Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD (NCT07132398) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD
170 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First adjudicated relapse event within 54 weeks
Timeframe: Baseline, 54 Weeks
Trial details
NCT IDNCT07132398
SponsorTianjin Medical University General Hospital
. 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.