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

Conditions

• NMOSD

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

May 31, 2026

Status verified

Mar 2026

Primary completion

Jan 31, 2030

Completion

May 31, 2030

Study Design

Enrollment

540 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Rituximab
• Experimental: Complement inhibitors
  Ravulizumab or eculizumab
• Experimental: Inebilizumab
• Experimental: Satralizumab
• Other: Open-label, non-randomized
  Open-label, non-randomized

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 ]

Central Contacts

• Philippe-Antoine Bilodeau, MD
  617-726-7565
  [email protected]
• Anastasia Vishnevetsky, MD
  617-726-7565
  [email protected]

Locations (2)

Find similar trials in Boston, MA

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