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Clinical Trials/NCT07132398
NCT07132398Not yet recruitingPhase 3

The Efficacy of Slow - Tapering Versus Rapid - Tapering Glucocorticoid Strategies in Preventing Relapses of Neuromyelitis Optica Spectrum Disorder (NMOSD) When Combined With Inebilizumab: A Multicenter, Open - Label, Randomized Parallel - Controlled Clinical Trial

Tianjin Medical University General Hospital0 sites170 target enrollmentStarted: September 1, 2025Last updated:
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Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
170
Primary Endpoint
First adjudicated relapse event within 54 weeks
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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.
  • •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.
  • •Receipt of other investigational treatments within 30 days prior to initiation of baseline treatment.

Arms & Interventions

Slow-tapering glucocorticoids + Inebilizumab arm

Active Comparator

Intervention: Slow-tapering glucocorticoids + Inebilizumab (Drug)

Rapid-tapering glucocorticoids + Inebilizumab arm

Active Comparator

Intervention: Rapid-tapering glucocorticoids + Inebilizumab (Drug)

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(Baseline, 54 Weeks)
  • Change in Low-contrast Visual Acuity (LCVA) from baseline at 54 weeks(Baseline, 54 Weeks)
  • Change in Timed 25-Foot Walk (T25-FW) test from baseline at 54 weeks(Baseline, 54 Weeks)
  • Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks(Baseline, 106 Weeks)
  • Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks(Baseline, 54 Weeks)
  • Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks(Baseline, 54 Weeks)
  • Change in serum AQP4-IgG titer at 54 weeks(Baseline, 54 Weeks)
  • Change in serum AQP4-IgG titer at 106 weeks(Baseline, 106 Weeks)
  • Change in Visual Analogue Scale (VAS) score from baseline at 54 weeks(Baseline, 54 Weeks)
  • Change in Quality of Life (QoL) score from baseline at 54 weeks(Baseline, 54 Weeks)
  • Change in Expanded Disability Status Scale (EDSS) score from baseline at 106 weeks(Baseline, 106 Weeks)
  • Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks(Baseline, 106 Weeks)
  • Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks(Baseline, 106 Weeks)
  • Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks(Baseline, 106 Weeks)
  • Change in Visual Analogue Scale (VAS) score from baseline at 106 weeks(Baseline, 106 Weeks)
  • Change in Quality of Life (QoL) score from baseline at 106 weeks(Baseline, 106 Weeks)
  • Proportion of Relapse-free Participants at 54 weeks(Baseline, 54 Weeks)
  • Proportion of Relapse-free Participants at 106 weeks(Baseline, 106 Weeks)
  • Percentage of patients in glucocorticoid-free remission between 54 and 106 weeks(54 Weeks, 106 Weeks)
  • Annualized Relapse Rate (ARR) at 54 weeks(Baseline, 54 Weeks)
  • Annualized Relapse Rate (ARR) at 106 weeks(Baseline, 106 Weeks)
  • Daily and acumulate dose of glucocorticoids at relapse before 54 weeks(Baseline, 54 Weeks)
  • Adverse events (AEs) and Serious AEs (SAEs) at 54 weeks(Baseline, 54 Weeks)
  • Adverse events (AEs) and Serious AEs (SAEs) at 106 weeks(Baseline, 106 Weeks)
  • Immunoglobulin levels at 106 weeks(Baseline, 106 Weeks)
  • Pelvic X-ray at 106 weeks(Baseline, 106 Weeks)
  • Immunoglobulin levels at 54 weeks(Baseline, 54 Weeks)
  • Pelvic X-ray at 54 weeks(Baseline, 54 Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chun-Sheng Yang

Clinical Professor

Tianjin Medical University General Hospital

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