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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 December 2024
• Main ID: NCT05403138
• Date of registration: 30/05/2022
• Prospective Registration: Yes
• Primary sponsor: Tianjin Medical University General Hospital
• Public title: Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders DAWN
• Scientific title: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders (NMOSD)
• Date of first enrolment: November 1, 2022
• Target sample size: 135
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05403138
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: Fu-Dong Shi, M.D., Ph.D.

• Name: Fu-Dong Shi, M.D., Ph.D.

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica

NMO Spectrum Disorder

Intervention(s)

Drug: Daratumumab

Drug: Placebo

Primary Outcome(s)

Participants With An Adjudicated On-trial Relapse [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Secondary Outcome(s)

Change From Baseline In Hauser Ambulation Index (HAI) Score At End of Study [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Adjudicated On-trial Annualized Relapse Rate (ARR) [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Change From Baseline in Best Corrected Binocular Visual Acuity to the end of study [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Change From Baseline In EuroQoL EQ-5D Index Score At End Of Study [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the end of study [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Change From Baseline In Modified Rankin Scale (mRS) Score At End Of Study [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Change From Baseline In European Quality Of Life (EuroQoL) Health 5-Dimension Questionnaire (EQ-5D) Visual Analogue Scale At End Of Study [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Number of Participants With Adverse Events Serious Adverse Events (SAEs) [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Percentage of Blood Glial Fibrillary Acidic Protein (GFAP) Over Time [Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 48]

Percentage of Blood Neurofilament Light Chain (NFL) Over Time [Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 48]

Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study [Time Frame: Baseline, Up To 52 Weeks (End of Study)]

Blood AQP4-IgG Concentration Over Time [Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 48]

Percentage of Blood Antibody-Secreting Cells (ASCs) Over Time [Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 48]

Secondary ID(s)

2022023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors