Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

• Register: ClinicalTrials.gov
• Last refreshed on: 21 October 2024
• Main ID: NCT05154734
• Date of registration: 07/12/2021
• Prospective Registration: Yes
• Primary sponsor: Tianjin Medical University General Hospital
• Public title: Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders
• Scientific title: Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders (BEAT NMO)
• Date of first enrolment: December 12, 2021
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05154734
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female patients = 18 years old

2. Diagnosis of NMO or NMO spectrum disorder according to the 2015 International Panel
for Neuromyelitis Optica Diagnosis criteria

3. Clinical evidence of either at least one attack requiring rescue therapy
(intravenous corticosteroids, intravenous immunoglobulin, plasma exchange, or a
combination of these therapies) in the year before screening or at least two attacks
requiring rescue therapy in the 2 years before screening.

4. EDSS <= 6.0

5. Patients were seropositive for AQP4-IgG

6. Able and willing to give written informed consent and comply with the requirements
of the study protocol.

Exclusion Criteria:

1. Current evidence or known history of clinically significant infection (Herpes
simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human
immunodeficiency virus, Hepatitis viruses, Syphilis, etc)

2. Participation in another interventional trial within the last 3 months

3. Tumor disease currently or within last 5 years

4. Pregnant, breastfeeding, or child-bearing potential during the course of the study

5. Clinically relevant heart, liver, kidney or bone marrow function disorder


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

Health Condition(s) or Problem(s) studied

NMO Spectrum Disorder

Intervention(s)

Drug: Belimumab

Primary Outcome(s)

The number of attacks [Time Frame: From baseline to one year after]

Secondary Outcome(s)

Determination of serum AQP4 antibodies [Time Frame: From baseline to 52 weeks]

Incidence of treatment-emergent adverse events [safety and tolerability] [Time Frame: From baseline to 52 weeks]

Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Optic nerve,brain and spinal cord Magnetic Resonance Imaging (MRI) [Time Frame: From baseline to 52 weeks]

Worsening in EDSS [Time Frame: Worsening from baseline in EDSS to 52 weeks]

Counts of peripheral blood B cell subsets [Time Frame: From baseline to 52 weeks]

Secondary ID(s)

IRB2021-YX-187-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Tang-Du Hospital