NL-OMON53937尚未招募2 期
An Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects with Neuromyelitis Optica Spectrum Disorder - A study of a new drug in children with NMOSD.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •1. Written informed consent and any locally required data privacy authorization
- •obtained from the subject*s legally authorized representative in accordance
- •with regional laws or regulations and the subject*s assent, when applicable,
- •prior to performing any protocol-related procedures.
- •2. Male or female subjects, minimum body weight of 15 kg, age 2 to <18 years at
- •the time of screening.
- •3. Positive serum anti-AQP4-IgG result at screening (verified by the central
- •laboratory) and diagnosed with NMOSD.
- •4. Documented history of one or more NMOSD acute relapses within the last year,
- •or 2 or more NMOSD acute relapses within 2 years prior to screening.
- •5. Female subjects of childbearing potential who are sexually active with a
- •nonsterilized male partner must agree to use a highly effective method of
- •contraception from screening until 6 months after the final dose of
- •investigational product (IP)
- •6. Nonsterilized male subjects who are sexually active with a female partner of
- •childbearing potential must agree to use a male condom from Day 1 until 3
- •months after the final dose of IP.
排除标准
- •1. Any condition that, in the opinion of the Investigator, would interfere with
- •the evaluation or administration of the IP or interpretation of subject safety
- •or study results
- •2. 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 Day 1
- •3. Females who are breastfeeding, pregnant, or who intend to become pregnant at
- •any time from screening until 6 months after the final dose of IP
- •4. Known history of allergy or reaction to any component of the IP formulation
- •or history of anaphylaxis following any biologic therapy
- •5. Evidence of alcohol, drug, or chemical abuse, or a recent history of such
- •abuse <1 year prior to Day 1
- •6. Major surgery within 8 weeks prior to screening
- •7. Spontaneous or induced abortion, still or live birth, or pregnancy <= 4 weeks
- •prior to screening
- •8. Evidence of significant hepatic, renal, or metabolic dysfunction or
- •significant hematological abnormality
- •9. Receipt of rituximab or any experimental B-cell depleting agent within 6
- •months prior to screening unless B-cell counts have returned to >= one-half the
- •10. Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1
- •11. Receipt of particular immunosuppressive therapy within 2 months prior to
- •12. Receipt of natalizumab (Tysabri®) within 6 months prior to Day 1
- •13. Severe drug allergic history or anaphylaxis to 2 or more food products or
- •14. Diagnosed with a concurrent autoimmune disease that is uncontrolled (unless
- •approved by the medical monitor)
- •15. Receipt of any of the following:
- •a. Any live or attenuated vaccine within 4 weeks prior to Day 1
- •b. Bacillus Calmette-Guérin vaccine within one year of screening
- •c. Blood transfusion within 4 weeks prior to screening or during screening
- •16. Clinically significant serious active or chronic viral, bacterial, or
- •fungal infection that requires treatment with anti-infectives, within 2 months
- •prior to Day 1
- •17. Known history of congenital or acquired immunodeficiency that predisposes
- •the subject to infection
- •18. Positive test for chronic hepatitis B infection at screening
- •19. Positive test for hepatitis C virus antibody
- •20. Negative test for varicella zoster virus (VZV)-IgG
- •21. History of cancer, apart from squamous cell or basal cell carcinoma of the
- •skin treated with documented success of curative therapy > 3 months prior to
- •22. History of active or latent tuberculosis
- •23. For subjects who may undergo MRI scans: Unable to undergo an MRI scan (eg,
- •hypersensitivity to Gd containing MRI contrast agents, implanted pacemakers,
- •defibrillators, or other metallic objects on or inside the body that limit
- •performing MRI scans), or unable to tolerate or comply with the MRI procedure.
研究者
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