Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders

Last updated: March 28, 2025
Sponsor: Tianjin Medical University General Hospital
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Neuromyelitis Optica And Neuromyelitis Optica Spectrum Disorders

Multiple Sclerosis

Treatment

Placebo

Daratumumab

Clinical Study ID

NCT05403138
2022023
  • Ages > 18
  • All Genders

Study 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 anti-aquaporin-4 (AQP4) antibody-positive. NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord, optic nerves, and area postrema. It is usually mediated by the pathogenic AQP4-IgG. Antibody-secreting cells (ASCs) have been recognized as essential sources of AQP4-IgG. CD38 is a glycoprotein that is highly expressed on ASCs. Daratumumab, a CD38-directed monoclonal antibody, has been shown to decrease the levels of autoantibodies in lupus, myasthenia gravis, or autoimmune encephalitis. This randomized controlled study aims to evaluate the therapeutic potential of daratumumab in NMOSD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female participants ≥ 18 years old.

  2. Diagnosis of NMO or NMOSD.

  3. Anti-AQP4 antibody seropositive.

  4. Historical relapse of at least 1 relapses in the last 12 months or 2 relapses in thelast 24 months with at least 1 relapse in the 12 months prior to the screening.

  5. Expanded Disability Status Scale score ≤ 7.5.

  6. Patients must give written informed consent.

Exclusion

Exclusion Criteria:

  1. Use of intravenous steroid pulse therapy or intravenous immunoglobulin or plasmaexchange/adsorption within 3 weeks prior to Screening.

  2. Use of tocilizumab, satralizumab, belimumab, ofatumumab within 1 months prior toScreening.

  3. Patients treated with oral immunosuppressive agents other than steroids (e.g.azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclosporine in the 3months prior to allocation.

  4. Use of rituximab or inebilizumab within 6 months prior to Screening.

  5. Patients infected with hepatitis B or C virus, or human immunodeficiency virus, orthose having active infectious diseases.

  6. Patients with a severe chronic infection or a history of recurrent infections.

  7. Patients with a history of radiation treatment (whole body irradiation or lymphoidirradiation) or stem cell transplantation.

  8. Patients who are pregnant or breast-feeding.

  9. Patients who are participating in other clinical trials for NMOSD.

  10. Patients diagnosed with cancer.

Study Design

Total Participants: 135
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
November 01, 2022
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

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