Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

ConditionsNeuromyelitis Optica (NMO)Neuromyelitis Optica Spectrum Disorders (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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).
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).

Treatment groups

170 Participants

are divided into 2 treatment groups

Group A: Slow-tapering glucocorticoids + Inebilizumab armActive comparator 1 intervention

Group B: Rapid-tapering glucocorticoids + Inebilizumab armActive comparator 1 intervention

Trial outcomes

Primary outcomes

First adjudicated relapse event within 54 weeks

Time frame

Baseline, 54 Weeks

Secondary outcomes

Change in Expanded Disability Status Scale (EDSS) score from baseline at 54 weeks

Time frame

Baseline, 54 Weeks

Change in Low-contrast Visual Acuity (LCVA) from baseline at 54 weeks

Time frame

Baseline, 54 Weeks

Change in Timed 25-Foot Walk (T25-FW) test from baseline at 54 weeks

Time frame

Baseline, 54 Weeks

Change in Expanded Disability Status Scale (EDSS) score from baseline at 106 weeks

Time frame

Baseline, 106 Weeks

Other outcomes

Lymphocyte Subpopulation Monitoring at 54 weeks

Time frame

Baseline, 54 Weeks

Lymphocyte Subpopulation Monitoring at 106 weeks

Time frame

Baseline, 106 Weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University General Hospital

Lead sponsor

Source ClinicalTrials.gov

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