NCT06763848 Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder
| NCT ID | NCT06763848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University |
| Condition | Neuromyelitis Optica Spectrum Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2025-04-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06763848 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Neuromyelitis Optica Spectrum Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06763848 currently recruiting?
Yes, NCT06763848 is actively recruiting participants. Contact the research team at qiuwei120@vip.163.com for enrollment information.
Where is the NCT06763848 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06763848 clinical trial?
NCT06763848 is sponsored by Third Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 144 participants.