Recruiting

Rituximab vs. Ravulizumab, Inebilizumab, Satralizumab, Eculizumab

Sponsor:

Massachusetts General Hospital

Code:

NCT07010302

Conditions

NMOSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rituximab (R)

Eculizumab (Soliris®)

Ravulizumab

Satralizumab

Inebilizumab

Study Details

Brief summary:

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.

Conditions

NMOSD

Study ID

NCT07010302

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Rituximab

experimental: Complement inhibitors

Ravulizumab or eculizumab

experimental: Inebilizumab

experimental: Satralizumab

other: Open-label, non-randomized

Open-label, non-randomized

Interventions

Rituximab (R)

1000 mg at weeks 0 and 2 followed by 1000 mg every 6 months

Eculizumab (Soliris®)

900 mg weekly for 4 weeks, followed by 1200 mg every 2 weeks

Ravulizumab

  • 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

120 mg at Weeks 0, 2, 4, followed by 120 mg every 4 weeks

Inebilizumab

300 mg on Day 1 and Day 15, followed by 300 mg every 6 months

Primary outcome measure

  • Time to adjudicated safety or tolerability failure [ Time Frame: 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 ]
  • Time to adjudicated relapse [ Time Frame: From date of randomization until the date of adjudicated relapse or first treatment discontinuation, whichever comes first, assessed up to 48 months ]

Central Contacts and Locations

Central contacts

Philippe-Antoine Bilodeau, MD

617-726-7565pbilodeau@mgh.harvard.edu

Anastasia Vishnevetsky, MD

617-726-7565avishnevetsky@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Levy, MD

(617) 726-7565mlevy11@mgh.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Shamik Bhattacharyya, MD

(617) 726-7565sbhattacharyya3@bwh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.