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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (3 UK sites)
Birmingham Childrens Hospital
Birmingham B4 6NH, United Kingdom
Alder Hey Childrens Hospital
Liverpool L12 2AP, United Kingdom
John Radcliffe Hospital
Oxford OX3 7LD, United Kingdom
How to Get in Touch
Amgen Call Center
Sponsor contactCONTACT
