A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Recruiting now · Phase 3
Conditions studied: Behçet's Disease, Juvenile Psoriatic Arthritis
In brief
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.
Key facts
- Study ID
- NCT05767047
- Run by
- Amgen
- People needed
- 48
- Starts
- 2023-03-23
- Expected to finish
- 2036-03-17
- Last updated by the study team
- 2025-12-01
Who can join
Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- General Hospital of Thessaloniki Ippokrateio — Thessaloniki, Greece (enrolling)
- Meir Medical Center — Kfar Saba, Israel (enrolling)
- Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain (enrolling)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
- Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
- Istanbul Universitesi Cerrahpasa Tip Fakultesi — Istanbul, Turkey (Türkiye) (enrolling)
- Umraniye Egitim ve Arastirma Hastanesi — Istanbul, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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