A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225027

Enrollment

Registered

2020-01-20

Start date

2019-10-15

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), neuromyelitis optica spectrum disorders (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: Patients diagnosed as having either: - NMO as defined by 2006 criteria - NMOSD as defined by either of the following Wingerchuk 2007 criteria with anti aquaporin 4 antibody (AQP4Ab) seropositive status at screening - NMOSD as defined by 2015 criteria

Exclusion criteria

Exclusion criteria: (1) Patients who have history of Alemtuzumab, total body irradiation, or marrow transplant (2) Any previous treatment with anti-cluster of differentiation (CD) 20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline (3) Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline. (4) Treatment with any investigational agent within 3 months prior to baseline.

Design outcomes

Primary

Measure	Time frame
safety Observation / inspection	—

Secondary

Measure	Time frame
pharmacokinetics other other (Immunogenecity) Observation / inspection	—

Countries

Japan

Outcome results

None listed

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