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NCT Number: NCT05154734

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

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.

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Key information

Conditions

NMO Spectrum Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

About this study

The investigators primarily aim to observe the number of attacks from initiation of belimumab treatment.

The secondary outcomes are to determine: The safety profile of belimumab in participants with NMO and whether belimumab improves Expanded Disability Status Scale (EDSS), et al.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belimumab

Drug

Belimumab will be intravenously administered with a dose of 10mg/kg on Days 0,14 and28, then every 28 days until week 48, with a final evaluation at week 52.

Primary outcomes

  1. The number of attacks

    Time frame: From baseline to one year after

    An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack.

Secondary outcomes

  1. Worsening in EDSS

    Time frame: Worsening from baseline in EDSS to 52 weeks

    The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10.

  2. 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

    The total number of new and/or enlarging T2 lesions for all participants was calculated as the sum of the individual number of lesions at Weeks 12, 24, and 52

  3. Counts of peripheral blood B cell subsets

    Time frame: From baseline to 52 weeks

    Compare peripheral blood plasma cells before and one year after initial intervention

  4. Determination of serum AQP4 antibodies

    Time frame: From baseline to 52 weeks

    Compare serum AQP4-ab titers before and one year after initial intervention

  5. Incidence of treatment-emergent adverse events [safety and tolerability]

    Time frame: From baseline to 52 weeks

    Adverse events related to belimumab are recorded

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Collaborators

  • Tang-Du Hospital

Registry information

Official study title

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders (BEAT NMO)

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 13, 2021
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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