Not Yet RecruitingPhase 2

FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack

63 participantsStarted 2024-07-05

Plain-language 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 antagonists (efgartigmod) for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. The potential of efgartigimod, an IgG1 Fc fragment that competes with IgG for FcRn binding, thereby lowering IgG levels, warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks. This study aims to evaluate the therapeutic potential of efgartigmod in acute NMOSD attack.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

What they're measuring

Change in Neurological Disability - Expanded Disability Scale Score

Timeframe: Acute nadir to week4

Trial details

NCT IDNCT06497374

SponsorTianjin Medical University General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Fu-Dong Shi

+8602260814587 fshi@tmu.edu.cn

View on ClinicalTrials.gov More Neuromyelitis Optica trials