Status:
RECRUITING
Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Neuromyelitis Optica Spectrum Disorder Attack
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, inflammatory autoimmune disorder of the central nervous system characterized by the pathogenic anti-aquaporin 4 antibody (AQP4-IgG). The ...
Eligibility Criteria
Inclusion
- Anti-AQP4 antibody seropositive.
- Male or female patients ≥18 years old
- Body weight ≥ 35 kg
- Acute optic neuritis and/or transverse myelitis enrolled within 28 days from the attack, with a change in neurological exam that meet an increase of OSIS at least 2 points of baseline compared to that of prior attack.
- A female subject is eligible to enter the trial if she is:
- Not pregnant or breastfeeding, not intending to conceive during the course of the trial
Exclusion
- Use of IVIg within 3 weeks prior to screening
- Unresolved meningococcal infection
- Any systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics
- Participation in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening.
- Has previously received treatment with eculizumab
- Hypersensitivity to murine proteins or to one of the excipients of eculizumab
- Any medical condition that, in the opinion of the Investigator, might interfere with thepatient's participation in the trial, poses any added risk for the patient, or confounds the assessment of the patients
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07184840
Start Date
September 9 2025
End Date
December 31 2026
Last Update
September 22 2025
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052