Actively Recruiting
Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study
Led by Tang-Du Hospital · Updated on 2026-01-30
5
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
T
Tang-Du Hospital
Lead Sponsor
H
Henan Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ofatumumab in adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are AQP4-IgG seropositive. NMOSD is a rare and serious disorder that mainly affects adults and involves an immune response against the aquaporin-4 water channel. Monoclonal antibodies targeting CD20 have been effective in preventing relapses, and this study aims to assess ofatumumab, a fully humanized anti-CD20 antibody approved for multiple sclerosis, for NMOSD treatment in China. In this open-label, single-arm, multicenter pilot study, participants receive ofatumumab (20 mg/0.4 ml) as a subcutaneous injection at baseline, Day 7, Day 14, and then monthly for a total of 48 weeks. The first four doses are administered at the study center, while subsequent doses are given at home with a nurse conducting online interviews to supervise the infusion. Participants will be monitored through various assessments including changes in annual relapse rate, disability status (EDSS), lesion burden on MRI, optic coherence tomography measures, circulating B cell subsets, immune landscape, biochemical indicators, functional questionnaires, and adverse events. These evaluations occur at baseline and at multiple time points up to 12 months. The study's total duration for each participant is approximately 48 weeks, with continuous safety and efficacy monitoring throughout this period.
CONDITIONS
Brief Title
Ofatumumab in AQP4-IgG Seropositive NMOSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 2 years or older.
- 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 permitted at screening (up to 10 mg equivalent per day), which should be stopped within one month.
- Effective contraception used for female patients with fertility during treatment or at least 3 months after stopping medication.
You will not qualify if you...
- Progressive neurological deterioration unrelated to NMOSD relapses or suspected progressive multifocal leukoencephalopathy (PML).
- Pregnant or breastfeeding patients and those with family planning during the study period.
- Participation in any other clinical therapeutic study at screening or within 30 days before screening.
- History of splenectomy or no spleen, and planned surgery (excluding minor surgery) during the study period.
- Uncontrolled severe concurrent diseases, long-term use of glucocorticoids or immunosuppressants due to other autoimmune diseases, or other chronic diseases preventing immunosuppression.
- Active infection within 4 weeks before baseline.
- Positive for hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Evidence of latent or active tuberculosis.
- Receipt of any live or live-attenuated vaccine within 6 weeks before baseline.
- History of malignancy in past 5 years, including solid tumors, malignant blood disorders, and carcinoma in situ.
- History of severe allergic reactions to biological agents.
- Inability to provide written informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive ofatumumab by subcutaneous injection starting at baseline, Day 7, Day 14, and monthly thereafter for a total of 48 weeks. The first 4 injections are administered at the study center; subsequent injections are given at home with nurse supervision via online interview.
Approximately 4 visits at study center followed by monthly home visits with nurse online interviews
Trial Site Locations
Total: 1 location
1
Tangdu Hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
J
Jun Guo, M.D.
Y
Yan Jia, M.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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