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

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

Interventions

DRUG

Rituximab (R)

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

DRUG

Eculizumab (Soliris®)

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

DRUG

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

DRUG

Satralizumab

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

DRUG

Inebilizumab

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

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• The Sumaira Foundation

  collaborator UNKNOWN

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Philippe-Antoine Bilodeau, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2030-01-31

Completion

2030-05-31

FDA Drug

Yes

Countries

• United States
• Germany

Study Locations