Clinical trial NCT06212245: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Official title: An Open-label Single-arm Clinical Study to Assess the Efficacy and Safety of Inebilizumab in Chinese Adult Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Neuromyelitis Optica Spectrum Disorders
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
Collaborators: name: Horizon Therapeutics Ireland DAC
First posted: 2024-01-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of Inebilizumab in Chinese adult patients with neuromyelitis optica spectrum disorders.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Patients who have received any of the following treatments at any time prior to randomization:

  1. Monoclonal antibodies against CD52: such as alemtuzumab, etc.
  2. Total lymphoid irradiation
  3. Bone marrow transplant
  4. 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.

Primary outcomes:
measure: Percentage of participants with NMOSD attack determined by the investigator
timeFrame: Day 1 (Baseline) through Day 197
Secondary outcomes:
measure: Percentage of participants with NMOSD attack determined by the investigator
timeFrame: Day 1 (Baseline) through Day 379
measure: Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score
timeFrame: Day 1 (Baseline) through Day 379
measure: Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions
timeFrame: Day 1 (Baseline) through Day 379
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Laboratory measurements as well as their changes or shift as assessed by CTCAE v5.0
timeFrame: Day 1 (Baseline) through Day 379
Other outcomes:
Locations:
city: Beijing
country: China
facility: IRB of Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: