Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD (STARGlu-NMO)

Tianjin Medical University

Status and phase: Not yet enrolling; Phase 3

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

Treatments: Drug: Rapid-tapering glucocorticoids + Inebilizumab; Drug: Slow-tapering glucocorticoids + Inebilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07132398

YG20250610

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Slow-tapering glucocorticoids + Inebilizumab arm

Active Comparator group

Treatment:

Drug: Slow-tapering glucocorticoids + Inebilizumab

Rapid-tapering glucocorticoids + Inebilizumab arm

Active Comparator group

Treatment:

Drug: Rapid-tapering glucocorticoids + Inebilizumab