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Clinical Trials in China / NCT05504694
Recruiting Phase 1/2

Ofatumumab in AQP4-IgG Seropositive NMOSD

NCT05504694 · tracked via the Priya Life Science China tracker
Sponsor
Tang-Du Hospital
Phase
Phase 1/2
Started
2022-06-28
Last updated
2026-01-30

Condition(s) studied

Neuromyelitis Optica Spectrum Disorder

Investigational drug(s) / intervention(s)

Ofatumumab

Ofatumumab: The enrolled patients will receive ofatumumab (20 mg/0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks. The first 4 infusions will be administered at study center site; subsequent infusions will be given in the patient's home with a nurse online interview to administer the infusion.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tangdu Hospital Xi'an Shaanxi Recruiting

More Tang-Du Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05504694 on ClinicalTrials.gov ↗ ← All trials in China