Neuromyelitis OpticaNCT07159893
Inectolizumab With Steroid Optimization in Newly Treated NMOSD
A study testing Inebilizumab + Rapid Steroid Tapering group and Inebilizumab + Standard Steroid Tapering group in people with Neuromyelitis Optica and Autoimmune Diseases, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromyelitis Optica, Autoimmune Diseases, Demyelinating Autoimmune Diseases, CNS
- What is being tested?
- Inebilizumab + Rapid Steroid Tapering group and Inebilizumab + Standard Steroid Tapering group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients who meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and are AQP4-IgG positive, with a first-attack episode;
- Male or female,age >=18 and <=65 years old;
- EDSS score ≤ 7.5;
- Female subjects of childbearing potential must have a negative pregnancy test result during the screening period and must use effective contraception throughout the study period;
- Voluntarily sign the informed consent form.
Who cannot join
- Laboratory abnormalities include: (white blood cell count < 3×10⁹/L), (neutrophils < 1.5×10⁹/L), (hemoglobin < 85 g/L), (platelet count < 80×10⁹/L), (serum creatinine > 1.5×ULN), (total bilirubin > 1.5×ULN), (AST (GOT) > 3×ULN), (ALT (GPT) > 3×ULN), (alkaline phosphatase > 2×ULN).
- Patients currently suffering from active hepatitis or with a history of severe liver disease are ineligible. Based on the following serological test results for HBsAg, anti-HBc antibodies, and anti-HBs antibodies, there is evidence of hepatitis B virus (HBV) infection: Patients with positive HBsAg should be excluded. For patients with negative HBsAg but positive anti-HBc antibodies, regardless of whether anti-HBs antibodies are positive or negative, HBV-DNA testing is required to determine their status: If HBV-DNA is positive, the patient should be excluded; if HBV-DNA is negative, the patient may be eligible for the trial.
- Patients with other chronic active immune system diseases, or those with stable conditions but requiring glucocorticoid therapy, are excluded, except for neuromyelitis optica spectrum disorder (NMOSD). Examples include rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic immunodeficiency, or drug-induced immunodeficiency. Patients with only positive autoantibodies but without clinical manifestations may be eligible for the trial.
- Pregnant women, breastfeeding women, and patients who plan to conceive during the trial period.
- Allergic reactions: Patients with a history of allergies to contrast agents administered via the parenteral route or to human-derived biological products.
- Patients who received a live vaccine, except for the herpes zoster vaccine, within 28 days prior to randomization.
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- Patients who have used rituximab or other monoclonal antibodies within 6 months prior to randomization
- Patients who have received intravenous immunoglobulin (IVIG) within 28 days prior to randomization.
- Patients who have undergone hematopoietic stem cell transplantation or lymphocyte irradiation before randomization.
- Patients who have used immunosuppressive agents such as azathioprine (Azathioprine, AZA, half-life t1/2 = 6 hrs), mycophenolate mofetil (Mycophenolate Mofetil, t1/2 = 16 hrs), leflunomide (Leflunomide, LEF, t1/2 = 14.7 hrs), tacrolimus (Tacrolimus, t1/2 = 43 hrs), teriflunomide (Teriflunomide, t1/2 = 18 days), cyclosporine (Cyclosporin, CsA, t1/2 = 27 hrs), methotrexate (Methotrexate, MTX, t1/2 = 14 hrs), mitoxantrone (Mitoxantrone, NVT, t1/2 = 37 hrs), and cyclophosphamide (Cyclophosphamide, CTX, t1/2 = 6 hrs) before randomization are excluded. Except for leflunomide and teriflunomide, patients can be enrolled if the washout period exceeds five half-lives. For leflunomide and teriflunomide, patients need to undergo cholestyramine washout as follows: take 8 grams of cholestyramine orally three times daily for 11 days. If the 8-gram dose is not tolerated, it can be changed to 4 grams per dose, with the same frequency and duration.
- Patients who have received any investigational drug within 28 days or five half-lives of the trial drug (whichever is shorter) before randomization.
- Patients with symptoms of severe mental illness who are clinically unable to co-operate;
- Patients with malignant tumours.
- Patients who have experienced any of the following events within 12 weeks prior to randomization: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) Class IV heart failure.
- Patients with herpes zoster infection, positive for HCV antibodies, or positive for HIV antibodies during the screening period.
- Patients who are unable to undergo magnetic resonance imaging (MRI) during the trial period.
- Patients whom the investigator deems unsuitable for participation in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease
Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels.
Study Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.
Read the detailed description
Research Objectives:
- To investigate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG-positive neuromyelitis optica spectrum disorder (NMOSD) patients.
- To evaluate the efficacy of early inebilizumab initiation during acute attacks in improving EDSS scores and its safety profile in treatment-naïve AQP4-IgG+ NMOSD patients.
Research Background: Neuromyelitis optica spectrum disorder (NMOSD) is a rare, relapsing autoimmune disease characterized by inflammatory demyelination of the central nervous system, predominantly affecting young to middle-aged women and typically manifesting as optic neuritis and longitudinally extensive transverse myelitis, often causing irreversible neurological damage and significant disability. The pathogenesis centers on AQP4-IgG-mediated immune attacks through complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity, leading to astrocyte damage and neuroinflammation, with B cells and IL-6 playing key roles in disease progression. While traditional therapies (corticosteroids and immunosuppressants) have limited efficacy and significant side effects, newly approved biologics (inebilizumab, eculizumab, satralizumab) targeting B cells, complement, or IL-6 pathways have shown promising results in reducing relapses. Our preliminary data suggest early inebilizumab initiation during acute attacks (within 7-10 days) may improve neurological function (EDSS scores) while enabling rapid steroid tapering without increasing relapse risk. This study aims to systematically evaluate the feasibility and safety of accelerated steroid reduction during inebilizumab therapy in treatment-naïve AQP4-IgG+ NMOSD patients, while assessing the efficacy of early biologic intervention, with the goal of optimizing treatment strategies, improving patient outcomes, and informing future clinical guidelines.
Research Design: This prospective, randomized controlled trial will evaluate the steroid-sparing efficacy and safety profile of inebilizumab in treatment-naïve AQP4-IgG+ neuromyelitis optica spectrum disorder (NMOSD) patients. The study specifically aims to: (1) quantify inebilizumab's glucocorticoid dose-reduction potential, (2) assess its safety in acute-phase administration (initiated within 7-10 days of disease onset), and (3) measure treatment impact on disability outcomes (EDSS improvement). By systematically investigating whether early biologic intervention facilitates both rapid steroid tapering and neurological recovery, this research will generate critical evidence to optimize precision therapy for NMOSD patients.
Treatment Protocol：
Eligible NMOSD patients (n=25) will be randomized into two groups:
- Experimental Group(n=12): Inebilizumab on Day 1 and Day 15. Oral steroids (60 mg qod)after second dose, halved every 2 weeks, stopped at Week 12.
- Active comparator(n=13): Inebilizumab on Day 1 and Day 15. Oral steroids (60 mg qod) after second dose, halved every 4 weeks, stopped at Week 24.
Initial Treatment (Both Groups):
Days 1-5 (D1-D5): Methylprednisolone 1.0g IV daily (first infusion day designated as D1)；Day 6 (D6): Switch to oral prednisone 60mg daily for 14 days + initiate first inebilizumab 300mg IV infusion ；Day 20 (D20): Second inebilizumab 300mg IV (15 days after first dose)；Week 24: Third inebilizumab 300mg IV
Steroid Tapering Schedules:
- Rapid-Taper Group: D20: Prednisone reduced to 60mg every other day (EOD) D34 (after 2 weeks): Reduce to 30mg EOD D48 (after 2 weeks): Reduce to 15mg EOD D62 (after 2 weeks): Reduce to 10mg EOD D76 (after 2 weeks): Reduce to 5mg EOD D90 (Week 12): Discontinue steroids
- Standard-Taper Group: D20-D34: Continue prednisone 60mg daily for 4 weeks D34: Reduce to 60mg EOD D62 (after 4 weeks): Reduce to 30mg EOD D90 (after 4 weeks): Reduce to 15mg EOD D118 (after 4 weeks): Reduce to 10mg EOD D146 (after 4 weeks): Reduce to 5mg EOD D174 (Week 24): Discontinue steroids
Study Visits and Assessments:
- Five scheduled visit timepoints Baseline (Visit 1, Week 0): First inebilizumab administration Visit 2 (Week 2) Visit 3 (Week 4) Visit 4 (Week 12) Visit 5 (Week 24)
- Visit Procedures Visit 1:Laboratory tests (CBC, biochemistry, IgA/IgM/IgG levels, lymphocyte subsets)、MRI (brain/orbital/spinal)、Serum markers (AQP4-IgG, NFL, GFAP)、Clinical assessments (EDSS, Hauser Ambulation Index) Visit 2:Adverse event assessment Laboratory tests (CBC, biochemistry, IgA/IgM/IgG, lymphocyte subsets)、Clinical assessments Visit 3:Adverse event assessment、Clinical assessments Visit 4:Adverse event assessment Laboratory tests (CBC, biochemistry, IgA/IgM/IgG, lymphocyte subsets, serum markers)、Clinical assessments Visit 5:Full repeat of Visit 1 assessments
- Being tested
- Inebilizumab + Rapid Steroid Tapering group, Inebilizumab + Standard Steroid Tapering group
- Medical subject headings
- Neuromyelitis Optica, Autoimmune Diseases, Demyelinating Autoimmune Diseases, CNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inebilizumab + Rapid Steroid Tapering groupDrug
Also called Inebilizumab with rapid glucocorticoid taper group
Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-19: 60 mg daily；Day 20: 60 mg every other day (EOD)
；Day 34: 30 mg EOD → Day 48: 15 mg EOD → Day 62: 10 mg EOD → Day 76: 5 mg EOD → Day 90: Discontinue Route: Oral
Inebilizumab + Standard Steroid Tapering groupDrug
Also called Inebilizumab with standard glucocorticoid taper group
Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-34: 60 mg daily;Day 34: 60 mg EOD → Day 62: 30 mg EOD → Day 90: 15 mg EOD → Day 118: 10 mg EOD → Day 146: 5 mg EOD → Day 174:Discontinue; Route: Oral
| Study group | Role | What they receive |
|---|---|---|
| Inebilizumab with Rapid Steroid Tapering group | Experimental | Participants receive:
1. Acute-phase: Methylprednisolone 1.0g IV daily (Days 1-5)
2. Maintenance-phase:
* Day 6: Prednisone 60mg po daily + Inebilizumab 300mg IV
* Day 20: Second inebilizumab 300mg IV + Prednisone reduced to 60mg po every other day
3. Steroid tapering schedule:Day 34→30mg EOD → Day 48→15mg EOD → Day 62→10mg EOD → Day 76→5mg EOD → Day 90→Discontinue
4. Long-term: Third inebilizumab 300mg IV at Week 24 Receives: Drug: Inebilizumab + Rapid Steroid Tapering group |
| Inebilizumab with Standard Steroid Tapering group | Active comparator | Participants receive:
1. Acute-phase (Days 1-5):Methylprednisolone 1.0g IV daily
2. Maintenance-phase:
* Day 6: Prednisone 60mg po daily +First inebilizumab 300mg IV
* Day 20: Second inebilizumab 300mg IV+Continue prednisone 60mg po daily until Day 34
3. Steroid Tapering Schedule:
Day 34→60mg EOD → Day 62→30mg EOD → Day 90→15mg EOD → Day 118→10mg EOD → Day 146→5mg EOD → Day 174→Discontinue
4. Long-term: Third inebilizumab 300mg IV at Week 24 Receives: Drug: Inebilizumab + Standard Steroid Tapering group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the average daily dose of corticosteroids between the two groups during the follow-up period compared to randomization (i.e., baseline
Record the corticosteroid dose for patients at randomization (baseline) and during the follow-up period
Measured: Baseline, Week 2, Week 4, Week 12, Week 24
Time to first clinical relapse
Accurately document the time of symptom onset in patients.
Measured: From the date of randomization (baseline) to the date of first documented clinical relapse (as defined by protocol criteria), assessed up to 24 weeks.
Secondary outcomes (4)
The change in EDSS (Expanded Disability Status Scale) score from.
Before patients enter the study (i.e., at randomization) and at each follow-up time point during the study period, the disability status of patients is assessed by a trained neurologist or study nurse, and the EDSS scores at baseline and follow-up time points are recorded.
Measured: Baseline,Week 2, Week 4, Week 12, Week 24
The incidence, severity, and outcomes of adverse events in each group of patients
Record the occurrence, severity, and outcomes of adverse events in patients at baseline and follow-up time points.
Measured: Baseline, Week 2, Week 4, Week 12, Week 24
Area Under the Dose-Time Curve of Corticosteroids (AUDTC)
Record the corticosteroid dose for patients at Week 24. Calculate the total area under the dose-time curve (AUDTC) by dividing the dose-time curve into multiple trapezoids, calculating the area of each trapezoid, and then summing these areas.
Measured: Week 24
The change in the Hauser Walking Index from baseline for each group of patients.
At baseline and follow-up time points, patients are required to walk 25 feet (approximately 8 meters) on a flat surface, and the time taken is recorded. The score is then determined according to the time taken to walk this distance and whether any assistive devices are used, in accordance with the scoring criteria.
Measured: Baseline, Week 2, Week 4, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis OpticaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Zhang, Bachelor, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159893
- Sponsor's protocol ID
- KY2025-076
- Status last verified
- Sep 2025
- First submitted
- 10 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease
- ClinicalTrials.gov ID
- NCT07159893
- Acronym / sponsor ID
- KY2025-076
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Sep 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.
Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels.
Study Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.
Detailed description
Research Objectives:
- To investigate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG-positive neuromyelitis optica spectrum disorder (NMOSD) patients.
- To evaluate the efficacy of early inebilizumab initiation during acute attacks in improving EDSS scores and its safety profile in treatment-naïve AQP4-IgG+ NMOSD patients.
Research Background: Neuromyelitis optica spectrum disorder (NMOSD) is a rare, relapsing autoimmune disease characterized by inflammatory demyelination of the central nervous system, predominantly affecting young to middle-aged women and typically manifesting as optic neuritis and longitudinally extensive transverse myelitis, often causing irreversible neurological damage and significant disability. The pathogenesis centers on AQP4-IgG-mediated immune attacks through complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity, leading to astrocyte damage and neuroinflammation, with B cells and IL-6 playing key roles in disease progression. While traditional therapies (corticosteroids and immunosuppressants) have limited efficacy and significant side effects, newly approved biologics (inebilizumab, eculizumab, satralizumab) targeting B cells, complement, or IL-6 pathways have shown promising results in reducing relapses. Our preliminary data suggest early inebilizumab initiation during acute attacks (within 7-10 days) may improve neurological function (EDSS scores) while enabling rapid steroid tapering without increasing relapse risk. This study aims to systematically evaluate the feasibility and safety of accelerated steroid reduction during inebilizumab therapy in treatment-naïve AQP4-IgG+ NMOSD patients, while assessing the efficacy of early biologic intervention, with the goal of optimizing treatment strategies, improving patient outcomes, and informing future clinical guidelines.
Research Design: This prospective, randomized controlled trial will evaluate the steroid-sparing efficacy and safety profile of inebilizumab in treatment-naïve AQP4-IgG+ neuromyelitis optica spectrum disorder (NMOSD) patients. The study specifically aims to: (1) quantify inebilizumab's glucocorticoid dose-reduction potential, (2) assess its safety in acute-phase administration (initiated within 7-10 days of disease onset), and (3) measure treatment impact on disability outcomes (EDSS improvement). By systematically investigating whether early biologic intervention facilitates both rapid steroid tapering and neurological recovery, this research will generate critical evidence to optimize precision therapy for NMOSD patients.
Treatment Protocol：
Eligible NMOSD patients (n=25) will be randomized into two groups:
- Experimental Group(n=12): Inebilizumab on Day 1 and Day 15. Oral steroids (60 mg qod)after second dose, halved every 2 weeks, stopped at Week 12.
- Active comparator(n=13): Inebilizumab on Day 1 and Day 15. Oral steroids (60 mg qod) after second dose, halved every 4 weeks, stopped at Week 24.
Initial Treatment (Both Groups):
Days 1-5 (D1-D5): Methylprednisolone 1.0g IV daily (first infusion day designated as D1)；Day 6 (D6): Switch to oral prednisone 60mg daily for 14 days + initiate first inebilizumab 300mg IV infusion ；Day 20 (D20): Second inebilizumab 300mg IV (15 days after first dose)；Week 24: Third inebilizumab 300mg IV
Steroid Tapering Schedules:
- Rapid-Taper Group: D20: Prednisone reduced to 60mg every other day (EOD) D34 (after 2 weeks): Reduce to 30mg EOD D48 (after 2 weeks): Reduce to 15mg EOD D62 (after 2 weeks): Reduce to 10mg EOD D76 (after 2 weeks): Reduce to 5mg EOD D90 (Week 12): Discontinue steroids
- Standard-Taper Group: D20-D34: Continue prednisone 60mg daily for 4 weeks D34: Reduce to 60mg EOD D62 (after 4 weeks): Reduce to 30mg EOD D90 (after 4 weeks): Reduce to 15mg EOD D118 (after 4 weeks): Reduce to 10mg EOD D146 (after 4 weeks): Reduce to 5mg EOD D174 (Week 24): Discontinue steroids
Study Visits and Assessments:
- Five scheduled visit timepoints Baseline (Visit 1, Week 0): First inebilizumab administration Visit 2 (Week 2) Visit 3 (Week 4) Visit 4 (Week 12) Visit 5 (Week 24)
- Visit Procedures Visit 1:Laboratory tests (CBC, biochemistry, IgA/IgM/IgG levels, lymphocyte subsets)、MRI (brain/orbital/spinal)、Serum markers (AQP4-IgG, NFL, GFAP)、Clinical assessments (EDSS, Hauser Ambulation Index) Visit 2:Adverse event assessment Laboratory tests (CBC, biochemistry, IgA/IgM/IgG, lymphocyte subsets)、Clinical assessments Visit 3:Adverse event assessment、Clinical assessments Visit 4:Adverse event assessment Laboratory tests (CBC, biochemistry, IgA/IgM/IgG, lymphocyte subsets, serum markers)、Clinical assessments Visit 5:Full repeat of Visit 1 assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inebilizumab with Rapid Steroid Tapering group | Experimental | Drug: Inebilizumab + Rapid Steroid Tapering groupParticipants receive: 1. Acute-phase: Methylprednisolone 1.0g IV daily (Days 1-5) 2. Maintenance-phase: * Day 6: Prednisone 60mg po daily + Inebilizumab 300mg IV * Day 20: Second inebilizumab 300mg IV + Prednisone reduced to 60mg po every other day 3. Steroid tapering schedule:Day 34→30mg EOD → Day 48→15mg EOD → Day 62→10mg EOD → Day 76→5mg EOD → Day 90→Discontinue 4. Long-term: Third inebilizumab 300mg IV at Week 24 |
| Inebilizumab with Standard Steroid Tapering group | Active comparator | Drug: Inebilizumab + Standard Steroid Tapering groupParticipants receive: 1. Acute-phase (Days 1-5):Methylprednisolone 1.0g IV daily 2. Maintenance-phase: * Day 6: Prednisone 60mg po daily +First inebilizumab 300mg IV * Day 20: Second inebilizumab 300mg IV+Continue prednisone 60mg po daily until Day 34 3. Steroid Tapering Schedule: Day 34→60mg EOD → Day 62→30mg EOD → Day 90→15mg EOD → Day 118→10mg EOD → Day 146→5mg EOD → Day 174→Discontinue 4. Long-term: Third inebilizumab 300mg IV at Week 24 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and are AQP4-IgG positive, with a first-attack episode;
- Male or female,age >=18 and <=65 years old;
- EDSS score ≤ 7.5;
- Female subjects of childbearing potential must have a negative pregnancy test result during the screening period and must use effective contraception throughout the study period;
- Voluntarily sign the informed consent form.
Key exclusion criteria (17 listed)
- Laboratory abnormalities include: (white blood cell count < 3×10⁹/L), (neutrophils < 1.5×10⁹/L), (hemoglobin < 85 g/L), (platelet count < 80×10⁹/L), (serum creatinine > 1.5×ULN), (total bilirubin > 1.5×ULN), (AST (GOT) > 3×ULN), (ALT (GPT) > 3×ULN), (alkaline phosphatase > 2×ULN).
- Patients currently suffering from active hepatitis or with a history of severe liver disease are ineligible. Based on the following serological test results for HBsAg, anti-HBc antibodies, and anti-HBs antibodies, there is evidence of hepatitis B virus (HBV) infection: Patients with positive HBsAg should be excluded. For patients with negative HBsAg but positive anti-HBc antibodies, regardless of whether anti-HBs antibodies are positive or negative, HBV-DNA testing is required to determine their status: If HBV-DNA is positive, the patient should be excluded; if HBV-DNA is negative, the patient may be eligible for the trial.
- Patients with other chronic active immune system diseases, or those with stable conditions but requiring glucocorticoid therapy, are excluded, except for neuromyelitis optica spectrum disorder (NMOSD). Examples include rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic immunodeficiency, or drug-induced immunodeficiency. Patients with only positive autoantibodies but without clinical manifestations may be eligible for the trial.
- Pregnant women, breastfeeding women, and patients who plan to conceive during the trial period.
- Allergic reactions: Patients with a history of allergies to contrast agents administered via the parenteral route or to human-derived biological products.
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 |
|---|---|---|
| Inebilizumab + Rapid Steroid Tapering groupAlso: Inebilizumab with rapid glucocorticoid taper groupDrug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-19: 60 mg daily；Day 20: 60 mg every other day (EOD) ；Day 34: 30 mg EOD → Day 48: 15 mg EOD → Day 62: 10 mg EOD → Day 76: 5 mg EOD → Day 90: Discontinue Route: Oral | Drug | Inebilizumab with Rapid Steroid Tapering group |
| Inebilizumab + Standard Steroid Tapering groupAlso: Inebilizumab with standard glucocorticoid taper groupDrug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-34: 60 mg daily;Day 34: 60 mg EOD → Day 62: 30 mg EOD → Day 90: 15 mg EOD → Day 118: 10 mg EOD → Day 146: 5 mg EOD → Day 174:Discontinue; Route: Oral | Drug | Inebilizumab with Standard Steroid Tapering group |
Primary outcome
The change in the average daily dose of corticosteroids between the two groups during the follow-up period compared to randomization (i.e., baseline
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24
Record the corticosteroid dose for patients at randomization (baseline) and during the follow-up period
Time to first clinical relapse
Time frame: From the date of randomization (baseline) to the date of first documented clinical relapse (as defined by protocol criteria), assessed up to 24 weeks.
Accurately document the time of symptom onset in patients.
4 secondary outcomes
The change in EDSS (Expanded Disability Status Scale) score from.
Time frame: Baseline,Week 2, Week 4, Week 12, Week 24
The incidence, severity, and outcomes of adverse events in each group of patients
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24
Area Under the Dose-Time Curve of Corticosteroids (AUDTC)
Time frame: Week 24
The change in the Hauser Walking Index from baseline for each group of patients.
Time frame: Baseline, Week 2, Week 4, Week 12, Week 24
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.
Xu Zhang, Bachelor principal investigator
First Affiliated Hospital of Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Inebilizumab + Rapid Steroid Tapering group and Inebilizumab + Standard Steroid Tapering group in people with Neuromyelitis Optica and Autoimmune Diseases, run by First Affiliated Hospital of Wenzhou Medical University.
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 17 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: opening soon, 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.
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?
Contact Xu Zhang, Bachelor (0086-13587688130, drzhangxu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the average daily dose of corticosteroids between the two groups during the follow-up period compared to randomization (i.e., baseline (time frame: Baseline, Week 2, Week 4, Week 12, Week 24). The study lists 2 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.