Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD

A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222347

Enrollment

Registered

2013-12-26

Start date

2014-02-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)

Interventions

investigational material(s) Generic name etc : SA237 INN of investigational material : satralizumab Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. NMO or NMOSD

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation. 2. Evidence of other demyelinating disease or PML. 3. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.

Design outcomes

Primary

Measure	Time frame
safety efficacy Observation, Examination	—

Secondary

Measure	Time frame
pharmacokinetics pharmacodynamics other other (Immunogenicity) Observation, Examination	—

Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026