Clinical Trials in Spain / NCT05767047
Recruiting
Phase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
NCT05767047 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Behçet's DiseaseJuvenile Psoriatic Arthritis
Investigational drug(s) / intervention(s)
Apremilast: Oral tablets or liquid suspension
Study 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 with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.
Eligibility
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
Primary outcome measure(s)
- Number of Participants with Adverse Events — Up to approximately 4 years
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. - Columbia-Suicide Severity rating Scale (C-SSRS) — Up to approximately 4 years
A questionnaire used to assess suicide risk. - Tanner Staging — Up to approximately 4 years
Tanner Staging of sexual development assessment will be used to assess sexual maturity. - Change from Baseline in Body Weight — Up to approximately 4 years
- Change from Baseline in Height — Up to approximately 4 years
- Change from Baseline in Body Mass Index (BMI) — Up to approximately 4 years
- Number of Participants with Clinically Significant Changes in Vital Signs — Up to approximately 4 years
- Number of Participants with Clinically Significant Changes in Laboratory Parameters — Up to approximately 4 years
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| General Hospital of Thessaloniki Ippokrateio | Thessaloniki | Greece | Recruiting |
| Meir Medical Center | Kfar Saba | Israel | Recruiting |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Recruiting |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | Turkey (Türkiye) | Recruiting |
| Umraniye Egitim ve Arastirma Hastanesi | Istanbul | Turkey (Türkiye) | Recruiting |
On this site
📄 Otezla (apremilast) drug profile →More Amgen trials in Spain
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05767047 on ClinicalTrials.gov ↗ ← All trials in Spain