RecruitingPhase 3

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Greece, Israel, Spain48 participantsStarted 2023-03-23

Plain-language summary

The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.

Who can participate

Age range

5 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 3 trial testing apremilast specifically in children, what do we already know about how safe this drug is in adults or older patients, and does that change how you'd weigh the risks for my child?
2The trial is actively monitoring for suicidal thoughts using a formal rating scale called the C-SSRS — how serious is that risk with apremilast, and what warning signs should I watch for at home if my child were to participate?
3The study is tracking changes in my child's height, weight, and BMI over time — does that mean there's a concern this drug could affect their growth, and how would we monitor that?
4Given that this trial focuses on oral ulcers linked to Behçet's Disease or Juvenile Psoriatic Arthritis, does my child's specific diagnosis and symptom pattern make them a reasonable candidate to even discuss with the study team?
5Before considering this trial, are there standard approved treatments we should try first, or is apremilast something you'd consider if those haven't worked??

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adverse Events

Timeframe: Up to approximately 4 years

Columbia-Suicide Severity rating Scale (C-SSRS)

Timeframe: Up to approximately 4 years

Tanner Staging

Timeframe: Up to approximately 4 years

Change from Baseline in Body Weight

Timeframe: Up to approximately 4 years

Change from Baseline in Height

Timeframe: Up to approximately 4 years

Change from Baseline in Body Mass Index (BMI)

Timeframe: Up to approximately 4 years

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: Up to approximately 4 years

Trial details

NCT IDNCT05767047

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2036-03-17

Contact for this trial

Amgen Call Center

866-572-6436 medinfo@amgen.com

View on ClinicalTrials.gov More Behçet's Disease trials

Who can participate

Age range

5 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Adverse Events

Timeframe: Up to approximately 4 years

Columbia-Suicide Severity rating Scale (C-SSRS)

Timeframe: Up to approximately 4 years

Tanner Staging

Timeframe: Up to approximately 4 years

Change from Baseline in Body Weight

Timeframe: Up to approximately 4 years

Change from Baseline in Height

Timeframe: Up to approximately 4 years

Change from Baseline in Body Mass Index (BMI)

Timeframe: Up to approximately 4 years

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: Up to approximately 4 years