FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack

Sponsor
Tianjin Medical University General Hospital
Study ID
NCT06497374
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • NMO Spectrum Disorder
  • Neuromyelitis Optica
  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod Alfa Injection — DRUG
    Efgartigimod+IVMP; IVMP; Efgartigimod
  • High-dose intravenous methylprednisolone — DRUG
    Efgartigimod+IVMP; IVMP; Efgartigimod

Study Details

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.

Key Dates

Start date
Jul 5, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod+IVMP group
    Patients will receive efgartigimod alpha via intravenous infusion at a dose of 10 mg/kg, each infusion lasting approximately 2 hours, on Week 0, 1, 2 and 3. Efgartigimod should be administered no later than the second day after initiation of high-dose intravenous methylprednisolone therapy. This is delivered intravenously at a dosage of 1,000 mg/day for five consecutive days, which is then reduced to 500 mg/day for the next three days, followed by 240 mg/day for another three days, and then 120 mg/day for an additional three days. Subsequently, the treatment shifts to oral prednisone, starting with 60 mg daily for seven days, then decreasing to 50 mg daily for the next seven days, followed by 40 mg daily for another seven days. Afterward, the prednisone dosage is reduced by 5 mg every two weeks until it reaches 10 mg. After Week 4, Inebilizumab to prevent relapse will be introduced according to the indication.
  • Experimental: IVMP group
    Patients will be treated with injectable methylprednisolone sodium succinate as described in Arm A. After Week 4, Inebilizumab to prevent relapse will be introduced according to the indication.
  • Other: Efgartigimod group
    Patients will be treated with efgartigimod alpha injection via intravenous infusion at a dosage of 10 mg/kg, with each session lasting approximately 2 hours, on Week 0, 1, 2 and 3. After Week 4, Inebilizumab to prevent relapse will be introduced according to the indication.

Primary Outcome Measure

Change in Neurological Disability - Expanded Disability Scale Score [ Time Frame: Acute nadir to week4 ]

Central Contacts

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