Inectolizumab With Steroid Optimization in Newly Treated NMOSD

NCT07159893 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-076
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Neuromyelitis Optica; Autoimmune Diseases; Demyelinating Autoimmune Diseases, CNS

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline, Week 2, Week 4, Week 12, Week 24

• Time to first clinical relapse

  Accurately document the time of symptom onset in patients.

  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.

  Baseline,Week 2, Week 4, Week 12, Week 24

• The incidence, severity, and outcomes of adverse events in each group of patients

  Baseline, Week 2, Week 4, Week 12, Week 24

• Area Under the Dose-Time Curve of Corticosteroids (AUDTC)

  Week 24

• The change in the Hauser Walking Index from baseline for each group of patients.

  Baseline, Week 2, Week 4, Week 12, Week 24

Study Arms (2)

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

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

Drug: Inebilizumab + Standard Steroid Tapering group

Interventions

Inebilizumab + Rapid Steroid Tapering group DRUG

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

Also known as: Inebilizumab with rapid glucocorticoid taper group

Inebilizumab with Rapid Steroid Tapering group

Inebilizumab + Standard Steroid Tapering group DRUG

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

Also known as: Inebilizumab with standard glucocorticoid taper group

Inebilizumab with Standard Steroid Tapering group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Neuromyelitis Optica; Autoimmune Diseases; Demyelinating Autoimmune Diseases, CNS

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Xu Zhang, Bachelor

  First Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Zhang, Bachelor

CONTACT

0086-13587688130; drzhangxu@live.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share