RECRUITINGPhase 3INTERVENTIONAL
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
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
About This Trial
The primary objective of this study is to 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 juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.
Who May Be Eligible (Plain English)
Who May Qualify:
- willing to sign a consent form / assent obtained
- Must have completed Week 52 on treatment on core study and must be \< 18 years of age at the time the willing to sign a consent form document is signed
- Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment
- Willing to adhere to study visit schedule and protocol requirements
- Must have acceptable benefit/risk for continued treatment with apremilast
Who Should NOT Join This Trial:
- Answer "yes" to any question on C-SSRS at Week 52 visit of core study
- Scheduled surgery or other interventions that would interrupt study participation
- Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
- Female participants planning to become pregnant while on study through 30 days after last dose
- Female participants of childbearing potential with positive pregnancy test at Week 0
- Known sensitivity to any products to be administered during dosing
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Informed consent / assent obtained
* Must have completed Week 52 on treatment on core study and must be \< 18 years of age at the time the informed consent document is signed
* Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment
* Willing to adhere to study visit schedule and protocol requirements
* Must have acceptable benefit/risk for continued treatment with apremilast
Exclusion Criteria:
* Answer "yes" to any question on C-SSRS at Week 52 visit of core study
* Scheduled surgery or other interventions that would interrupt study participation
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
* Female participants planning to become pregnant while on study through 30 days after last dose
* Female participants of childbearing potential with positive pregnancy test at Week 0
* Known sensitivity to any products to be administered during dosing
Treatments Being Tested
DRUG
Apremilast
Oral tablets or liquid suspension
Locations (7)
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, Greece
Meir Medical Center
Kfar Saba, Israel
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey (Türkiye)
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, Turkey (Türkiye)