NCT07420296RecruitingPhase 3
Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder
Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder: A Multicenter Randomized Controlled Trial Study
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
Study Title: A National, Multicenter, Randomized Controlled Trial of the Modified Zipper Therapy in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (ELITE Study) Brief Summary: The goal of this clinical trial is to evaluate the efficacy and safety of a novel sequential immunomodulation strategy, termed "Modified Zipper Therapy," in patients with acute attacks of Aquaporin-4 antibody-positive Neuromyelitis Optica Spectrum Disorder (AQP4-IgG+ NMOSD). The therapy aims to enhance neurological recovery by combining plasma exchange (PE) with immediate complement inhibition using eculizumab, following high-dose corticosteroid pulse therapy. The main questions this trial aims to answer are: Efficacy: Does the Modified Zipper Therapy (high-dose corticosteroids + plasma exchange + eculizumab) lead to a higher rate of neurological improvement at Week 12 compared to standard therapy (high-dose corticosteroids + plasma exchange alone)? For patients with NMOSD-related optic neuritis (NMOSD-ON), improvement is defined as a gain of ≥10 letters on the ETDRS chart or a decrease of ≥0.2 LogMAR in best-corrected visual acuity (BCVA). For patients with NMOSD-related longitudinally extensive transverse myelitis (NMOSD-LETM), improvement is defined as a reduction of ≥2 points on the Expanded Disability Status Scale (EDSS). Safety: What is the nature and frequency of adverse events experienced by participants receiving the Modified Zipper Therapy compared to those receiving standard therapy? Researchers will compare the Modified Zipper Therapy group to the Standard Therapy group to see if the novel combination is more effective in improving visual and functional outcomes in acute AQP4-IgG+ NMOSD. Participants will: Be randomly assigned (like a coin toss) to receive either the Modified Zipper Therapy or the Standard Therapy. Undergo a treatment period involving intravenous corticosteroids and a series of plasma exchange sessions. The Modified Zipper Therapy group will also receive intravenous eculizumab infusions timed around the plasma exchange procedures. Be followed for 24 weeks after treatment completion. Attend scheduled clinic visits for comprehensive assessments including: Visual acuity testing (using ETDRS, Snellen, and low-contrast charts). Neurological function evaluations (EDSS and OSIS scores). Optical coherence tomography (OCT) and visual evoked potential (VEP) tests. Magnetic resonance imaging (MRI) scans of the optic nerves. Safety monitoring (physical exams, lab tests, ECGs).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Tianjin Medical University General Hospital
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT07420296
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 198
- From 1 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concurrent neuromuscular disorders.
Other illness
- Patients with known allergy to plasma or intravenous immunoglobulin (IVIG).
- 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.
- Patients with active systemic infection at screening, or a history of severe chronic or recurrent infections.
- Patients with chronic, severe medical conditions that may affect study compliance.
Lab values
- Patients with any clinically significant abnormal laboratory findings as determined by the investigator (e.g., severe anemia, leukopenia, thrombocytopenia, etc.).
Other
- Patients with severe coagulation dysfunction.
- Pregnant or lactating patients.
- Patients whom the investigator considers unlikely to complete the study or unlikely to comply with the study requirements (for administrative reasons or otherwise).
Who the study is looking for
- Participants ≥ 18 years of age
- Definite diagnosis according to the 2015 IPND diagnostic criteria for AQP4-IgG-positive NMOSD
- Seropositivity for anti-AQP4 antibody.
- Time from onset to enrollment ≤ 30 days.
- 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.
- 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.
- Ability to understand and voluntarily provide written informed consent-
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University General Hospital, Department of Neurology Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.