Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

Not Applicable

Not yet recruiting

• Conditions: Neuromyelitis Optica (NMO); Neuromyelitis Optica Spectrum Disorders (NMOSD)
• Interventions: Drug: Slow-tapering glucocorticoids + Inebilizumab; Drug: Rapid-tapering glucocorticoids + Inebilizumab

• Registration Number: NCT07132398
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-17
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-09-01
• Primary Completion: 2027-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Ability and willingness to provide written informed consent and comply with the requirements of the study protocol.
2. Age ≥18 years, regardless of sex.
3. Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) criteria.
4. Serum AQP4-IgG antibody positivity at screening.
5. 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.

Exclusion Criteria

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
2. Subjects with any serious acute, chronic, or recurrent infections (e.g., pneumonia, pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.).
3. Carriers of hepatitis B virus, or patients with chronic active hepatitis B or C, other chronic liver diseases, or HIV infection.
4. 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).
5. Active malignancy.
6. Severe immunodeficiency.
7. 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.
8. Receipt of other investigational treatments within 30 days prior to initiation of baseline treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow-tapering glucocorticoids + Inebilizumab arm	Slow-tapering glucocorticoids + Inebilizumab	-
Rapid-tapering glucocorticoids + Inebilizumab arm	Rapid-tapering glucocorticoids + Inebilizumab	-

Primary Outcome Measures

Name	Time	Method
First adjudicated relapse event within 54 weeks	Baseline, 54 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in Expanded Disability Status Scale (EDSS) score from baseline at 54 weeks	Baseline, 54 Weeks
Change in Low-contrast Visual Acuity (LCVA) from baseline at 54 weeks	Baseline, 54 Weeks
Change in Timed 25-Foot Walk (T25-FW) test from baseline at 54 weeks	Baseline, 54 Weeks
Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks	Baseline, 106 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks	Baseline, 54 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks	Baseline, 54 Weeks
Change in serum AQP4-IgG titer at 54 weeks	Baseline, 54 Weeks
Change in serum AQP4-IgG titer at 106 weeks	Baseline, 106 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 54 weeks	Baseline, 54 Weeks
Change in Quality of Life (QoL) score from baseline at 54 weeks	Baseline, 54 Weeks
Change in Expanded Disability Status Scale (EDSS) score from baseline at 106 weeks	Baseline, 106 Weeks
Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks	Baseline, 106 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks	Baseline, 106 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks	Baseline, 106 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 106 weeks	Baseline, 106 Weeks
Change in Quality of Life (QoL) score from baseline at 106 weeks	Baseline, 106 Weeks
Proportion of Relapse-free Participants at 54 weeks	Baseline, 54 Weeks
Proportion of Relapse-free Participants at 106 weeks	Baseline, 106 Weeks
Percentage of patients in glucocorticoid-free remission between 54 and 106 weeks	54 Weeks, 106 Weeks
Annualized Relapse Rate (ARR) at 54 weeks	Baseline, 54 Weeks
Annualized Relapse Rate (ARR) at 106 weeks	Baseline, 106 Weeks
Daily and acumulate dose of glucocorticoids at relapse before 54 weeks	Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 54 weeks	Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 106 weeks	Baseline, 106 Weeks
Immunoglobulin levels at 106 weeks	Baseline, 106 Weeks
Pelvic X-ray at 106 weeks	Baseline, 106 Weeks
Immunoglobulin levels at 54 weeks	Baseline, 54 Weeks
Pelvic X-ray at 54 weeks	Baseline, 54 Weeks