New drug hope for rare autoimmune disease? tiny trial begins
NCT ID NCT05504694
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests the drug ofatumumab in 5 people with a rare autoimmune disease called NMOSD. Participants receive injections over 48 weeks. The main goal is to see if the drug reduces the number of relapses compared to before treatment. It is an early, small study focused on safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ofatumumab (a drug injected under the skin)
- What this could lead to
- If it works, this could point toward a new treatment option to reduce relapses in NMOSD.
- What could go wrong
- This is a very small, early-phase pilot study with only 5 participants, so results may not apply to everyone. The drug may not reduce relapses or could cause 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.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jul 2026
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.
- 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: * Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG. * Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months. * Adults aged ≥18 years old. * Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive). * Provision of written informed consent to participate in this study. * Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month. * Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication. Exclusion Criteria: * Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML. * Pregnant or breastfeeding patients and those with family planning during the study period. * Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening. * Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period. * Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression. * Active infection at within 4 weeks before baseline. * Positive for HBV or HCV. * Evidence of latent or active tuberculosis (TB). * Have received any live or live-attenuated vaccine within 6 weeks before baseline. * History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ. * History of severe allergic reactions to biological agents. * Inability to provide written informed consent.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Tangdu Hospital
RECRUITINGXi'an, Shaanxi, China
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