A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis

Amgen Inc0 个研究点目标入组 48 人开始时间: 2023年1月20日最近更新: 2024年2月26日

适应症

试验速览

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•1. Subject’s legally authorized representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
•2. Subject must have completed week 52 (Apremilast Active Treatment Phase) of Study 20190529 (from France and Turkey sites only) or Study 20190530 where drug is not commercially available in their country.
•3. Subject must have an age and sex specific body mass index (BMI) value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart (Appendix 11.7) for children and adolescents (CDC, 2000) at randomization.
•4. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
•5. Subject must have acceptable benefit/risk for continued treatment with apremilast.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Answer Yes” to any question on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the week 52 visit on Study 20190529 (subjects from France and Turkey sites only) or Study 20190530.
•2. Scheduled surgery or other interventions that would interrupt the subject’s participation in the study.
•3. Female subjects of childbearing potential (for the purpose of this study, a female subject is considered of childbearing potential if she is 12 years old or older or has reached menarche, whichever occurred first) unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 30 days after the last dose of investigational product.
•4. Female subjects planning to become pregnant while on study through 30 days after the last dose of investigational product.
•5. Female subjects of childbearing potential with a positive pregnancy test assessed at week 0 by a highly sensitive urine or serum pregnancy test.
•6. Subject has known sensitivity to any of the products to be administered during dosing.
•7. Subject likely to not be available to complete all protocol-required study visits.

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