New drug aims to silence painful mouth ulcers

NCT ID NCT04227314

Recruiting now Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether the drug apremilast can completely clear painful mouth ulcers in people with severe recurrent aphthous stomatitis (RAS) that hasn't responded to colchicine. About 134 adults will receive either apremilast or a placebo twice daily for 12 weeks, followed by an active treatment period. The main goal is to see if more patients achieve total ulcer remission at 12 weeks with apremilast.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Apremilast (a drug taken as a pill twice daily)
What this could lead to: If it works, this could offer a new treatment option for people with severe, painful mouth ulcers that don't respond to standard therapy.
What could go wrong: This is a Phase 3 trial, but it's still relatively small (134 participants). The drug may not prove more effective than placebo, and side effects like nausea or diarrhea are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

aphthous stomatitis canker sore

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RECURRENT APHTOUS STOMATITIS

Contacts and locations

Locations

Ap-Hm La Timone
RECRUITING

Marseille, 13385, France
Ap-Hp Avicenne
RECRUITING

Bobigny, 93000, France
Ap-Hp Pitie Salpetriere
RECRUITING

Paris, 75013, France
Ap-Hp Pitie-Salpetriere
NOT_YET_RECRUITING

Paris, 75013, France
CHU NICE
RECRUITING

Nice, 06000, France
Ch Creteil
RECRUITING

Créteil, 94010, France
Ch Le Mans
RECRUITING

Le Mans, 72037, France
Ch Saint-Brieux
NOT_YET_RECRUITING

Saint-Brieuc, 22023, France
Chru Brest
RECRUITING

Brest, 29200, France
Chru Tours
RECRUITING

Tours, 37170, France
Chu Amiens
NOT_YET_RECRUITING

Amiens, 80054, France
Chu Bordeaux
RECRUITING

Bordeaux, 33076, France
Chu Lille
RECRUITING

Lille, 59000, France
Chu Montpellier
RECRUITING

Montpellier, 34295, France
Chu Nantes
RECRUITING

Nantes, 44000, France
Chu Reims
RECRUITING

Reims, 51092, France
Chu Rouen
RECRUITING

Rouen, 76031, France
Chu Saint-Etienne
NOT_YET_RECRUITING

Saint-Etienne, 42055, France
Chu Toulouse
RECRUITING

Toulouse, 31059, France
Hcl Hopital Edouard Herriot
RECRUITING

Lyon, 69003, France
Hopital Cochin
RECRUITING

Paris, 75014, France