A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

NCT06212245 | Unknown Phase 4

• 1 other identifier: HS-20091-401
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuromyelitis Optica Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with NMOSD attack determined by the investigator

  The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide.

  Day 1 (Baseline) through Day 197

Secondary Outcomes (4)

• Percentage of participants with NMOSD attack determined by the investigator

  Day 1 (Baseline) through Day 379

• Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score

  Day 1 (Baseline) through Day 379

• Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions

  Day 1 (Baseline) through Day 379

• 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

  Day 1 (Baseline) through Day 379

Study Arms (1)

Inebilizumab

EXPERIMENTAL

Participants will receive IV inebilizumab 300 mg

Drug: Inebilizumab

Interventions

Inebilizumab DRUG

Participants will receive IV inebilizumab 300 mg

Inebilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead
• Horizon Therapeutics Ireland DAC: collaborator

Study Sites (1)

IRB of Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 18, 2024
• Study Start: February 25, 2024
• Primary Completion: December 25, 2024
• Study Completion: June 25, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)