New antibody treatment could tame rare brain disease Flare-Ups
NCT ID NCT07182409
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether monoclonal antibodies can safely and effectively treat acute attacks of neuromyelitis optica spectrum disorder (NMOSD), a rare disease that causes inflammation in the eyes and spinal cord. Researchers will enroll 40 adults experiencing a recent flare-up and measure changes in disability over six months. The goal is to find better ways to control these attacks and improve recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- monoclonal antibody
- What this could lead to
- If successful, this could point toward a more effective way to treat acute attacks of NMOSD, potentially reducing long-term disability.
- What could go wrong
- This is a small, early-stage study with only 40 participants, so results may not apply to everyone. The treatment may not work better than existing options or could have side effects.
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.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
NMOSD patients with acute attacks
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Age at onset ≥18 years, any gender. 2. Patients meeting the 2015 International Panel for NMO Diagnosis (IPND) criteria for NMOSD and currently in the acute phase, defined as new or significantly worsened neurological deficits lasting \>24 hours, with onset within \<14 days, excluding pseudo-relapses caused by fever, infection, or metabolic disturbances. The acute relapse must meet at least one of the following clinical phenotypes: a) Optic neuritis (ON): EDSS visual function score ≥3; b) Transverse myelitis (TM): EDSS pyramidal function score ≥2. NMOSD-related syndromes (e.g., area postrema syndrome, acute brainstem syndrome, acute diencephalic syndrome, cerebral syndrome) may be present as concomitant features but cannot be the sole or primary manifestation. 3. Serum AQP4-IgG positive by cell-based assay (CBA) with a titer ≥1:32, and negative for MOG-IgG (CBA or LCBA) and GFAP-IgG. 4. Expanded Disability Status Scale (EDSS) score at enrollment ≥3 and ≤8 points. 5. Planned to receive or currently receiving intravenous methylprednisolone (IVMP) treatment, and not on or only using conventional immunosuppressive maintenance therapy. 6. Able to comply with standardized follow-up, with an expected minimum follow-up of 12 months during the study period. 7. Signed informed consent by the patient or legal guardian (if applicable). Exclusion Criteria: 1. Participation in a randomized clinical trial with blinded treatment allocation. 2. Received treatment with monoclonal antibody (including rituximab, satralizumab, inebilizumab, eculizumab, efgartigimod, etc.) within 3 months prior to screening. 3. Received treatment with IVIg, plasma exchange (PE), IVMP, or oral corticosteroids \>30 mg/day within 1 month prior to screening. 4. Incomplete or unavailable follow-up data, expected inability to complete follow-up, or poor compliance. 5. Patients who have independently discontinued immunotherapy or demonstrate poor adherence. 6. Presence of severe underlying diseases or other conditions that may affect the safety of immunotherapy or the interpretation of study results, including but not limited to: a) Chronic or active infections requiring long-term systemic treatment (e.g., progressive multifocal leukoencephalopathy, chronic renal infection, chronic respiratory infection with bronchiectasis, active tuberculosis, active hepatitis C, etc.); b) Positive hepatitis B serology (except in individuals with prior vaccination); c) History or suspicion of tuberculosis; d) Positive HIV serology; e) History or current clinically significant adverse reactions (including severe allergic reactions) related to corticosteroids, FcRn antagonists, or complement inhibitors. 7. Pregnant or breastfeeding women, or women planning pregnancy in the near future (contraception required during treatment). 8. Any other condition deemed by the investigators to make participation in the study inappropriate.
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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