Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT07159893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inectolizumab With Steroid Optimization in Newly Treated NMOSD
Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Organization:
Study Overview
Official Title:
Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: