A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-18
SponsorAmgen
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Apremilast
DrugOral tablets or liquid suspension
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: ApremilastExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Time frame
Up to approximately 4 years2
Columbia-Suicide Severity rating Scale (C-SSRS)
A questionnaire used to assess suicide risk.
Time frame
Up to approximately 4 years3
Tanner Staging
Tanner Staging of sexual development assessment will be used to assess sexual maturity.
Time frame
Up to approximately 4 years4
Change from Baseline in Body Weight
Time frame
Up to approximately 4 years Source ClinicalTrials.gov