Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

NCT07132398 | Not Yet Recruiting Phase 3

• 1 other identifier: YG20250610
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuromyelitis Optica (NMO); Neuromyelitis Optica Spectrum Disorders (NMOSD)

Keywords

NMO; NMOSD; Inebilizumab; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• First adjudicated relapse event within 54 weeks

  Baseline, 54 Weeks

Secondary Outcomes (28)

• 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 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

Other Outcomes (2)

• Lymphocyte Subpopulation Monitoring at 54 weeks

  Baseline, 54 Weeks

• Lymphocyte Subpopulation Monitoring at 106 weeks

  Baseline, 106 Weeks

Study Arms (2)

Slow-tapering glucocorticoids + Inebilizumab arm

ACTIVE COMPARATOR

Drug: Slow-tapering glucocorticoids + Inebilizumab

Rapid-tapering glucocorticoids + Inebilizumab arm

ACTIVE COMPARATOR

Drug: Rapid-tapering glucocorticoids + Inebilizumab

Interventions

Slow-tapering glucocorticoids + Inebilizumab DRUG

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 weeks for combined inebilizumab and glucocorticoids therapy).

Slow-tapering glucocorticoids + Inebilizumab arm

Rapid-tapering glucocorticoids + Inebilizumab DRUG

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).

Rapid-tapering glucocorticoids + Inebilizumab arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chun-Sheng Yang, M.D., Ph.D.

CONTACT

+86-022-60814587; cyang01@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share