TrialBridgeNCT07132398
Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD
Not Yet Recruiting · Phase 3 · Tianjin Medical University General Hospital · registry updated 2025-08-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
Exclusion
- 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.