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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this study is to evaluate the long-term safety of apremilast in participants 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:
• 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)
• Willing to adhere to study visit schedule and protocol requirements
• Must have acceptable benefit/risk for continued treatment with apremilast
Locations
Other Locations
Greece
General Hospital of Thessaloniki Ippokrateio
RECRUITING
Thessaloniki
Israel
Meir Medical Center
RECRUITING
Kfar Saba
Spain
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
RECRUITING
Ankara
Istanbul Universitesi Cerrahpasa Tip Fakultesi
RECRUITING
Istanbul
Umraniye Egitim ve Arastirma Hastanesi
RECRUITING
Istanbul
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date:2023-03-23
Estimated Completion Date:2036-03-17
Participants
Target number of participants:48
Treatments
Experimental: Apremilast
Participants with a weight between ≥ 12 kg to \< 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to \< 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.