massachusetts General Hospital | 540 | 2026-09-01 | 2026-09-24 |
| A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD Satralizumab - Neuromyelitis Optica Spectrum Disorders (NMOSD) | Recruiting | Junwei Hao, MD | 50 | 2026-07-20 | 2026-08-13 | |
| A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) Satralizumab - Neuromyelitis Optica Spectrum Disorder, NMOSD | Phase 3 | Recruiting | Hoffmann-La Roche | 8 | 2026-05-06 | 2026-10-01 |
| A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) Satralizumab - Duchenne Muscular Dystrophy | Phase 2 | Active not recruiting | Hoffmann-La Roche | 30 | 2025-04-04 | 2026-09-04 |
| HANDLE-a Real World Study on Satralizumab in NMOSD Satralizumab - Neuromyelitis Optica Spectrum Disorders (NMOSD) | Recruiting | Huashan Hospital | 100 | 2025-03-31 | 2026-09-18 | |
| Satralizumab in Aneurysmal Subarachnoid Hemorrhage Satralizumab - Aneurysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia | Early Phase 1 | Withdrawn | University of Florida | 2024-06-01 | 2025-03-04 | |
| A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease Satralizumab, Placebo - Thyroid Eye Disease | Phase 3 | Completed | Hoffmann-La Roche | 127 | 2023-11-15 | 2026-08-12 |
| Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease Satralizumab, Placebo - Thyroid Eye Disease, TED | Phase 3 | Completed | Hoffmann-La Roche | 131 | 2023-10-26 | 2026-07-31 |
| A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis Satralizumab, Placebo - NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis | Phase 3 | Active not recruiting | Hoffmann-La Roche | 122 | 2022-09-27 | 2026-10-08 |
| A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease Satralizumab, Placebo - Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) | Phase 3 | Active not recruiting | Hoffmann-La Roche | 139 | 2022-08-30 | 2026-10-16 |
| A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention Satralizumab 120 mg - Neuromyelitis Optica Spectrum Disorder, NMOSD | Phase 4 | Terminated | Hoffmann-La Roche | 4 | 2022-08-02 | 2025-01-22 |
| Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial) Satralizumab (Genetical Recombination) - Pulmonary Arterial Hypertension | Phase 2 | Completed | International University of Health and Welfare | 20 | 2022-07-12 | 2026-07-15 |
| A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis Satralizumab, Placebo - Generalized Myasthenia Gravis | Phase 3 | Terminated | Hoffmann-La Roche | 188 | 2021-10-19 | 2025-02-28 |
| A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) satralizumab, azathioprine (AZA), mycophenolate mofetil (MMF) - Neuromyelitis Optica Spectrum Disorder | Phase 3 | Completed | Hoffmann-La Roche | 119 | 2021-03-02 | 2024-12-27 |
| Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) Satralizumab, Placebo - Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD) | Phase 3 | Completed | Hoffmann-La Roche | 95 | 2014-08-05 | 2023-03-01 |
| Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) Satralizumab, Placebo, Baseline Treatment - Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD) | Phase 3 | Completed | Hoffmann-La Roche | 85 | 2014-02-20 | 2023-04-18 |
Neuromyelitis Optica (7) · Graves Ophthalmopathy (2) · Fractures, Bone (1) · Inflammation (1) · Muscular Dystrophy, Duchenne (1) · Myasthenia Gravis (1) · Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (1) · Pulmonary Arterial Hypertension (1) · Subarachnoid Hemorrhage (1)
Hoffmann-La Roche (11) · Huashan Hospital (1) · International University of Health and Welfare (1) · Junwei Hao, MD (1) · Massachusetts General Hospital (1) · University of Florida (1)
United States (13) · Italy (9) · Poland (9) · Japan (7) · South Korea (7) · China (6) · France (6) · Germany (6) · Canada (5) · Spain (5) · Taiwan (5) · Turkey (Türkiye) (5) · Argentina (4) · Ukraine (4) · United Kingdom (4)
Brian Hoh, MD (1) · Chao Quan, Doctor (1) · Jingzi Zhangbao, Doctor (1) · Junwei Hao, MD, PhD (1) · Lei Zhou (1) · Philippe-Antoine Bilodeau, MD (1) · Qiang Dong, Doctor (1) · Wenjuan Huang, Doctor (1) · Yuichi Tamura (1)
PMID 40743487, PMID 36007339, PMID 36724181, PMID 40288333, PMID 41066062, PMID 31774956, PMID 32333898, PMID 39862880
2023 (5), 2015 (1), 2019 (1)