Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody that inhibits B-cell survival and differentiation by neutralizing soluble B lymphocyte stimulator. Belimumab may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tianjin Medical University General Hospital
• Treatments: Belimumab

Criteria

Inclusion Criteria:

1. Male or female patients ≥ 18 years old

2. Diagnosis of NMO or NMO spectrum disorder according to the 2015 International diagnostic criteria for neuromyelitis optic

3. Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months

4. EDSS <= 6.0

5. Combined with or without systemic lupus erythematosus(SLE)

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