Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objectives of this time-to-event study are to assess the efficacy and safety of Daratumumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who are ant...
Eligibility Criteria
Inclusion
- Male or female participants ≥ 18 years old.
- Diagnosis of NMO or NMOSD.
- Anti-AQP4 antibody seropositive.
- Historical relapse of at least 1 relapses in the last 12 months or 2 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening.
- Expanded Disability Status Scale score ≤ 7.5.
- Patients must give written informed consent.
Exclusion
- Use of intravenous steroid pulse therapy or intravenous immunoglobulin or plasma exchange/adsorption within 3 weeks prior to Screening.
- Use of tocilizumab, satralizumab, belimumab, ofatumumab within 1 months prior to Screening.
- Patients treated with oral immunosuppressive agents other than steroids (e.g. azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclosporine in the 3 months prior to allocation.
- Use of rituximab or inebilizumab within 6 months prior to Screening.
- Patients infected with hepatitis B or C virus, or human immunodeficiency virus, or those having active infectious diseases.
- Patients with a severe chronic infection or a history of recurrent infections.
- Patients with a history of radiation treatment (whole body irradiation or lymphoid irradiation) or stem cell transplantation.
- Patients who are pregnant or breast-feeding.
- Patients who are participating in other clinical trials for NMOSD.
- Patients diagnosed with cancer.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05403138
Start Date
November 1 2022
End Date
December 1 2025
Last Update
March 30 2025
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052