Satralizumab

DRUG15 trials

Sponsors

F. Hoffmann-La Roche AG, Hoffmann-La Roche, University of Florida, Huashan Hospital, Massachusetts General Hospital

Conditions

Aneurysmal Subarachnoid HemorrhageDelayed Cerebral IschemiaDuchenne Muscular DystrophyDuchenne Muscular Dystrophy (DMD)Generalized Myasthenia GravisLGI1 Autoimmune EncephalitisMyelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)NMDAR Autoimmune Encephalitis

Early Phase 1

Satralizumab in Aneurysmal Subarachnoid Hemorrhage

WithdrawnNCT05727657

University of FloridaAneurysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia

Start: 2024-06-30End: 2024-06-24Updated: 2025-03-04

Phase 2

A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)

RecruitingNCT06450639

Hoffmann-La RocheDuchenne Muscular Dystrophy

Start: 2025-04-04End: 2028-06-30Target: 50Updated: 2026-03-27

A Phase II Multicenter, Open-Label Study to evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Pediatric Patients with Duchenne Muscular Dystrophy (SHIELD DMD)

RecruitingCTIS2024-512383-65-00

F. Hoffmann-La Roche AGDuchenne Muscular Dystrophy (DMD)

Start: 2024-09-26Target: 28Updated: 2025-10-31

Phase 3

Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

CompletedNCT02028884

Hoffmann-La RocheNeuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)

Start: 2014-02-20End: 2021-12-23Updated: 2023-04-18

Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

CompletedNCT02073279

Hoffmann-La RocheNeuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)

Start: 2014-08-05End: 2022-01-31Updated: 2023-03-01

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

CompletedNCT04660539

Hoffmann-La RocheNeuromyelitis Optica Spectrum Disorder

Start: 2021-03-02End: 2024-05-28Updated: 2024-12-27

A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

TerminatedNCT04963270

Hoffmann-La RocheGeneralized Myasthenia Gravis

Start: 2021-10-19End: 2024-09-02Updated: 2025-02-28

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)

RecruitingNCT05199688

Hoffmann-La RocheNeuromyelitis Optica Spectrum Disorder, NMOSD

Start: 2026-03-31End: 2029-09-12Target: 8Updated: 2026-03-13

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

RecruitingNCT05271409

Hoffmann-La RocheMyelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Start: 2022-08-30End: 2028-12-31Target: 152Updated: 2026-03-13

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

RecruitingNCT05503264

Hoffmann-La RocheLGI1 Autoimmune Encephalitis, NMDAR Autoimmune Encephalitis

Start: 2022-09-27End: 2029-12-14Target: 152Updated: 2026-04-03

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

Active, not recruitingNCT05987423

Hoffmann-La RocheTED, Thyroid Eye Disease

Start: 2023-10-26End: 2026-07-01Updated: 2026-02-03

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

Active, not recruitingNCT06106828

Hoffmann-La RocheThyroid Eye Disease

Start: 2023-11-15End: 2026-06-25Updated: 2026-02-17

A Phase III, Multicenter, Open-Label, Uncontrolled Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients with AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

RecruitingCTIS2023-507817-85-00

F. Hoffmann-La Roche AGNeuromyelitis Optica Spectrum Disorder (NMOSD)

Start: 2022-04-21Target: 7Updated: 2025-10-23

Phase 4

Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD

Not yet recruitingNCT07010302

Massachusetts General HospitalNMOSD

Start: 2026-05-01End: 2030-05-01Target: 540Updated: 2026-03-16

Unknown Phase

HANDLE-a Real World Study on Satralizumab in NMOSD

Not yet recruitingNCT06829524

Huashan HospitalNeuromyelitis Optica Spectrum Disorders (NMOSD)

Start: 2025-03-31End: 2027-06-30Target: 100Updated: 2025-03-18

Related Papers

Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials.

2025-10-09

Long-Term Efficacy and Safety of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder From the SAkuraMoon Open-Label Extension Study.

2025-07-311 citations

Analysis of infection rates in neuromyelitis optica spectrum disorder: Comparing satralizumab treatment in SAkuraMoon, post-marketing, and US-based health claims data.

2025-04-191 citations

Safety and efficacy of satralizumab in patients with generalised myasthenia gravis (LUMINESCE): a randomised, double-blind, multicentre, placebo-controlled phase 3 trial.

2025-02-0114 citations

Immunogenicity dynamics and covariate effects after satralizumab administration predicted with a hidden Markov model

CPT Pharmacometrics & Systems Pharmacology2024-10-083 citations

Innovation and optimization in autoimmune encephalitis trials: the design and rationale for the Phase 3, randomized study of satralizumab in patients with NMDAR-IgG-antibody-positive or LGI1-IgG-antibody-positive autoimmune encephalitis (CIELO)

Frontiers in Neurology2024-08-1314 citations

Safety and Effectiveness of Satralizumab in Japanese Patients with Neuromyelitis Optica Spectrum Disorder: A 6-month Interim Analysis of Post-marketing Surveillance.

2024-07-165 citations

LUMINESCE, a Phase 3 Study of Satralizumab in Generalized Myasthenia Gravis (gMG): Baseline Characteristics (P10-11.015)

Neurology2024-04-092 citations

Real-world management of patients with neuromyelitis optica spectrum disorder using satralizumab: Results from a Japanese claims database.

2024-02-1211 citations

Long-term Efficacy of Satralizumab in Adults with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from SAkuraMoon (S5.001)

Neurology2023-04-251 citations

Long-term Safety of Satralizumab in Adults with Aquaporin-4-IgG-seropositive (AQP4-IgG+) Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from SAkuraMoon (P13-5.002)

Neurology2023-04-25

SAkuraBONSAI: Protocol design of a novel, prospective study to explore clinical, imaging, and biomarker outcomes in patients with AQP4-IgG-seropositive neuromyelitis optica spectrum disorder receiving open-label satralizumab

Frontiers in Neurology2023-02-176 citations

Long-term Efficacy of Satralizumab in AQP4-IgG-Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar.

2022-12-0837 citations

Long-term safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) from SAkuraSky and SAkuraStar

Multiple Sclerosis and Related Disorders2022-07-0556 citations

Quantifying the relationship between disability progression and quality of life in patients treated for NMOSD: Insights from the SAkura studies.

2021-10-159 citations

Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial.

2020-05-01333 citations

Antibodies to watch in 2020.

2020-01-01328 citations

Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder

New England Journal of Medicine2019-11-27603 citations