Neuromyelitis Optica (NMO)Phase 3STARGlu-NMONCT07132398
Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD
A Phase 3 study testing Slow-tapering glucocorticoids + Inebilizumab and Rapid-tapering glucocorticoids + Inebilizumab in people with Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Tianjin Medical University General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica (NMO), Neuromyelitis Optica Spectrum Disorders (NMOSD)
- What is being tested?
- Slow-tapering glucocorticoids + Inebilizumab and Rapid-tapering glucocorticoids + Inebilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- Slow-tapering glucocorticoids + Inebilizumab, Rapid-tapering glucocorticoids + Inebilizumab
- Keywords
- NMO, NMOSD, Inebilizumab, Glucocorticoids
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-tapering glucocorticoids + InebilizumabDrug
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 + InebilizumabDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Slow-tapering glucocorticoids + Inebilizumab arm | Active comparator | Not described Receives: Drug: Slow-tapering glucocorticoids + Inebilizumab |
| Rapid-tapering glucocorticoids + Inebilizumab arm | Active comparator | Not described Receives: Drug: Rapid-tapering glucocorticoids + Inebilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
First adjudicated relapse event within 54 weeks
Measured: Baseline, 54 Weeks
Secondary outcomes (28)
Change in Expanded Disability Status Scale (EDSS) score from baseline at 54 weeks
Measured: Baseline, 54 Weeks
Change in Low-contrast Visual Acuity (LCVA) from baseline at 54 weeks
Measured: Baseline, 54 Weeks
Change in Timed 25-Foot Walk (T25-FW) test from baseline at 54 weeks
Measured: Baseline, 54 Weeks
Change in Expanded Disability Status Scale (EDSS) score from baseline at 106 weeks
Measured: Baseline, 106 Weeks
Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks
Measured: Baseline, 106 Weeks
Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks
Measured: Baseline, 106 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks
Measured: Baseline, 54 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks
Measured: Baseline, 54 Weeks
Change in serum AQP4-IgG titer at 54 weeks
Measured: Baseline, 54 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks
Measured: Baseline, 106 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks
Measured: Baseline, 106 Weeks
Change in serum AQP4-IgG titer at 106 weeks
Measured: Baseline, 106 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 54 weeks
Measured: Baseline, 54 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 106 weeks
Measured: Baseline, 106 Weeks
Change in Quality of Life (QoL) score from baseline at 54 weeks
Measured: Baseline, 54 Weeks
Change in Quality of Life (QoL) score from baseline at 106 weeks
Measured: Baseline, 106 Weeks
Proportion of Relapse-free Participants at 54 weeks
Measured: Baseline, 54 Weeks
Proportion of Relapse-free Participants at 106 weeks
Measured: Baseline, 106 Weeks
Percentage of patients in glucocorticoid-free remission between 54 and 106 weeks
Measured: 54 Weeks, 106 Weeks
Annualized Relapse Rate (ARR) at 54 weeks
Measured: Baseline, 54 Weeks
Annualized Relapse Rate (ARR) at 106 weeks
Measured: Baseline, 106 Weeks
Daily and acumulate dose of glucocorticoids at relapse before 54 weeks
Measured: Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 54 weeks
Measured: Baseline, 54 Weeks
Immunoglobulin levels at 54 weeks
Measured: Baseline, 54 Weeks
Pelvic X-ray at 54 weeks
Measured: Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 106 weeks
Measured: Baseline, 106 Weeks
Immunoglobulin levels at 106 weeks
Measured: Baseline, 106 Weeks
Pelvic X-ray at 106 weeks
Measured: Baseline, 106 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica (NMO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Sheng Yang, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132398
- Sponsor's protocol ID
- YG20250610
- Acronym
- STARGlu-NMO
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07132398
- Acronym / sponsor ID
- STARGlu-NMO / YG20250610
- Keywords
- NMO, NMOSD, Inebilizumab, Glucocorticoids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow-tapering glucocorticoids + Inebilizumab arm | Active comparator | Drug: Slow-tapering glucocorticoids + Inebilizumab |
| Rapid-tapering glucocorticoids + Inebilizumab arm | Active comparator | Drug: Rapid-tapering glucocorticoids + Inebilizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-tapering glucocorticoids + InebilizumabSlow-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). | Drug | Slow-tapering glucocorticoids + Inebilizumab arm |
| Rapid-tapering glucocorticoids + InebilizumabRapid-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). | Drug | Rapid-tapering glucocorticoids + Inebilizumab arm |
Primary outcome
First adjudicated relapse event within 54 weeks
Time frame: Baseline, 54 Weeks
28 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
Change in Low-contrast Visual Acuity (LCVA) from baseline at 106 weeks
Time frame: Baseline, 106 Weeks
Change in Timed 25-Foot Walk (T25-FW) test from baseline at 106 weeks
Time frame: Baseline, 106 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 54 weeks
Time frame: Baseline, 54 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 54 weeks
Time frame: Baseline, 54 Weeks
Change in serum AQP4-IgG titer at 54 weeks
Time frame: Baseline, 54 Weeks
Change in serum Neurofilament Light chain (sNfL) levels at 106 weeks
Time frame: Baseline, 106 Weeks
Change in serum Glial Fibrillary Acidic Protein (sGFAP) levels at 106 weeks
Time frame: Baseline, 106 Weeks
Change in serum AQP4-IgG titer at 106 weeks
Time frame: Baseline, 106 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 54 weeks
Time frame: Baseline, 54 Weeks
Change in Visual Analogue Scale (VAS) score from baseline at 106 weeks
Time frame: Baseline, 106 Weeks
Change in Quality of Life (QoL) score from baseline at 54 weeks
Time frame: Baseline, 54 Weeks
Change in Quality of Life (QoL) score from baseline at 106 weeks
Time frame: Baseline, 106 Weeks
Proportion of Relapse-free Participants at 54 weeks
Time frame: Baseline, 54 Weeks
Proportion of Relapse-free Participants at 106 weeks
Time frame: Baseline, 106 Weeks
Percentage of patients in glucocorticoid-free remission between 54 and 106 weeks
Time frame: 54 Weeks, 106 Weeks
Annualized Relapse Rate (ARR) at 54 weeks
Time frame: Baseline, 54 Weeks
Annualized Relapse Rate (ARR) at 106 weeks
Time frame: Baseline, 106 Weeks
Daily and acumulate dose of glucocorticoids at relapse before 54 weeks
Time frame: Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 54 weeks
Time frame: Baseline, 54 Weeks
Immunoglobulin levels at 54 weeks
Time frame: Baseline, 54 Weeks
Pelvic X-ray at 54 weeks
Time frame: Baseline, 54 Weeks
Adverse events (AEs) and Serious AEs (SAEs) at 106 weeks
Time frame: Baseline, 106 Weeks
Immunoglobulin levels at 106 weeks
Time frame: Baseline, 106 Weeks
Pelvic X-ray at 106 weeks
Time frame: Baseline, 106 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Slow-tapering glucocorticoids + Inebilizumab and Rapid-tapering glucocorticoids + Inebilizumab in people with Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Tianjin Medical University General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Sheng Yang, M.D., Ph.D. (+86-022-60814587, cyang01@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First adjudicated relapse event within 54 weeks (time frame: Baseline, 54 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.