Study on Apremilast for Treating Oral Ulcers in Children with Behçet’s Disease

3 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called Apremilast in children who have active oral ulcers associated with Behçet’s Disease. Behçet’s Disease is a rare condition that causes inflammation of the blood vessels, leading to symptoms like mouth sores, eye inflammation, skin rashes, and genital sores. The purpose of this study is to evaluate how effective and safe Apremilast is for treating these oral ulcers in children aged 2 to less than 18 years.

Participants in the study will be randomly assigned to receive either Apremilast or a placebo. Apremilast is taken orally, either as a film-coated tablet or an oral solution. The study will begin with a phase where neither the participants nor the researchers know who is receiving the actual medication or the placebo. This is followed by a phase where all participants will receive Apremilast. The study will last for up to 52 weeks, with regular check-ups to monitor the number of oral ulcers, any changes in pain levels, and overall health and safety.

The study aims to see if Apremilast can reduce the number of oral ulcers and improve the quality of life for children with Behçet’s Disease. Researchers will also look at other factors, such as any side effects, changes in disease activity, and overall growth and development of the participants. This information will help determine if Apremilast is a suitable treatment option for managing oral ulcers in children with Behçet’s Disease.

1 randomization and initial assessment

Upon joining the study, participants are randomly assigned to receive either the study medication or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.

An initial assessment is conducted to record the number of oral ulcers and other relevant health information.

2 medication administration

Participants receive apremilast or a placebo in the form of film-coated tablets or oral solution. The dosage is adjusted according to the participant’s age and weight.

The medication is taken orally as prescribed, with the frequency and duration determined by the study protocol.

3 treatment phase

The treatment phase lasts for 12 weeks. During this time, participants continue to take the assigned medication and attend regular study visits.

The primary goal is to evaluate the reduction in the number of oral ulcers and any changes in pain levels.

4 evaluation and monitoring

Throughout the study, participants undergo regular evaluations to monitor the number of oral ulcers, pain levels, and any side effects.

Additional assessments include changes in disease activity, overall health, and any new symptoms related to Behçet’s Disease.

5 end of treatment phase

At the end of the 12-week treatment phase, a comprehensive evaluation is conducted to assess the effectiveness of the treatment.

Participants who show significant improvement may continue to receive the active treatment in an open-label extension phase.

6 safety follow-up

A 30-day post-treatment safety follow-up is conducted to monitor any delayed side effects or health changes.

Participants’ health and any adverse events are closely monitored during this period.

Who Can Join the Study?

The patient must be a boy or girl between 2 and less than 18 years old.
The patient must have been diagnosed with Behcet’s Disease (BD) at any time before the first visit for the study. Behcet’s Disease is a condition that causes inflammation in blood vessels.
The patient must have had oral ulcers (painful sores in the mouth) at least 3 times in the 12 months before the first visit for the study.
The patient must have at least 2 oral ulcers at both the first visit for the study and on the first day of the study.
The patient must have tried at least one previous treatment for Behcet’s Disease that is not a biologic therapy. This could include treatments like topical corticosteroids (medications applied to the skin to reduce inflammation) or other systemic treatments (medications that work throughout the body).
The patient must be suitable for systemic therapy to treat oral ulcers. Systemic therapy means treatment that affects the whole body, not just one part.

Who Cannot Join the Study?

Patients who are not between the ages of 2 and less than 18 years old.
Patients who do not have oral ulcers (painful sores in the mouth) associated with Behçet’s Disease.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are taking other medications that might interfere with the study treatment.
Patients who have had a recent infection or illness that could affect their participation in the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication or similar medications.
Patients who have participated in another clinical trial recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hopital Necker Enfants Malades	Paris	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Robert Debre University Hospital	Paris	France
Hospital Femme Mere Enfant	Bron	France
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti	Chieti	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
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
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Pdqk Trxhv Htgdxpum Uddoptzgxfyx	Sabadell	Spain
Fzqjdoehp Pssg Lo Iusuoobajmyso Bmuosvvqn Dfr Haltkclm Uuqqkatgmhplw Lj Pje	Madrid	Spain
Hcbznahh Vukh dqmjyxkw	Barcelona	Spain
Ulqjufauww Glarfmw Hnpnpyku Atvscih	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Not recruiting	09.09.2021
Greece	Not recruiting	09.09.2021
Italy	Not recruiting	09.09.2021
Spain	Recruiting	09.09.2021

Trial locations

Investigated drugs:

Apremilast

Apremilast is a medication being studied for its effectiveness in treating children with oral ulcers caused by Behçet’s Disease. It works by reducing inflammation in the body, which may help decrease the number and severity of the ulcers. This study aims to determine how well this medication can help manage symptoms in young patients.

Behcet’s Disease – Behcet’s Disease is a chronic condition that causes inflammation in blood vessels throughout the body. It often leads to symptoms such as mouth sores, eye inflammation, skin rashes, and genital sores. The disease can vary greatly in severity and symptoms from person to person. It typically progresses with periods of flare-ups and remissions. The exact cause of Behcet’s Disease is unknown, but it is believed to involve an abnormal immune response. Over time, the inflammation can lead to complications affecting various organs and systems in the body.

Oral Ulcers Associated with Behcet’s Disease – Oral ulcers are a common and painful symptom of Behcet’s Disease, characterized by recurrent sores in the mouth. These ulcers can vary in size and number, often appearing on the inner lips, cheeks, and tongue. They tend to heal within a few weeks but can recur frequently, causing significant discomfort. The progression of these ulcers is unpredictable, with periods of healing followed by new outbreaks. The exact mechanism causing these ulcers in Behcet’s Disease is not fully understood, but it is linked to the underlying inflammation of the disease. Managing these ulcers is crucial to improving the quality of life for those affected.

Trial ID:

2023-503436-40-00

Protocol code:

20190530

NCT ID:

NCT04528082

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Apremilast for Treating Oral Ulcers in Children with Behçet’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?