EUCTR2021-003528-33-SE进行中（未招募）1 期
An Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects with Neuromyelitis Optica Spectrum Disorder
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- 性别
- All
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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 LLN
- •10. Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1
- •11. Receipt of particular immunosuppressive therapy within 2 months prior to Day 1
- •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 medicine
- •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 Day 1
- •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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