NCT02073279

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.

Conditions

• Neuromyelitis Optica (NMO)
• NMO Spectrum Disorder (NMOSD)

Interventions

Type	Name	Description
DRUG	Satralizumab	Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
DRUG	Placebo	Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

Timeline

• Start date: 2014-08-05
• Primary completion: 2018-10-12
• Completion: 2022-01-31
• First posted: 2014-02-27
• Last updated: 2023-03-01
• Results posted: 2020-12-31

Locations

58 sites across 15 countries: United States, Bulgaria, Canada, Croatia, Georgia, Italy, Malaysia, Philippines, Poland, Puerto Rico, Romania, South Korea, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study