RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT07010302

Registry updated: 2026-09-24

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Description

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab. In this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity. Participants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant. This research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.

Interventions

Rituximab (R) (Drug)
1000 mg at weeks 0 and 2 followed by 1000 mg every 6 months
Eculizumab (Soliris®) (Drug)
900 mg weekly for 4 weeks, followed by 1200 mg every 2 weeks
Ravulizumab (Drug)
* 40 to \< 60 kg: 2400 mg * 60 to \< 100 kg: 2700 mg * 100 kg: 3000 mg as an induction dose, followed by * 40 to \< 60 kg: 3000 mg * 60 to \< 100 kg: 3300 mg * 100 kg: 3600 mg Every 8 weeks starting 15 days after loading dose
Satralizumab (Drug)
120 mg at Weeks 0, 2, 4, followed by 120 mg every 4 weeks
Inebilizumab (Drug)
300 mg on Day 1 and Day 15, followed by 300 mg every 6 months

Eligibility criteria

Inclusion Criteria: * Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) consensus criteria. * Seropositivity for AQP4 immunoglobulin G (AQP4-IgG) confirmed by a cell-based assay (either live or fixed) that meets the threshold for positivity set by the local testing laboratory. * Age ≥18 years at the time of consent. * Ability and willingness to provide informed consent and comply with all study procedures, including scheduled visits, laboratory tests, and assessments. * Eligible to receive any of the study drugs based on clinical judgment Exclusion Criteria: * Known active hepatitis B virus (HBV) infection, defined as a positive hepatitis B surface antigen or detectable HBV DNA by PCR. * Known active hepatitis C virus (HCV) infection, defined as detectable HCV RNA by PCR. * Known active or latent tuberculosis, evidenced by a positive interferon-gamma release assay (IGRA) unless fully treated per local guidelines before enrollment. * Known or suspected immunodeficiency disorders, including but not limited to HIV infection with CD4 count \<200 cells/mm³ or any condition requiring chronic immunosuppressive therapy outside the scope of the study drugs. * Pregnancy or breastfeeding, or intention to conceive during the study period. Pregnancy is excluded due to insufficient safety data for the investigational treatments in this population. Women of childbearing potential must agree to use effective contraception throughout the study and for a defined period following the last dose of study drug, per product labeling or institutional guidance. * Any medical, psychiatric, or neurological condition that, in the investigator's opinion, may interfere with study participation, pose additional risk to the participant, or confound interpretation of study results. * Inability or unwillingness to comply with the requirements of the protocol, including scheduled visits, evaluations, or procedures, based on investigator assessment. * Known hypersensitivity or severe allergic reaction to any component of the study drugs or pre-medications required for infusion.

Conditions

NMOSD

Locations

Massachusetts General Hospital — Boston, Massachusetts, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Charité - Universitätsmedizin Berlin — Berlin, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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