Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

Официальное название

The Efficacy of Slow - Tapering Versus Rapid - Tapering Glucocorticoid Strategies in Preventing Relapses of Neuromyelitis Optica Spectrum Disorder (NMOSD) When Combined With Inebilizumab: A Multicenter, Open - Label, Randomized Parallel - Controlled Clinical Trial

Обзор

Neuromyelitis optica spectrum disorder (NMOSD) is a central nervous system autoimmune condition mainly involving the spinal cord, optic nerves, and area postrema. The anti-aquaporin-4 (AQP4)-Immunoglobulin G (IgG) is a specific biomarker for NMOSD. Glucocorticoids(GCs) are used as first-line treatment for NMOSD. Oral glucocorticoids tapering is always suggested following the pused therapy in the maintenance phase. Inebilizumab, a humanized monoclonal antibody targeting CD19, has been proven effective in preventing NMOSD relapses. This study aims to evaluate and compare the efficacy and differences between glucocorticoids slow-tapering and rapid-tapering strategies combined with inebilizumab in preventing relapses in AQP4-IgG-seropositive NMOSD patients following an acute attack, with the goal of determining the optimal approach to steroid tapering and discontinuation after initiation of inebilizumab.

Вмешательства

• Препарат Slow-tapering glucocorticoids + Inebilizumab
  Slow-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab. The prednisone dose will be tapered as follows: a reduction of 5 mg every 2 weeks until reaching 20 mg/day(Week 16); thereafter, a reduction of 5 mg every 4 weeks until discontinuation (a total duration of 32 wee
• Препарат Rapid-tapering glucocorticoids + Inebilizumab
  Rapid-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab, with a tapering schedule of 5 mg reduction per week until discontinuation (a total duration of 12 weeks for combined inebilizumab and glucocorticoids therapy).

Первичные конечные точки

• First adjudicated relapse event within 54 weeks [Срок оценки: Baseline, 54 Weeks]

Вторичные конечные точки (12)

• Change in Expanded Disability Status Scale (EDSS) score from baseline at 54 weeks [Срок оценки: Baseline, 54 Weeks]
• Change in Low-contrast Visual Acuity (LCVA) from baseline at 54 weeks [Срок оценки: Baseline, 54 Weeks]
• Change in Timed 25-Foot Walk (T25-FW) test from baseline at 54 weeks [Срок оценки: Baseline, 54 Weeks]
• Change in Expanded Disability Status Scale (EDSS) score from baseline at 106 weeks [Срок оценки: Baseline, 106 Weeks]
• Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks [Срок оценки: Baseline, 106 Weeks]
• Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks [Срок оценки: Baseline, 106 Weeks]
• Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks [Срок оценки: Baseline, 54 Weeks]
• Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks [Срок оценки: Baseline, 54 Weeks]
• Change in serum AQP4-IgG titer at 54 weeks [Срок оценки: Baseline, 54 Weeks]
• Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks [Срок оценки: Baseline, 106 Weeks]
• Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks [Срок оценки: Baseline, 106 Weeks]
• Change in serum AQP4-IgG titer at 106 weeks [Срок оценки: Baseline, 106 Weeks]

Критерии участия

Критерии включения

• Ability and willingness to provide written informed consent and comply with the requirements of the study protocol.
• Age ≥18 years, regardless of sex.
• Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) criteria.
• Serum AQP4-IgG antibody positivity at screening.
• An acute clinical attack (including the first attack) within 1 month before screening. After the acute attack was treated with high-dose corticosteroids, the current oral prednisone dose was reduced to 60 mg per day.

Критерии исключения

• Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
• Subjects with any serious acute, chronic, or recurrent infections (e.g., pneumonia, pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.).
• Carriers of hepatitis B virus, or patients with chronic active hepatitis B or C, other chronic liver diseases, or HIV infection.
• Abnormal liver function (ALT/AST >2 times the upper limit of normal); moderate to severe renal impairment (glomerular filtration rate <60 mL/min/1.73 m²).
• Active malignancy.
• Severe immunodeficiency.
• Receipt of any B-cell depleting therapy within 6 months prior to initiation of baseline treatment, with B-cell counts below the lower limit of normal.
• Receipt of other investigational treatments within 30 days prior to initiation of baseline treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07132398 · YG20250610

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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