Ofatumumab in AQP4-IgG Seropositive NMOSD

Recruiting now · Phase 1/Phase 2

Conditions studied: Neuromyelitis Optica Spectrum Disorder

In brief

This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.

Key facts

Study ID: NCT05504694
Run by: Tang-Du Hospital
People needed: 5
Starts: 2022-06-28
Expected to finish: 2026-07-31
Last updated by the study team: 2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Tangdu Hospital — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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