Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

NCT ID: NCT07132398

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-08-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slow-tapering glucocorticoids + Inebilizumab arm

Group Type: ACTIVE_COMPARATOR

Slow-tapering glucocorticoids + Inebilizumab

Intervention Type: 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).

Rapid-tapering glucocorticoids + Inebilizumab arm

Group Type: ACTIVE_COMPARATOR

Rapid-tapering glucocorticoids + Inebilizumab

Intervention Type: 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).

Interventions

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 weeks for combined inebilizumab and glucocorticoids therapy).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chun-Sheng Yang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

cyang01@tmu.edu.cn

+86-022-60814587

Other Identifiers

YG20250610

Identifier Type: -

Identifier Source: org_study_id