CompletedPhase 1/2

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

China14 participantsStarted 2021-12-12

Plain-language 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. Clinical trials may be needed to observe its efficacy and safety.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patients ≥ 18 years old
✓. Diagnosis of NMO or NMO spectrum disorder according to the 2015 International Panel for Neuromyelitis Optica Diagnosis criteria
✓. 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.
✓. EDSS \<= 6.0
✓. Patients were seropositive for AQP4-IgG
✓. Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion criteria

✕. 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)
✕. Participation in another interventional trial within the last 3 months
✕. Tumor disease currently or within last 5 years
✕. Pregnant, breastfeeding, or child-bearing potential during the course of the study
✕. Clinically relevant heart, liver, kidney or bone marrow function disorder

What they're measuring

The number of attacks

Timeframe: From baseline to one year after

Trial details

NCT IDNCT05154734

SponsorTianjin Medical University General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More NMO Spectrum Disorder trials