New drug aims to silence painful mouth ulcers

NCT ID NCT04227314

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Ap-Hm La Timone

    RECRUITING

    Marseille, 13385, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Ap-Hp Avicenne

    RECRUITING

    Bobigny, 93000, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Ap-Hp Pitie Salpetriere

    RECRUITING

    Paris, 75013, France

    Contact Email: •••••@•••••

    Contact

  • Ap-Hp Pitie-Salpetriere

    NOT_YET_RECRUITING

    Paris, 75013, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • CHU NICE

    RECRUITING

    Nice, 06000, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Ch Creteil

    RECRUITING

    Créteil, 94010, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Ch Le Mans

    RECRUITING

    Le Mans, 72037, France

    Contact Email: •••••@•••••

    Contact

  • Ch Saint-Brieux

    NOT_YET_RECRUITING

    Saint-Brieuc, 22023, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chru Brest

    RECRUITING

    Brest, 29200, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chru Tours

    RECRUITING

    Tours, 37170, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Amiens

    NOT_YET_RECRUITING

    Amiens, 80054, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Bordeaux

    RECRUITING

    Bordeaux, 33076, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Lille

    RECRUITING

    Lille, 59000, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Montpellier

    RECRUITING

    Montpellier, 34295, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Nantes

    RECRUITING

    Nantes, 44000, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Reims

    RECRUITING

    Reims, 51092, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Rouen

    RECRUITING

    Rouen, 76031, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Saint-Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42055, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Chu Toulouse

    RECRUITING

    Toulouse, 31059, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hcl Hopital Edouard Herriot

    RECRUITING

    Lyon, 69003, France

    Contact Email: •••••@•••••

    Contact

  • Hopital Cochin

    RECRUITING

    Paris, 75014, France

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact