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Comparing Five NMOSD Treatments

This study is comparing five medications—rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab—to see which is best at preventing relapses and has fewer side effects for people with Neuromyelitis Optica Spectrum Disorder (NMOSD). NMOSD is a rare autoimmune condition affecting the eyes and spinal cord. We are looking for 540 adults with NMOSD who test positive for a specific antibody called AQP4-IgG. You would be randomly assigned to receive one of these five treatments. The main goals are to measure how long it takes for a safety issue or relapse to occur, up to 48 months.

Study design
This is an interventional study comparing five different treatments. It plans to enroll 540 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 48 months to track safety, tolerability, and relapses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07010302

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

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
Massachusetts General Hospital
~540 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Rituximab (R)Eculizumab (Soliris®)RavulizumabSatralizumabInebilizumab

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to adjudicated safety or tolerability failure
Measured over From date of randomization until the date of first adjudicated safety or tolerability failure or adjudicated relapse, whichever comes first, assessed up to 48 months
+1 more outcome measured

Conditions

NMOSD

Explore related trials

Neuromyelitis OpticaAQP4-IgG

Where it's being run

3 sites across 2 states
Massachusetts2
Germany1

Study leadership

  • Philippe-Antoine Bilodeau, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Philippe-Antoine Bilodeau, MD
[email protected]
617-726-7565
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Time to adjudicated safety or tolerability failureFrom date of randomization until the date of first adjudicated safety or tolerability failure or adjudicated relapse, whichever comes first, assessed up to 48 months

    Includes adverse events, tolerability, patient preference, or logistical barriers.

  • Time to adjudicated relapseFrom date of randomization until the date of adjudicated relapse or first treatment discontinuation, whichever comes first, assessed up to 48 months

    As determined by the blinded Relapse Adjudication Committee using pre-specified clinical and imaging criteria