Inectolizumab With Steroid Optimization in Newly Treated NMOSD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFirst Affiliated Hospital of Wenzhou Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Inebilizumab + Rapid Steroid Tapering group
DrugDrug 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 group
DrugDrug 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
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Inebilizumab with Rapid Steroid Tapering groupExperimental treatment 1 intervention
Group B: Inebilizumab with Standard Steroid Tapering groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, Week 2, Week 4, Week 12, Week 242
Time to first clinical relapse
Accurately document the time of symptom onset in patients.
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.Secondary outcomes
1
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.
Time frame
Baseline,Week 2, Week 4, Week 12, Week 242
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.
Time frame
Baseline, Week 2, Week 4, Week 12, Week 243
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.
Time frame
Week 244
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.
Time frame
Baseline, Week 2, Week 4, Week 12, Week 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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