Ofatumumab for AQP4‑antibody positive neuromyelitis optica spectrum disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, single‑arm, multicenter Phase 1/2 pilot trial in China testing ofatumumab in adults with AQP4‑IgG seropositive NMOSD who experienced at least two relapses in the past 24 months. Participants receive ofatumumab and are followed for clinical relapses, disability measured by EDSS, and safety outcomes. Key entry criteria include age ≥18, confirmed AQP4‑IgG positivity, EDSS 0–7.5, and limited concurrent oral corticosteroid use. The protocol builds on the effectiveness of anti‑CD20 therapy in NMOSD and onatumumab's approval for multiple sclerosis to gather prospective efficacy and safety data in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tangdu Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Jun Guo, M.D. — Tang-Du Hospital
• Study coordinator: Jun Guo, M.D.
• Email: guojun_81@163.com
• Phone: 86-29-8477 8844

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.