Using Apremilast to treat oral ulcers in children with Behçet's disease or juvenile psoriatic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing physical and psychosocial health in people with Takayasu arteritis, Behçet's disease, and healthy adults

  This will test whether adults with Takayasu arteritis or Behçet's disease have weaker respiratory and limb muscles, lower exercise capacity, or different quality of life and psychological well‑being compared with healthy adults.

  Recruiting Alanya Alaaddin Keykubat University · Denizli, Denizli · NCT07276087

• Evaluating Deucravacitinib for Juvenile Psoriatic Arthritis in Children

  This study is testing if a new medication called Deucravacitinib can help children with juvenile psoriatic arthritis who haven't had success with other treatments.

  Recruiting at 29 sites Phase 3 Bristol-Myers Squibb · Lancaster, California and 47 other locations · NCT06869551

• Evaluating the safety and effectiveness of intravenous secukinumab in children with juvenile psoriatic arthritis.

  This study is testing if an intravenous medication called secukinumab is safe and effective for children with juvenile psoriatic arthritis.

  Recruiting at 11 sites Phase 1 Novartis · Loma Linda, California and 10 other locations · NCT06751238

• Evaluating Bimekizumab for Pediatric Arthritis

  This study is testing a new medication called bimekizumab in children with certain types of arthritis to see if it is safe and effective for them.

  Recruiting at 21 sites Phase 3 UCB Pharma · Calgary and 22 other locations · NCT06668181

• Efficacy and safety of Hemay005 tablets for Behçet's disease

  This study is testing if Hemay005 tablets can help people with Behçet's disease feel better and be safe to use.

  Recruiting at 19 sites Phase 3 Ganzhou Hemay Pharmaceutical Co., Ltd · Beijing, Beijing Municipality and 21 other locations · NCT06145893

• Assessing the safety and effectiveness of risankizumab and adalimumab in children with juvenile psoriatic arthritis

  This study is testing a new medication called risankizumab to see if it works better and is safer than the standard treatment adalimumab for children with juvenile psoriatic arthritis.

  Recruiting at 34 sites Phase 3 AbbVie · Little Rock, Arkansas and 33 other locations · NCT06100744

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.