Ongoing Clinical Trials for Aphthous Ulcer
There is currently 1 ongoing clinical trial investigating treatments for aphthous ulcers (also known as recurrent aphthous stomatitis, canker sores, mouth ulcers). This trial is evaluating the effectiveness of apremilast in patients with severe recurrent mouth ulcers who have not responded well to standard treatment with colchicine.
Clinical trial locations
Study on Apremilast for Patients with Severe Recurrent Mouth Ulcers Resistant to Colchicine
This clinical trial is investigating whether apremilast, an oral medication, can help patients suffering from severe recurrent aphthous stomatitis. The condition causes painful mouth ulcers that frequently recur and can significantly impact daily activities like eating, speaking, and swallowing.
Main focus of the trial: The study aims to determine if apremilast can achieve complete remission of oral ulcers, meaning the ulcers disappear entirely. Researchers will compare apremilast to a placebo (an inactive treatment) to assess its effectiveness. The main evaluation points are at weeks 12, 14, and 16 of the treatment period. Apremilast works by inhibiting an enzyme called phosphodiesterase 4, which helps reduce inflammation in the body.
Who can participate: The trial is open to adults aged 18 years and older who have severe forms of recurrent mouth ulcers. To qualify, participants must have tried colchicine (a standard treatment) at a dose of at least 1 mg per day for at least 3 months without success, or they must be unable to tolerate this medication. Eligible patients should have experienced significant mouth ulcers in the past 3 months, either one large ulcer measuring 1 cm or more, or multiple ulcers (4 or more) appearing at the same time, or continuous development of new ulcers. The ulcers must occur for at least 7 days each month and cause major pain that affects eating, speaking, or swallowing. Women of childbearing age must use effective birth control and have a negative pregnancy test. Participants must also have health insurance or be part of a social security system and be able to follow the study procedures.
Who cannot participate: The trial excludes patients who do not have severe forms of recurrent aphthous stomatitis or those whose condition responds well to colchicine. Patients outside the specified age range or those belonging to vulnerable populations requiring special protection are also excluded.
Study design: This is a double-blind, randomized trial, meaning neither the participants nor the evaluators will know who is receiving apremilast and who is receiving the placebo. This design helps ensure unbiased results. Participants will take their assigned medication orally according to the dosage and frequency provided by the study team. Regular check-ups will monitor progress and ensure safety throughout the study period, which is expected to conclude by April 2026.
Summary
Currently, there is one clinical trial available for patients with severe aphthous ulcers who have not found relief with standard colchicine therapy. This trial is being conducted in France and focuses on evaluating apremilast, a phosphodiesterase inhibitor that reduces inflammation. The study represents an important opportunity for patients suffering from painful, recurrent mouth ulcers that significantly affect their quality of life. The research aims to provide evidence on whether apremilast can offer a new treatment option for managing this challenging condition.