Status:
NOT_YET_RECRUITING
A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
Hansoh BioMedical R&D Company
Collaborating Sponsors:
Horizon Therapeutics Ireland DAC
Conditions:
Neuromyelitis Optica Spectrum Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of Inebilizumab in Chinese adult patients with neuromyelitis optica spectrum disorders.
Eligibility Criteria
Inclusion
- Patients who have comprehensive understanding of the study content, process and possible adverse reactions, and sign the informed consent forms voluntarily
- Men and women 18 years or older
- Patients with NMOSD diagnosed according to the definition in the Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders in China
- Patients with positive serum anti-AQP4-IgG results at screening
- A documented history of one or more NMOSD acute relapses that required rescue therapy within the last year, or 2 or more NMOSD acute relapses that required rescue therapy within 2 years prior to screening
- Patients with EDSS score of ≤ 7.5 points
- Patients who and whose sexual partner agree to take highly effective method of contraception from screening
Exclusion
- Patients who have received any of the following treatments at any time prior to randomization:
- Monoclonal antibodies against CD52: such as alemtuzumab, etc.
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
- Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
- Patients who have received intravenous injection of immunoglobulin (IVIG) within 1 month prior to randomization;
- Patients who have received immunosuppressant therapy (e.g., cyclophosphamide, methotrexate, mitoxantrone, ciclosporin A, etc.) and biologics (satralizumab, natalizumab, tocilizumab, eculizumab, etc.) within 3 months or 5 half-lives of such drugs (whichever is longer) before randomization;
- Any concomitant disease other than NMOSD that required treatment with oral or IV steroids at doses \> 20 mg/day for \> 21 days within the 6 months prior to screening;
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to enrollment;
- Severe drug allergic history or anaphylaxis to two or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid); Known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy;
- Patients with evidence of alcohol, drug, or chemical abuse, or with history of such abuse within 1 year prior to randomization;
- Female patients who are lactating or pregnant, or plan to become pregnant at any time from signing the informed consent through the study plus 6 months following last dose of investigational product;
- Patients with clinically significant serious active or chronic viral infection, or bacterial infection within 60 days prior to randomization, which requires treatment with anti-infective agents or hospitalization, or might pose an additional risk to the patient in the opinion of the investigator;
- Patients with known history or underlying disease of primary immunodeficiency (congenital or acquired), such as human immunodeficiency virus (HIV) infection or splenectomy, which predisposes the patient to infection;
- Confirmed positive serology results of hepatitis B/C at screening
- Patients with history of malignancy, except squamous or basal cell carcinoma of skin that has been successfully treated with documented success of curative therapy \> 3 months prior to randomization;
- Any other conditions that, in the opinion of the investigator, are not suitable for participating in the clinical study.
Key Trial Info
Start Date :
February 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06212245
Start Date
February 25 2024
End Date
June 25 2025
Last Update
January 18 2024
Active Locations (1)
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1
IRB of Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000