Status:
NOT_YET_RECRUITING
FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord and optic nerves. The objectives of this study are to assess the efficacy and safety of FcRn ant...
Eligibility Criteria
Inclusion
- Male or female, ages 18 to 75.
- Meet the 2015 International Panel of Experts (IPND) diagnostic criteria for neuromyelitis optica spectrum disorders.
- Acute EDSS nadir of 2.5-7.5, and a change of at least 0.5 points from baseline due to an acute relapse event.
- Confirmation of serum AQP4-IgG antibody positivity using the CBA assay.
- Confirmation of an acute attack of neuromyelitis optica spectrum disorders either with an acute optic neuritis and/or acute myelitis, defined as a worsening in the patient's signs and symptoms of neurological/visual impairment, an increase in the EDSS score, and symptoms lasting more than 24 hours and occurring more than 1 month since the last attack. Combination of imaging and clinical evaluation will be used to assess relapse and rule out a pseudorelapse.
- New lesions or enhanced lesions need to be found in MRI.
- Subjects who were receiving immunosuppressive therapy prior to the screening period will be required to agree to discontinue immunosuppression.
- Treatment is stable at least 3 months.
Exclusion
- Other core clinical symptoms besides optic neuritis and myelitis.
- Severe neuromyelitis optica spectrum disorder attack, which in the judgment of the investigator is not appropriate for this study. Severe is defined as requiring assisted ventilation or likely to require assisted ventilation during the study based on the judgment of the investigator.
- Subjects with total IgG levels ≤ 6 g/L at screening.
- Subjects with a B-cell count ≤ 5% of the lower limit of normal at screening.
- Received high-dose intravenous methylprednisolone within 4 weeks prior to the screening period.
- Received intravenous immunoglobulin, plasma exchange, or immunoadsorption treatment within 4 weeks prior to the screening period.
- Received a vaccination within the first 4 weeks of the screening period or planned during the study.
- Using of a monoclonal antibody or investigational drug not mentioned above that has immunomodulatory effects within 3 months or 5 half-lives (whichever is longer) prior to the screening period.
- Subject is known to be allergic to any component of the study drug or any other FcRn drug or contrast medium for enhanced MRI.
- Subject is known to have contraindications to taking methylprednisolone (for subjects in A and B group).
- Subjects with clinically significant active infections (including unresolved or inadequately treated infections, including active tuberculosis) as assessed by the investigator.
- Subjects with positive screening tests for hepatitis B and C who have received live or live attenuated vaccine within 6 weeks prior to baseline.
- Subjects is known unable to taken MRI.
- Subjects is known to have other ophthalmic disease that affect vision as assessed by the investigator.
Key Trial Info
Start Date :
July 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06497374
Start Date
July 5 2024
End Date
June 30 2026
Last Update
July 11 2024
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