Clinical Trial

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

Study acronym: DAWN
Active, Not Recruiting Phase 2/3
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Record status
This record was last updated March 30, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-05-30; most recent amendment 2025-03-28.
Status change: Recruiting → Active, Not Recruiting 2025-03-28
Status change: Not Yet Recruiting → Recruiting 2022-10-19
Trial Details
NCT Number NCT05403138
Lead Sponsor Tianjin Medical University General Hospital
Conditions Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, NMO Spectrum Disorder
Enrollment 135 participants
Start Date 2022-11-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-30