Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder

Recruiting now · Not applicable

Conditions studied: Neuromyelitis Optica Spectrum Disorders

In brief

To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.

Key facts

Study ID

NCT06763848

Run by

Third Affiliated Hospital, Sun Yat-Sen University

People needed

144

Starts

2025-04-25

Expected to finish

2026-12-31

Last updated by the study team

2025-04-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The inclusion criteria for the study are as follows:
• clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
• Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
• Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
• Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.

You may not qualify if…

• Women who are pregnant or breastfeeding.
• Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.
• Participants with contraindications to intravenous methylprednisolone treatment.
• Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.
• Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.
• Severe Bleeding or Bleeding Disorders
• Severe Heart Failure
• Severe Infections

Where it is running

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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