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

Study acronym: PREMS
StatusRecruiting
PhasePhase 3
Started2022-04-10
View on ClinicalTrials.gov ↗

Amendment history

2026-02-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-06→2026-12
Completion date2027-06→2026-12
Start dateestimated 2022-01→confirmed 2022-04-10
Study sites0→21
2021-11-19
Study Status v2
Primary completion date2026-09→2027-06
Completion date2026-09→2027-06
Start date2021-09→2022-01
2021-04-08
Study Identification, Study Status v1
Primary completion date2025-01→2026-09
Completion date2025-01→2026-09
Start date2020-09→2021-09
2020-01-09
Original filing
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.
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