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New hope for kids with painful mouth sores: drug trial launches

NCT ID NCT04528082

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests whether the drug apremilast (Otezla) can reduce painful mouth ulcers in children aged 2 to 17 with Behçet's disease. About 60 participants will receive either apremilast or a placebo for 12 weeks to see if the drug works better than a dummy pill. The goal is to help kids have fewer and less painful ulcers, improving their quality of life.

What this could mean

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

Active substance
apremilast (Otezla)
What this could lead to
If it works, this could give children with Behçet's disease a new treatment option to reduce painful mouth ulcers and improve daily life.
What could go wrong
This is still a clinical trial with only 60 participants, so results may not apply to everyone. Apremilast can cause side effects like nausea or diarrhea, and it may not work better than placebo.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria * Male or Female participants 2 to \< 18 years of age at randomization. * Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit. * Oral ulcers that occurred ≥ 3 times within the 12-month period prior to the screening visit. * Participant must have ≥ 2 oral ulcers at both the screening visit and on day 1. * Participant has had prior treatment with ≥ 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment. Key Exclusion Criteria * Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), or CNS (eg, meningoencephalitis) manifestations, or ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however: * Previous major organ involvement is allowed if it occurred ≥1 year prior to the screening visit and is not active at time of enrollment * Participants with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed * Participants with BD-related arthritis and BD-skin manifestations are also allowed. * Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).

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Conditions

The condition(s) this trial relates to.

Behcet disease Oral Ulcer

As listed by the trial registrant

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

Behçet disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Agia Sofia Children Hospital

    RECRUITING

    Athens, 11527, Greece

  • Alder Hey Childrens Hospital

    RECRUITING

    Liverpool, L12 2AP, United Kingdom

  • Attikon University General Hospital

    RECRUITING

    Athens, 12462, Greece

  • Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

    TERMINATED

    Milan, 20122, Italy

  • Birmingham Childrens Hospital

    TERMINATED

    Birmingham, B4 6NH, United Kingdom

  • Centre Hospitalier Universitaire Vaudois

    TERMINATED

    Lausanne, 1011, Switzerland

  • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

    TERMINATED

    Izmir, 35330, Turkey (Türkiye)

  • Erciyes Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Kayseri, 38030, Turkey (Türkiye)

  • General Hospital of Thessaloniki Ippokrateio

    RECRUITING

    Thessaloniki, 54642, Greece

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Hopital Necker Enfants Malades

    TERMINATED

    Paris, 75015, France

  • Hopital Robert Debre

    RECRUITING

    Paris, 75019, France

  • Hospices Civils de Lyon Hopital Femme Mere Enfant

    RECRUITING

    Bron, 69677, France

  • Hospital Sant Joan de Deu

    RECRUITING

    Esplugues de Llobregat, Catalonia, 08950, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario La Paz

    TERMINATED

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genova, 16147, Italy

  • IRCCS Ospedale Pediatrico Bambino Gesu

    RECRUITING

    Roma, 00165, Italy

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 7LD, United Kingdom

  • Meir Medical Center

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Ospedale Santissima Annunziata

    TERMINATED

    Chieti, 66100, Italy

  • Umraniye Egitim ve Arastirma Hastanesi

    RECRUITING

    Istanbul, 34764, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.