Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD (STARGlu-NMO)

August 12, 2025 updated by: Chun-Sheng Yang, Tianjin Medical University General Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chun-Sheng Yang, M.D., Ph.D.
  • Phone Number: +86-022-60814587
  • Email: cyang01@tmu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ability and willingness to provide written informed consent and comply with the requirements of the study protocol.
  2. Age ≥18 years, regardless of sex.
  3. Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) criteria.
  4. Serum AQP4-IgG antibody positivity at screening.
  5. 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:

  1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
  2. Subjects with any serious acute, chronic, or recurrent infections (e.g., pneumonia, pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.).
  3. Carriers of hepatitis B virus, or patients with chronic active hepatitis B or C, other chronic liver diseases, or HIV infection.
  4. 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).
  5. Active malignancy.
  6. Severe immunodeficiency.
  7. 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.
  8. Receipt of other investigational treatments within 30 days prior to initiation of baseline treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Slow-tapering glucocorticoids + Inebilizumab arm
Drug: Slow-tapering glucocorticoids + Inebilizumab
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).
Active Comparator: Rapid-tapering glucocorticoids + Inebilizumab arm
Drug: Rapid-tapering glucocorticoids + Inebilizumab
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
First adjudicated relapse event within 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Expanded Disability Status Scale (EDSS) score from baseline at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in Low-contrast Visual Acuity (LCVA) from baseline at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in Timed 25-Foot Walk (T25-FW) test from baseline at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in Expanded Disability Status Scale (EDSS) score from baseline at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in serum AQP4-IgG titer at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Change in serum AQP4-IgG titer at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Change in Quality of Life (QoL) score from baseline at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Change in Quality of Life (QoL) score from baseline at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Proportion of Relapse-free Participants at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Proportion of Relapse-free Participants at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Percentage of patients in glucocorticoid-free remission between 54 and 106 weeks
Time Frame: 54 Weeks, 106 Weeks
54 Weeks, 106 Weeks
Annualized Relapse Rate (ARR) at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Annualized Relapse Rate (ARR) at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Daily and acumulate dose of glucocorticoids at relapse before 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Immunoglobulin levels at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Pelvic X-ray at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Immunoglobulin levels at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks
Pelvic X-ray at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Lymphocyte Subpopulation Monitoring at 54 weeks
Time Frame: Baseline, 54 Weeks
Baseline, 54 Weeks
Lymphocyte Subpopulation Monitoring at 106 weeks
Time Frame: Baseline, 106 Weeks
Baseline, 106 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YG20250610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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