Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD

NCT06885957 | Recruiting

• 1 other identifier: MabInNMOSD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this registry study is to evaluate the therapeutic efficacy and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.

Conditions

NMO Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Time to first relapse

  Up to 96 weeks

• Median time to relapse

  Up to 96 weeks

• Annualized relapse rate

  Up to 96 weeks

• EDSS score

  Up to 96 weeks

Secondary Outcomes (2)

• Incidence of radiologically identified new gadolinium-enhancing lesions and/or new or enlarging T2-weighted lesions

  Up to 96 weeks

• AQP4-IgG titer in serum and cerebral spinal fluid

  Up to 96 weeks

Study Arms (6)

Inebilizumab treatment

AQP4-IgG positive NMOSD Patient who received Inebilizumab

Drug: Mab Therapy

Satralizumab treatment

AQP4-IgG positive NMOSD Patient who received Satralizumab

Drug: Mab Therapy

Eculizumab treatment

AQP4-IgG positive NMOSD Patient who received Eculizumab

Drug: Mab Therapy

Ofatumumab treatment

AQP4-IgG positive NMOSD Patient who received Ofatumumab

Drug: Mab Therapy

Rituximab treatment

AQP4-IgG positive NMOSD Patient who received Rituximab

Drug: Mab Therapy

Conventional immunosuppressive agents treatment

AQP4-IgG positive NMOSD Patient who received Conventional immunosuppressive agents

Interventions

Mab Therapy DRUG

Whether receive mab therapy or not.

Eculizumab treatment; Inebilizumab treatment; Ofatumumab treatment; Rituximab treatment; Satralizumab treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Confirmed diagnosis of aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorders (NMOSD) per the 2015 International Consensus Diagnostic Criteria, with serological or cerebrospinal fluid verification of AQP4-IgG positivity for inclusion in the AQP4-NMOSD cohort.

You may qualify if:

• Subjects must demonstrate capacity to comprehend the study's objectives and associated risks, provide written informed consent, and authorize utilization of confidential health information in compliance with national and regional data protection regulations.
• Enrollment is permitted regardless of biological sex, with age ≥18 and ≤65 years (inclusive) at the time of informed consent provision.
• All females of childbearing potential and biologically male participants must employ contraceptive measures meeting clinical trial standards throughout the study duration and for at least 30 days following the final administration of investigational therapy. Additionally, participants must abstain from gamete donation during the study period and for ≥30 days post-treatment cessation.
• Neurological examination demonstrating clinical stability within 30 days preceding baseline (Visit 1).

You may not qualify if:

• Medical History and Current Health Status
• Clinically significant medical history of cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, renal, pulmonary, neurological, dermatologic, psychiatric, or other major systemic conditions that, in the investigator's judgment, would preclude safe trial participation.
• Prior cerebrovascular events resulting in a baseline modified Rankin Scale (mRS) score \>3.
• Hypersensitivity to the investigational therapeutic agent(s) or their excipients.
• Infection Risk
• Documented history or positive screening test for human immunodeficiency virus (HIV).
• Active hepatitis C virus (HCV) infection, defined as detectable HCV RNA with concomitant anti-HCV antibody positivity. Subjects with anti-HCV antibody positivity and undetectable HCV RNA remain eligible.
• Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity and/or total hepatitis B core antibody (anti-HBc) positivity. Subjects with prior natural infection (HBsAg-negative, anti-HBc-positive, and anti-HBs-positive) or vaccination-induced immunity (HBsAg-negative, anti-HBc-negative, and anti-HBs-positive) are eligible.
• Chronic, recurrent, or severe infections (e.g., pneumonitis, sepsis) within 90 days prior to baseline (Visit 1).
• History of active tuberculosis (TB) or latent TB infection, defined by positive interferon-gamma release assay (IGRA) results or two consecutive tuberculin skin tests.
• Active bacterial, fungal, or viral infections (including upper respiratory tract infections) within 28 days prior to baseline. Subjects with localized fungal infections (e.g., candidiasis, dermatophytosis) may undergo re-screening post-treatment.
• Contraindications to rescue therapies, including rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or cyclophosphamide.
• Prior exposure to total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, total body irradiation, or hematopoietic stem cell transplantation at any time.
• Clinically significant suicidal ideation or behavior within the past 12 months, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Unwillingness or inability to comply with protocol-mandated procedures.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)