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Phase 3, Open-label Apremilast Pediatric Long-term Extension Study in Children with Oral Ulcers Associated With Behçet’s Disease or Juvenile Psoriatic Arthritis
EU CTIS ID: 2023-503433-21-00
What this study is testing
Evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active JPsA that have completed Study 20190530 or Study 20190529
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Subject must be < 18 years of age at the time the informed consent document is signed and have completed week 52 (Apremilast Active TreatmenPhase) of Study 20190529 (from a country without another mechanism for post-trial access to apremilast for JPsA) or Study 20190530, where drug is not approved for the subject’s pediatric therapeutic indication in their country.
- 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 enrollment.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject must have acceptable benefit/risk for continued treatment with apremilast.
You likely can't join if
- 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.
- Scheduled surgery or other interventions that would interrupt the subject’s participation in the study.
- Female subjects of childbearing potential (for the purpose of this study, a female subject is considered of childbearing potential if she is ³ 12 years old 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.
- Female subjects planning to become pregnant while on study through 30 days after the last dose of investigational product.
- Female subjects of childbearing potential with a positive pregnancy test assessed at week 0 by a highly sensitive urine or serum pregnancy test.
- Subject has known sensitivity to any of the products to be administered during dosing.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Israel
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Israel; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.