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Study on Apremilast for Patients with Severe Recurrent Mouth Ulcers Resistant to Colchicine

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a condition known as Recurrent Aphthous Stomatitis (RAS), which is characterized by painful mouth ulcers that frequently recur. The study is investigating the effectiveness and safety of a medication called Apremilast, which is taken as a film-coated tablet. Apremilast is being compared to a placebo to determine if it can help achieve complete remission of these oral ulcers in patients who have severe RAS and have not responded well to another medication called colchicine.

The purpose of the study is to see if Apremilast can help patients with severe RAS by reducing or eliminating their mouth ulcers over a period of time. Participants in the study will be randomly assigned to receive either Apremilast or a placebo. The study will last for several weeks, during which time the participants will take the medication and have regular check-ups to monitor their progress. The main goal is to see if the ulcers are completely gone at specific points during the study.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to assess the effectiveness of the treatment. The study aims to provide valuable information on whether Apremilast can be a beneficial treatment option for those suffering from severe forms of RAS, offering hope for better management of this painful condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have read and understood the information letter and signed the informed consent form.
Eligibility includes being 18 years or older with severe recurrent aphthous stomatitis (RAS) that is resistant or intolerant to colchicine.
Step 2
Randomization
The patient will be randomly assigned to receive either apremilast or a placebo. This process is double-blind, meaning neither the patient nor the evaluator will know which treatment is being administered.
Step 3
Treatment administration
The treatment involves taking the assigned medication orally. The specific dosage and frequency will be provided by the study team.
The primary goal is to achieve sustained complete remission of oral ulcers by Week 12, Week 14, and Week 16.
Step 4
Evaluation
The patient's progress will be evaluated at Weeks 12, 14, and 16 to determine if there is a complete response, meaning no oral ulcers are present.
Evaluations are conducted by a blind evaluator to ensure unbiased results.
Step 5
Completion
The study is estimated to conclude by April 10, 2026. The patient will be informed of the study's outcome and any relevant findings.

Who can join the trial?

11 criteria

Patients must be male or female and at least 18 years old.
Patients should have severe forms of Recurrent Aphthous Stomatitis (RAS), which are painful mouth ulcers.
Patients must have tried colchicine, a medication, at a dose of 1mg/day or more for at least 3 months without success, or they cannot tolerate it.
Patients should have at least one large mouth ulcer (1cm or more) confirmed by a doctor in the last 3 months, or multiple mouth ulcers (4 or more) at the same time, or continuous development of new mouth ulcers over the last 3 months.
Patients should have mouth ulcers that occur for at least 7 days each month over the last 3 months.
Patients should experience major pain from mouth ulcers that affects eating, speaking, or swallowing.
Patients must have read and understood the information about the study and signed a consent form agreeing to participate.
Women who can have children must use effective birth control methods and have a negative pregnancy test.
Women who are surgically sterile or postmenopausal (no periods for at least 12 months) can participate.
Patients must be able to follow the study rules and procedures, as judged by the doctor.
Patients must have health insurance or be part of a social security system.

Who cannot join the trial?

4 criteria

Patients who do not have severe forms of Recurrent Aphthous Stomatitis (RAS). RAS is a condition where painful sores or ulcers appear in the mouth repeatedly.
Patients who are not resistant or intolerant to colchicine. Colchicine is a medication often used to treat gout and other conditions, and being resistant or intolerant means it does not work for them or causes bad side effects.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Centre Hospitalier Intercommunal Creteil
Creteil, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France

Trial locations

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Investigated drugs

Apremilast is a medication being tested in this trial to see if it can help people with severe recurrent aphthous stomatitis, which is a condition that causes painful mouth ulcers. The study aims to find out if apremilast can lead to complete healing of these ulcers in patients who have not responded well to other treatments like colchicine.

Apremilast

What is already known about the treatment

Apremilast – Apremilast is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating severe forms of Recurrent Aphthous Stomatitis (RAS), particularly in patients who do not respond well to colchicine. The medication works by inhibiting an enzyme called phosphodiesterase 4 (PDE4), which leads to a reduction in inflammation. Apremilast is classified as a phosphodiesterase inhibitor and is being evaluated for its ability to achieve complete remission of oral ulcers in affected patients.

Investigated diseases

Recurrent Aphthous Stomatitis – Recurrent Aphthous Stomatitis (RAS) is a condition characterized by the repeated formation of painful ulcers in the mouth. These ulcers, often referred to as canker sores, typically appear on the inner lining of the cheeks, lips, or tongue. The exact cause of RAS is not well understood, but it is believed to involve a combination of genetic, immune, and environmental factors. The ulcers usually begin as small, round, or oval sores with a red border and a yellow or white center. They can cause discomfort, especially when eating or speaking, and tend to heal on their own within one to two weeks. In severe cases, the ulcers may be larger, more numerous, and take longer to heal, significantly affecting the quality of life.