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New study checks safety of apremilast for kids with painful mouth sores and arthritis

NCT ID NCT05767047

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at the long-term safety of the drug apremilast in children aged 2 and older with Behçet's disease (causing mouth ulcers) or aged 5 and older with juvenile psoriatic arthritis. About 48 kids who finished a previous study will take apremilast for up to 52 more weeks. Researchers will track side effects, growth, and development to make sure the drug is safe over time.

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 48 people

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

Started

Mar 2023

Expected to finish

Mar 2036

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

5 to 18 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.

Inclusion Criteria: * Informed consent / assent obtained * Must have completed Week 52 on treatment on core study and must be \< 18 years of age at the time the informed consent document is signed * Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment * Willing to adhere to study visit schedule and protocol requirements * Must have acceptable benefit/risk for continued treatment with apremilast Exclusion Criteria: * Answer "yes" to any question on C-SSRS at Week 52 visit of core study * Scheduled surgery or other interventions that would interrupt study participation * Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose * Female participants planning to become pregnant while on study through 30 days after last dose * Female participants of childbearing potential with positive pregnancy test at Week 0 * Known sensitivity to any products to be administered during dosing

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Conditions

The condition(s) this trial relates to.

Behcet disease juvenile idiopathic arthritis Oral Ulcer psoriasis-related juvenile idiopathic arthritis

As listed by the trial registrant

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

Behçet's disease Juvenile psoriatic arthritis

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

    7 sites in 4 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

  • General Hospital of Thessaloniki Ippokrateio

    RECRUITING

    Thessaloniki, 54642, Greece

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Meir Medical Center

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Umraniye Egitim ve Arastirma Hastanesi

    RECRUITING

    Istanbul, 34764, Turkey (Türkiye)

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