EUCTR2017-001334-26-IT进行中（未招募）1 期
A multicenter, open-label, long-term safety study of AR101 characterized oral desensitization immunotherapy in subjects who participated in a prior AR101 study - Long-term Safety Study of AR101 CODIT™
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all the following criteria to be eligible:
- •1. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future
- •clinical study that identifies ARC008 as a follow-on study option in the protocol
- •2. Written informed consent from the subject or guardian/parent (or both parents where required by local authorities) in accordance with local institutional review board (IRB)/ethics committee (EC) guidelines
- •3. Written assent from the subject as required by local IRB/EC guidelines
- •4. Use of effective birth control by sexually active females of childbearing potential (Section 5.9.4)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who meet any of the following criteria are not eligible:
- •1. Did not complete a minimum of 3 months of AR101 Maintenance in the parent study if subject was assigned to AR101 in that study, except for
- •subjects in ARC004 who did not tolerate the nondaily AR101 dosing regimen, subjects in ARC007, or unless specified otherwise in the parent study
- •2. For subjects treated with AR101 in the parent study requiring a food challenge, failure to successfully consume at least the 300 mg single dose (443 mg cumulative dose) of peanut protein at parent study's exit food challenge
- •3. History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or
- •requiring a change in chronic therapeutic regimen, including malignancies occurring within 5 years prior to Screening and clinically active autoimmune diseases
- •4. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
- •5. Developed a clinically significant change in health status during the parent study that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
- •6. Taking a prohibited medication, as listed in Section 5.9.5
- •7. Currently participating in any other interventional clinical study other than the Aimmune parent study
- •8. Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or
- •unless allowed in the parent study
- •9. Subject is living in the same household or is a dependent of sponsor employees and/or site staff involved in conducting this study, except for
- •subjects originating from Aimmune Studies ARC002, ARC004, ARC007, ARC010, and ARC011
- •10. Currently in the build-up phase of immunotherapy for any non-food allergen
- •11. Hypersensitivity to epinephrine or hypersensitivity to any of the excipients in the IP
- •12. Pregnant or breastfeeding
- •13. Inability to withhold antihistamines for 5 half-lives prior to the initial day of escalation or visits at which an SPT or OLFC is conducted
- •14. Discontinued early from the parent study for any safety reason (other than a subject from study ARC004 who has experienced a lack of tolerance for a nondaily dosing regimen)
- •15. Any other condition that, in the opinion of the investigator, precludes participation for reasons of safety
- •16. Subjects unable to follow the protocol requirements
研究者
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