Tests ofatumumab in people with neuromyelitis optica spectrum disorder
Tests ofatumumab in adults with AQP4-positive neuromyelitis optica spectrum disorder.
Plain-language title generated from the registry record
Registry title: Ofatumumab in AQP4-IgG Seropositive NMOSD
Key facts
- Where
- Xi'an, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Tangdu HospitalXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tang-Du Hospital
- Trial code
- NCT05504694
- Record updated
- 30 January 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study
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.
Inclusion: 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: 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; Have received any live or live-attenuated vaccine within 6 weeks before baseline; Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period; Positive for HBV or HCV; Evidence of latent or active tuberculosis (TB); History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ; History of severe allergic reactions to biological agents; 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; Inability to provide written informed consent.