Clinical Trial

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

Study acronym: PREMS
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-01-09; most recent amendment 2026-02-13.
Status change: Not Yet Recruiting → Recruiting 2026-02-13
Trial Details
NCT Number NCT04227314
Lead Sponsor University Hospital, Rouen
Conditions Recurrent Aphtous Stomatitis
Enrollment 134 participants
Start Date 2022-04-10
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-17