Ofatumumab in AQP4-IgG Seropositive NMOSD

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tang-Du Hospital
• Collaborator: Henan Provincial People's Hospital
• Treatments: Ofatumumab

Criteria

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.