Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Slow-tapering glucocorticoids + Inebilizumab
  • Rapid-tapering glucocorticoids + Inebilizumab

Treatment groups

170 Participants
are divided into 2 treatment groups

Locations

This trial has no locations