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 range5 Years – 18 Years

SexALL

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

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

Number of Participants with Clinically Significant Changes in Laboratory Parameters

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 range5 Years – 18 Years

SexALL

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

Number of Participants with Clinically Significant Changes in Laboratory Parameters

Timeframe: Up to approximately 4 years