Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
University Hospital, Rouen
134 participants
Apr 10, 2022
INTERVENTIONAL
Conditions
Summary
The objective of the study is to assess the superiority of apremilast in comparison with placebo to achieve Complete Remission (CR) of oral ulcers at Week 12, in patients with severe Recurrent aphtous stomatitis resistant or intolerant to colchicine.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Apremilast: 30 mg twice daily during a 12 week double blind placebo controlled period, then 30 mg twice daily during an additional 12 week active treatment period
Placebo: 30 mg twice daily during the initial 12 week double blind placebo controlled period,
Locations(21)
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NCT04227314