EUCTR2017-001334-26-GB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
- 950
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
- •A subject must meet all the following criteria to be eligible:
- •1. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC005, ARC007, ARC010, ARC011, or any future clinical study of 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 930
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject who meets any of the following criteria is 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 ARC010, or unless specified otherwise in the parent study
- •2. 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
- •3. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
- •4. 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
- •5. Taking a prohibited medication, as listed in Section 5.9.5
- •6. Currently participating in any other interventional clinical study other than the Aimmune parent study
- •7. 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
- •8. Subject is living in the same household or is a dependent of sponsor employee and/or site staff involved in conducting this study, except for subjects originating from Aimmune Studies ARC002, ARC004, ARC007, ARC010, and ARC011
- •9. Currently in the build-up phase of immunotherapy for any non-food allergen
- •10. Hypersensitivity to epinephrine or hypersensitivity to any of the excipients in the investigational product (IP)
- •11. Pregnant or breastfeeding
- •12. 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
- •13. Discontinued early from the parent study for any safety reason, except a subject from study ARC004 who has experienced a lack of tolerance for a nondaily dosing regimen, and subjects who discontinued early from an eligible parent study due to AEs (including chronic or recurrent GI AEs) who require continued safety follow-up only
- •14. Currently committed to an institution (eg, psychiatric institution, prison) by virtue of an order issued by judicial or administrative authorities
- •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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