ClinicalTrials.gov record NCT05767047

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age2 years old to 18 years old
SexAll
LocationGreece, Israel, Spain, Turkey
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label Phase 3 extension follows children who completed an earlier apremilast trial to evaluate long-term safety. Participants receive oral apremilast in weight-based doses and are followed for up to about 4 years with regular safety checks. The study monitors adverse events, growth and development, laboratory values, vital signs, and suicide-risk assessments.

What it is studying. The study is testing the long-term safety of apremilast in children with oral ulcers associated with Behçet's disease or juvenile psoriatic arthritis.

What the researchers hope to learn. To collect long-term safety and developmental data on apremilast in children with oral ulcers linked to Behçet's disease or juvenile psoriatic arthritis, including rates and types of adverse events, changes in growth and BMI, laboratory and vital-sign changes, and suicide-risk assessments.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Apremilast

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Enroll after finishing the core study and take apremilast orally (tablets or liquid) twice daily; dose is set by weight (about 10 mg, 20 mg, or 30 mg twice daily per the record). Attend regular clinic visits for safety monitoring over the long-term extension (up to about 4 years), which include reporting side effects, suicide-risk questionnaires (C-SSRS), growth and puberty checks (height, weight, BMI, Tanner staging), vital signs, and routine laboratory tests. Female participants of childbearing potential will have pregnancy testing and must follow the study contraception requirements. Scheduled surgeries or other procedures that would interrupt participation are not allowed while on study.

How the study is structured. Open-label, long-term extension in which eligible children receive apremilast by mouth in weight-based doses. There is no placebo or blinding. Safety data are collected over time (up to approximately 4 years) through adverse-event reporting, physical measurements (weight, height, BMI), Tanner staging, laboratory tests, vital signs, and repeated suicide-risk questionnaires.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Behçet's Disease; Juvenile Psoriatic Arthritis. Does it apply to my diagnosis?
  • The listed sites are in Greece, Israel, Spain, Turkey. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

This trial is also listed on this site under Behçet's disease.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 23, 2023
Primary completion
Mar 17, 2036 (estimated)
Study completion
Mar 17, 2036 (estimated)
Target enrollment
48 participants (estimated)
Last updated on registry
Dec 1, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Amgen

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (7)

  • General Hospital of Thessaloniki IppokrateioRecruiting

    Thessaloniki, 54642 · Greece

  • Meir Medical CenterRecruiting

    Kfar Saba, 4428164 · Israel

  • Hospital Universitari i Politecnic La FeRecruiting

    Valencia, Valencia, 46026 · Spain

  • Hospital Universitario Ramon y CajalRecruiting

    Madrid, 28034 · Spain

  • Hacettepe Universitesi Tip Fakultesi HastanesiRecruiting

    Ankara, 06100 · Turkey (Türkiye)

  • Istanbul Universitesi Cerrahpasa Tip FakultesiRecruiting

    Istanbul, 34098 · Turkey (Türkiye)

  • Umraniye Egitim ve Arastirma HastanesiRecruiting

    Istanbul, 34764 · Turkey (Türkiye)

Terms used on this page · explanations by MedicalUpdates.ai

primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
Informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
assent
A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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