NCT05154734CompletedPhase 1/2
Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders
Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders (BEAT NMO)
Source: ClinicalTrials.gov · Last updated 16 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 7 Dec 2021
- Start date
- 12 Dec 2021
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Tianjin Medical University General Hospital
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT05154734
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 14
- From 12 Dec 2021 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Tumor disease currently or within last 5 years
- Clinically relevant heart, liver, kidney or bone marrow function disorder
Other
- Participation in another interventional trial within the last 3 months
- Pregnant, breastfeeding, or child-bearing potential during the course of the study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.