NCT07132398Not yet recruitingPhase 3
Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD
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
Source: ClinicalTrials.gov · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 17 Jun 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Tianjin Medical University General Hospital
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT07132398
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 170
- From 1 Sept 2025 to the primary completion date, 31 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of other investigational treatments within 30 days prior to initiation of baseline treatment.
Other illness
- 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.
- Active malignancy.
Lab values
- 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).
- 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.
Other
- Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
- Severe immunodeficiency.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.