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Looking for participantsPhase3

Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease

Sponsor: Amgen

NCT ID: NCT04528082

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Apremilast (drug), Placebo (drug)
How long the study runs
Study runs about 111 months (dates as stated)
About the drug or intervention
Apremilast — drug: Participants will receive apremilast orally. · Placebo — drug: Participants will receive the matching placebo orally.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether a medicine called apremilast can help children with Behçet's disease who have active mouth ulcers. Behçet's disease is a condition that can cause painful ulcers in the mouth and other symptoms. The study is being run by a company called Amgen.

Who can take part

  • Children aged 2 to under 18, of either sex
  • Diagnosed with Behçet's disease using the ISGBD criteria (a set of standard rules doctors use) at some point before screening
  • Has had mouth ulcers 3 or more times in the 12 months before screening
  • Has at least 2 mouth ulcers at the screening visit and again on day 1
  • Has already tried at least 1 non-biologic treatment for Behçet's disease, such as corticosteroid creams or other medicines taken by mouth or applied to the skin

Who may not be able to

  • Active Behçet's disease affecting major organs, such as the lungs (for example, an aneurysm in a lung artery), blood vessels (for example, inflamed veins with clots), gut (for example, ulcers in the digestive tract), or brain and nervous system (for example, meningoencephalitis), or eye problems (for example, uveitis) that need immunosuppressive therapy (medicines that calm the immune system)
  • Past major organ involvement is allowed only if it happened at least 1 year before screening and is not active when joining
  • Mild eye problems that do not need systemic immunosuppressive therapy (medicine affecting the whole body) are allowed, as are joint pain or skin problems related to Behçet's disease
  • Has had biologic therapies (medicines made from living cells) for Behçet's disease mouth ulcers before. Biologic treatment for other conditions, including other Behçet's disease symptoms, is allowed

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
2 Years to 17 Years
Who
All
Number of participants
60
Started
2021-09-09
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for behçet disease
  • • Phase3 - 60 participants
  • • The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to \< 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12

Who can take part?

  • • Ages 2 Years to 17 Years
  • • Diagnosed with behçet disease

Where?

  • • Birmingham - Birmingham Childrens Hospital
  • • Liverpool - Alder Hey Childrens Hospital
  • • Oxford - John Radcliffe Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to \< 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.

Behçet Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 2 Years - 17 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ ≥ 2 oral ulcers at both the screening visit and on day 1
  • ✓ ≥ 1 non-biologic BD therapy

What the study is looking for

  • ✓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.
See the full criteria
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).

Where Is This Study? (3 UK sites)

Birmingham Childrens Hospital

Birmingham B4 6NH, United Kingdom

TERMINATED
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Alder Hey Childrens Hospital

Liverpool L12 2AP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Kelly Davies

research@alderhey.nhs.uk0151 2525570

John Radcliffe Hospital

Oxford OX3 7LD, United Kingdom

Recruiting

How to Get in Touch

Amgen Call Center

Sponsor contact

CONTACT

866-572-6436 medinfo@amgen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07