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A study to evaluate the long-term safety of apremilast in children with oral ulcers from Behçet’s disease or juvenile psoriatic arthritis

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the long-term safety of apremilast in children and young people. The research focuses on individuals living with Behçet’s disease, a long-term condition that causes inflammation throughout the body, or Juvenile Psoriatic Arthritis, a type of chronic joint inflammation that begins in childhood. In both conditions, the study specifically looks at those experiencing oral ulcers, which are painful sores located inside the mouth.

Participants in this study will take apremilast as an oral medication, which can be provided in the form of a film coated tablet or an oral solution. This is an open-label study, meaning that both the researchers and the participants will know which medication is being used. The study is a long-term extension, meaning it follows individuals who have previously participated in other research studies involving this same medication.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    Take apremilast as a 60 mg dose. the medication is provided as a film coated tablet or an oral solution to be taken by mouth.

    This study is a long-term extension, meaning the medication is used over an extended period of time to monitor safety.

  2. Step 2

    <b>safety monitoring and assessments</b>

    Attend regular evaluations to monitor safety. this includes tracking any adverse events, which are unexpected medical problems or side effects.

    Complete the columbia-suicide severity rating scale, which is a tool used to assess mood and mental well-being.

    Undergo tanner staging, which is a process used to measure physical development and puberty.

    Have body weight, height, and body mass index (bmi) measured. bmi is a calculation used to determine if body weight is healthy for a specific height.

    Provide samples for laboratory parameters, which are tests performed on blood or other fluids to check how the body is functioning.

    Have vital signs checked, such as blood pressure and heart rate.

Who can join the trial?

7 criteria

  • The person's legal guardian must give permission for them to join, and the person must also agree to participate if they are old enough to understand.
  • For those with Behçet’s disease (a condition causing inflammation and sores), they must be at least 2 years old and have oral ulcers (painful sores inside the mouth).
  • For those with juvenile idiopathic arthritis (a long-term condition causing joint swelling and pain in children), they must be at least 5 years old, have active JPsA (ongoing joint inflammation), and have already finished one of the previous specific studies.
  • The person must be under 18 years old at the time they sign the permission forms.
  • The person's Body Mass Index (a measure used to see if a person's weight is healthy for their height) must be at or above the 5th percentile on the official growth charts for their age and sex.
  • The person must be willing and able to follow the schedule of visits and all other rules of the study.
  • A doctor must determine that the potential benefits of taking the study medicine, apremilast, outweigh the potential risks for that specific person.

Who cannot join the trial?

6 criteria

  • If you answered "Yes" to any question regarding **suicidal thoughts or behaviors** on the specific mental health assessment scale used during your previous study visits.
  • If you have a surgery (a medical procedure involving cutting into the body) or other medical treatments planned that would stop you from being able to complete the study.
  • If you are a female who is able to become pregnant (defined as being 12 years or older or having started your menarche, which is your first menstrual period) and you are not willing to use the specific contraception (methods used to prevent pregnancy, such as birth control) required by the study rules during treatment and for 30 days after the last dose.
  • If you are a female planning to become pregnant (expecting a baby) during the study period or within 30 days after taking the last dose of the study medicine.
  • If you are a female who is able to become pregnant and have a positive pregnancy test (a test to check if you are pregnant) using a highly sensitive urine or serum (the liquid part of your blood) test at the start of the study.
  • If you have a known sensitivity (an allergic reaction or a negative response) to any of the medicines or products that will be given to you during the study.
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Investigated drugs

Apremilast is an oral medication being studied to see how safe it is when taken over a long period of time by children and young people who have mouth sores caused by Behçet’s disease or who have juvenile psoriatic arthritis.

What is already known about the treatment

Apremilast - This medication is taken by mouth in the form of tablets or a liquid solution to treat inflammatory conditions like Behçet’s disease and juvenile psoriatic arthritis. It is currently a recognized treatment used to manage symptoms caused by an overactive immune system. The drug works by blocking a specific enzyme inside immune cells, which helps to reduce the production of proteins that cause swelling and inflammation throughout the body. It is classified as a phosphodiesterase 4 inhibitor.

Investigated diseases

Behçet’s disease - This is a chronic inflammatory disorder that affects multiple parts of the body. It is characterized by recurring symptoms such as mouth sores, genital sores, skin lesions, and eye inflammation. In some cases, it can also involve the joints, the digestive tract, or the central nervous system. The condition tends to progress through periods of flare-ups and remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503433-21-00Protocol code20190531Estimated enrolment49 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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