Major trial to determine best drug for rare autoimmune disease
NCT ID NCT07010302
First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 4 times
Summary
This study compares five FDA-approved drugs—rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab—to see which best prevents relapses in people with neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune condition that can cause vision loss and paralysis. About 160 adults who test positive for a specific antibody will be randomly assigned to one of the drugs and followed for up to four years. The goal is to find the most effective and safest treatment to help patients and doctors make informed choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab, ravulizumab, inebilizumab, satralizumab, eculizumab
- What this could lead to
- If this trial succeeds, it could identify which of these five drugs best prevents relapses and has fewer side effects, helping patients and doctors choose the most effective treatment for NMOSD.
- What could go wrong
- This is a comparative effectiveness trial, not a test of new drugs. All medications are already approved, so the main uncertainty is which works best in real-world use. Results may not apply to all patients, and side effects are possible with each drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 540 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for NMOSD are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
-
Charité - Universitätsmedizin Berlin
Berlin, Germany
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can pregnancy and neurological disease coexist safely? a new registry seeks answers
- New hope for NMOSD patients: drug aims to slash relapse rate
- Immune reset: CAR-T therapy targets lupus, MS, and more
- New registry to monitor Real-World effects of NMOSD treatments
- Hormone clues sought in rare nerve disease
- New hope for rare autoimmune disease: eculizumab trial targets relapses