NMO Spectrum DisorderNCT06885957
Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
An observational study of NMO Spectrum Disorder, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NMO Spectrum Disorder
- What is being tested?
- Mab Therapy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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. Participants must have provided documented consent for therapeutic intervention with one monoclonal antibody-based biologics.
- Neurological examination demonstrating clinical stability within 30 days preceding baseline (Visit 1).
Who cannot join
- 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).
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- 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.
- Additional Exclusion Criteria
- 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.
- Severe auditory/visual impairment, language barriers, claustrophobia, or other conditions precluding neuropsychological assessments or MRI completion.
- Any other condition deemed by the investigator or sponsor to compromise subject eligibility or study integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ke Shang, PhD, 8602783663477, kay_sang@hust.edu.cn
About this study
Official title: A Registry Study on Monoclonal Antibody-Based Therapies for Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorders
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
- Being tested
- Mab Therapy
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mab TherapyDrug
Whether receive mab therapy or not.
| Study group | Role | What they receive |
|---|---|---|
| Inebilizumab treatment | AQP4-IgG positive NMOSD Patient who received Inebilizumab Receives: Drug: Mab Therapy | |
| Satralizumab treatment | AQP4-IgG positive NMOSD Patient who received Satralizumab Receives: Drug: Mab Therapy | |
| Eculizumab treatment | AQP4-IgG positive NMOSD Patient who received Eculizumab Receives: Drug: Mab Therapy | |
| Ofatumumab treatment | AQP4-IgG positive NMOSD Patient who received Ofatumumab Receives: Drug: Mab Therapy | |
| Rituximab treatment | AQP4-IgG positive NMOSD Patient who received Rituximab Receives: Drug: Mab Therapy | |
| Conventional immunosuppressive agents treatment | AQP4-IgG positive NMOSD Patient who received Conventional immunosuppressive agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first relapse
Measured: Up to 96 weeks
Median time to relapse
Measured: Up to 96 weeks
Annualized relapse rate
Measured: Up to 96 weeks
EDSS score
Measured: Up to 96 weeks
Secondary outcomes (2)
Incidence of radiologically identified new gadolinium-enhancing lesions and/or new or enlarging T2-weighted lesions
Measured: Up to 96 weeks
AQP4-IgG titer in serum and cerebral spinal fluid
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMO Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daishi Tian, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885957
- Sponsor's protocol ID
- MabInNMOSD
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study on Monoclonal Antibody-Based Therapies for Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06885957
- Acronym / sponsor ID
- MabInNMOSD
- Conditions
- NMO Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Inebilizumab treatment | – | Drug: Mab TherapyAQP4-IgG positive NMOSD Patient who received Inebilizumab |
| Satralizumab treatment | – | Drug: Mab TherapyAQP4-IgG positive NMOSD Patient who received Satralizumab |
| Eculizumab treatment | – | Drug: Mab TherapyAQP4-IgG positive NMOSD Patient who received Eculizumab |
| Ofatumumab treatment | – | Drug: Mab TherapyAQP4-IgG positive NMOSD Patient who received Ofatumumab |
| Rituximab treatment | – | Drug: Mab TherapyAQP4-IgG positive NMOSD Patient who received Rituximab |
| Conventional immunosuppressive agents treatment | – | –AQP4-IgG positive NMOSD Patient who received Conventional immunosuppressive agents |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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. Participants must have provided documented consent for therapeutic intervention with one monoclonal antibody-based biologics.
- Neurological examination demonstrating clinical stability within 30 days preceding baseline (Visit 1).
Key exclusion criteria (18 listed)
- Medical History and Current Health Status
- Infection Risk
- Additional Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mab TherapyWhether receive mab therapy or not. | Drug | Eculizumab treatment, Inebilizumab treatment, Ofatumumab treatment, Rituximab treatment, Satralizumab treatment |
Primary outcome
Time to first relapse
Time frame: Up to 96 weeks
Median time to relapse
Time frame: Up to 96 weeks
Annualized relapse rate
Time frame: Up to 96 weeks
EDSS score
Time frame: Up to 96 weeks
2 secondary outcomes
Incidence of radiologically identified new gadolinium-enhancing lesions and/or new or enlarging T2-weighted lesions
Time frame: Up to 96 weeks
AQP4-IgG titer in serum and cerebral spinal fluid
Time frame: Up to 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NMO Spectrum Disorder, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first relapse (time frame: Up to 96 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.