Treatment for acute episodes of neuromyelitis optica spectrum disorder using protein A immunoadsorption

Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial

This study is testing whether a new treatment using protein A immunoadsorption can help people with neuromyelitis optica spectrum disorder feel better during acute flare-ups compared to just using high-dose steroids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06763848 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of protein A immunoadsorption therapy in treating acute exacerbations of neuromyelitis optica spectrum disorders (NMOSD). It is a multicenter, open-label, superiority randomized controlled trial that plans to enroll 144 patients. Participants will receive either protein A immunoadsorption combined with high-dose intravenous methylprednisolone or high-dose intravenous methylprednisolone alone. The study seeks to provide comprehensive clinical evidence to support treatment protocols for NMOSD during acute phases.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a clinical diagnosis of acute NMOSD who test positive for AQP4-IgG.

Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to intravenous methylprednisolone will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients experiencing acute episodes of NMOSD.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating NMOSD with immunoadsorption techniques.

Eligibility criteria

Inclusion Criteria:

* The inclusion criteria for the study are as follows:

  1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
  2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
  3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
  4. 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.

Exclusion Criteria:

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

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Wei Qiu, Ph.D

Conditions Neuromyelitis Optica Spectrum Disorders; neuromyelitis optica spectrum disorders; immunoadsorption; acute episodes; treatment