NCT05767047RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated 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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 8 Mar 2023
- Start date
- 23 Mar 2023
- Primary completion date
- 17 Mar 2036
- Lead sponsor
- Amgen
- Diseases
- Psoriatic arthritis
- NCT number
- NCT05767047
- EudraCT number
- 2022-003024-41
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 48
- From 23 Mar 2023 to the primary completion date, 17 Mar 2036
- 7 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled surgery or other interventions that would interrupt study participation
Other
- Answer "yes" to any question on C-SSRS at Week 52 visit of core study
- 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
Who the study is looking for
- 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
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| General Hospital of Thessaloniki "IPPOKRATEIO" Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| Hacettepe Universitesi Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Umraniye Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.