NCT04227314View on ClinicalTrials.gov

Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

PHASE3Not yet recruitingINTERVENTIONAL

Enrollment

134

Participants

Timeline

Start Date

January 31, 2022

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions

Recurrent Aphtous Stomatitis

Interventions

DRUG

Apremilast

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

DRUG

Placebo oral tablet

Placebo: 30 mg twice daily during the initial 12 week double blind placebo controlled period,

All Listed Sponsors

lead

University Hospital, Rouen

OTHER