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NCT Number: NCT07132398

Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

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.

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Key information

Conditions

Neuromyelitis Optica (NMO) Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorders (NMOSD) Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. First adjudicated relapse event within 54 weeks

    Time frame: Baseline, 54 Weeks

Secondary outcomes

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

    Time frame: Baseline, 54 Weeks

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

    Time frame: Baseline, 54 Weeks

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

    Time frame: Baseline, 54 Weeks

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

    Time frame: Baseline, 106 Weeks

  5. Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks

    Time frame: Baseline, 106 Weeks

  6. Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks

    Time frame: Baseline, 106 Weeks

  7. Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks

    Time frame: Baseline, 54 Weeks

  8. Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks

    Time frame: Baseline, 54 Weeks

  9. Change in serum AQP4-IgG titer at 54 weeks

    Time frame: Baseline, 54 Weeks

  10. Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks

    Time frame: Baseline, 106 Weeks

  11. Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks

    Time frame: Baseline, 106 Weeks

  12. Change in serum AQP4-IgG titer at 106 weeks

    Time frame: Baseline, 106 Weeks

  13. Change in Visual Analogue Scale (VAS) score from baseline at 54 weeks

    Time frame: Baseline, 54 Weeks

  14. Change in Visual Analogue Scale (VAS) score from baseline at 106 weeks

    Time frame: Baseline, 106 Weeks

  15. Change in Quality of Life (QoL) score from baseline at 54 weeks

    Time frame: Baseline, 54 Weeks

  16. Change in Quality of Life (QoL) score from baseline at 106 weeks

    Time frame: Baseline, 106 Weeks

  17. Proportion of Relapse-free Participants at 54 weeks

    Time frame: Baseline, 54 Weeks

  18. Proportion of Relapse-free Participants at 106 weeks

    Time frame: Baseline, 106 Weeks

  19. Percentage of patients in glucocorticoid-free remission between 54 and 106 weeks

    Time frame: 54 Weeks, 106 Weeks

  20. Annualized Relapse Rate (ARR) at 54 weeks

    Time frame: Baseline, 54 Weeks

  21. Annualized Relapse Rate (ARR) at 106 weeks

    Time frame: Baseline, 106 Weeks

  22. Daily and acumulate dose of glucocorticoids at relapse before 54 weeks

    Time frame: Baseline, 54 Weeks

  23. Adverse events (AEs) and Serious AEs (SAEs) at 54 weeks

    Time frame: Baseline, 54 Weeks

  24. Immunoglobulin levels at 54 weeks

    Time frame: Baseline, 54 Weeks

  25. Pelvic X-ray at 54 weeks

    Time frame: Baseline, 54 Weeks

  26. Adverse events (AEs) and Serious AEs (SAEs) at 106 weeks

    Time frame: Baseline, 106 Weeks

  27. Immunoglobulin levels at 106 weeks

    Time frame: Baseline, 106 Weeks

  28. Pelvic X-ray at 106 weeks

    Time frame: Baseline, 106 Weeks

Other outcomes

  1. Lymphocyte Subpopulation Monitoring at 54 weeks

    Time frame: Baseline, 54 Weeks

  2. Lymphocyte Subpopulation Monitoring at 106 weeks

    Time frame: Baseline, 106 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Sheng Yang, M.D., Ph.D.

CONTACT

[email protected]

+86-022-60814587

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

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

Acronym: STARGlu-NMO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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