Modified Zipper Therapy for AQP4‑antibody–positive NMOSD acute attacks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter, Phase 4 trial comparing a sequential immunomodulation approach — high‑dose corticosteroid pulse therapy followed by plasma exchange and immediate eculizumab — versus the standard sequence of corticosteroids and plasma exchange alone. Adults with confirmed AQP4‑IgG–positive NMOSD presenting within 30 days of an acute attack are enrolled and randomized to the two arms. The primary outcome is neurological improvement at Week 12, with safety monitoring focused on infectious and hematologic risks related to complement inhibition and plasma exchange. The protocol includes predefined entry criteria for severe optic neuritis and longitudinal extensive transverse myelitis and excludes patients with active chronic viral infections or severe coagulation disorders.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants ≥ 18 years of age
2. Definite diagnosis according to the 2015 IPND diagnostic criteria for AQP4-IgG-positive NMOSD
3. Seropositivity for anti-AQP4 antibody.
4. Time from onset to enrollment ≤ 30 days.
5. For patients with optic neuritis: visual acuity ≤ 20/200 at screening; for relapse cases, baseline visual acuity prior to this acute episode must have been ≥ 20/60.
6. For patients with longitudinal extensive transverse myelitis (LETM): EDSS score ≥ 5.5 at screening; for relapse cases, baseline EDSS score prior to this acute episode must have been ≤ 3.5.
7. Ability to understand and voluntarily provide written informed consent-

Exclusion Criteria:

1. Patients with concurrent neuromuscular disorders.
2. Patients with severe coagulation dysfunction.
3. Patients with known allergy to plasma or intravenous immunoglobulin (IVIG).
4. Patients with active hepatitis B or C virus infection, human immunodeficiency virus (HIV) infection, or those deemed at high risk for the onset or reactivation of syphilis or tuberculosis at screening.
5. Patients with active systemic infection at screening, or a history of severe chronic or recurrent infections.
6. Pregnant or lactating patients.
7. Patients with chronic, severe medical conditions that may affect study compliance.
8. Patients with any clinically significant abnormal laboratory findings as determined by the investigator (e.g., severe anemia, leukopenia, thrombocytopenia, etc.).
9. Patients whom the investigator considers unlikely to complete the study or unlikely to comply with the study requirements (for administrative reasons or otherwise).

Where it's running

• Tianjin Medical University General Hospital, Department of Neurology
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Chao Zhang
• Email: chaozhang@tmu.edu.cn
• Phone: +8602260814587

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Satralizumab in the early treatment of NMOSD attacks: a multicenter real-world study

  This study tests whether starting Satralizumab during an NMOSD attack is safe and helpful for adults with AQP4-IgG–positive NMOSD.

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• Satralizumab in NMOSD: Real-world outcomes from China

  This study looks at how satralizumab works for Chinese patients with NMOSD in everyday clinical care by following people over time.

  Recruiting Huashan Hospital · Shanghai, Shanghai Municipality · NCT06829524

• C-CAR168 treatment for autoimmune diseases not responding to standard therapy

  This study is testing a new treatment called C-CAR168 to see if it can help adults with autoimmune diseases that haven't improved with standard therapies.

  Recruiting Phase 1 RenJi Hospital · Shanghai, Shanghai Municipality · NCT06249438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.