Using Apremilast to treat oral ulcers in children with Behçet's disease or juvenile psoriatic arthritis
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
This study is testing if the medication apremilast can safely help children with oral ulcers from Behçet's disease or juvenile psoriatic arthritis feel better over a longer time.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Amgen Industry-sponsored |
| Locations | 7 sites (Thessaloniki and 6 other locations) |
| Trial ID | NCT05767047 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety of apremilast in children aged 2 years and older with oral ulcers related to Behçet's disease or those aged 5 years and older with active juvenile psoriatic arthritis. Participants must have previously completed a core study and will be monitored for their response to the treatment over an extended period. The study aims to ensure that the benefits of continued treatment with apremilast outweigh any risks involved.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 years and older with oral ulcers due to Behçet's disease or those aged 5 years and older with juvenile psoriatic arthritis who have completed prior studies.
Not a fit: Patients who have not completed the core study or those with contraindications to apremilast may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of oral ulcers in affected children, enhancing their quality of life.
How similar studies have performed: Other studies have shown promise in using apremilast for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Thessaloniki and 6 other locations
- General Hospital of Thessaloniki Ippokrateio — Thessaloniki, Greece (Recruiting)
- Meir Medical Center — Kfar Saba, Israel (Recruiting)
- Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain (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)
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.