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

NCT05403138 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University General Hospital

Phase

Phase 2/3

Started

2022-11-01

Last updated

2025-03-30

Condition(s) studied

Neuromyelitis OpticaNeuromyelitis Optica Spectrum DisorderNMO Spectrum Disorder

Investigational drug(s) / intervention(s)

Daratumumab →Placebo

Daratumumab: Induction Phase: (8mg/kg) via intravenous (IV) evey 2 weeks for two cycles. Maintenance Phase: (4mg/kg) IV every 4 weeks.

Placebo: Induction Phase: matching placebo (8mg/kg) via intravenous (IV) every 2 weeks for two cycles; Maintenance Phase: matching placebo (4mg/kg) IV every 4 weeks.

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 the last 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 Criteria: 1. Use of intravenous steroid pulse therapy or intravenous immunoglobulin or plasma exchange/adsorption within 3 weeks prior to Screening. 2. Use of tocilizumab, satralizumab, belimumab, ofatumumab within 1 months prior to Screening. 3. Patients treated with oral immunosuppressive agents other than steroids (e.g. azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclosporine in the 3 months 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, or those 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 lymphoid irradiation) 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.

Primary outcome measure(s)

Participants With An Adjudicated On-trial Relapse — Baseline, Up To 52 Weeks (End of Study)
An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.

Trial sites (1)

Facility	City	Region	Status
Tianjin Medical University General Hospital	Tianjin	Tianjin Municipality

On this site

📄 Darzalex (daratumumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05403138 on ClinicalTrials.gov ↗ ← All trials in China