NCT04227314

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Aphtous Stomatitis

Interventions

Type	Name	Description
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,

Timeline

• Start date: 2022-04-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-01-13
• Last updated: 2026-02-17

Locations

21 sites across 1 country: France