Ofatumumab in AQP4-IgG Seropositive NMOSD
NCT05504694 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-01-30
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.
Conditions
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
Henan Provincial People's Hospital
collaborator OTHER -
Tang-Du Hospital
lead OTHER
Principal Investigators
-
Jun Guo, M.D. · Tang-Du Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-28
- Primary Completion
- 2026-04-30
- Completion
- 2026-07-31
Countries
- China
Study Locations
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