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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
IRCCS Istituto Giannina Gaslini Genoa Italy
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Nosokomeio Paidon I Agia Sofia Athens Greece
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Hospital Universitario Ramon Y Cajal Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Hefwkvcp Vild drsynlcf Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Recruiting
23.03.2023
Italy Italy
Recruiting
23.03.2023
Spain Spain
Recruiting
23.03.2023

Trial locations

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.

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 ID:
2023-503433-21-00
Protocol code:
20190531
NCT ID:
NCT05767047
Trial Phase:
Therapeutic confirmatory (Phase III)

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