RecruitingPhase 3NCT04227314

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


Sponsor

University Hospital, Rouen

Enrollment

134 participants

Start Date

Apr 10, 2022

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Apremilast and a drug called Placebo oral tablet for people with recurrent aphtous stomatitis. The study is currently recruiting participants at 21 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApremilast

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

DRUGPlacebo oral tablet

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


Locations(21)

Chu Amiens

Amiens, France

Ap-Hp Avicenne

Bobigny, France

Chu Bordeaux

Bordeaux, France

Chru Brest

Brest, France

Ch Creteil

Créteil, France

Ch Le Mans

Le Mans, France

Chu Lille

Lille, France

Hcl Hopital Edouard Herriot

Lyon, France

Ap-Hm La Timone

Marseille, France

Chu Montpellier

Montpellier, France

Chu Nantes

Nantes, France

CHU NICE

Nice, France

Ap-Hp Pitie Salpetriere

Paris, France

Ap-Hp Pitie-Salpetriere

Paris, France

Hopital Cochin

Paris, France

Chu Reims

Reims, France

Chu Rouen

Rouen, France

Ch Saint-Brieux

Saint-Brieuc, France

Chu Saint-Etienne

Saint-Etienne, France

Chu Toulouse

Toulouse, France

Chru Tours

Tours, France

View Full Details on ClinicalTrials.gov

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NCT04227314