Status:
RECRUITING
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Lead Sponsor:
Amgen
Conditions:
Behçet's Disease
Juvenile Psoriatic Arthritis
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
Brief Summary
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 wi...
Eligibility Criteria
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
Key Trial Info
Start Date :
March 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2036
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05767047
Start Date
March 23 2023
End Date
March 17 2036
Last Update
December 1 2025
Active Locations (7)
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1
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, Greece, 54642
2
Meir Medical Center
Kfar Saba, Israel, 4428164
3
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026
4
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034