Clinical trial NCT05767047: A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Official title: A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Behçet's Disease
Juvenile Psoriatic Arthritis
Keywords: Oral Ulcers
Behçet's Disease
Juvenile Psoriatic Arthritis
Apremilast
AMG 407
Otezla
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the long-term safety of apremilast in participants 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.


Eligibility criteria: Inclusion Criteria:

* Informed consent / assent obtained
* Must have completed Week 52 on treatment on core study
* Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart)
* 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
* Not likely to be available to complete all protocol-required study visits

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to approximately 4 years
measure: Columbia-Suicide Severity rating Scale (C-SSRS)
timeFrame: Up to approximately 4 years
measure: Tanner Staging
timeFrame: Up to approximately 4 years
measure: Change from Baseline in Body Weight
timeFrame: Up to approximately 4 years
measure: Change from Baseline in Height
timeFrame: Up to approximately 4 years
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Up to approximately 4 years
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to approximately 4 years
measure: Number of Participants with Clinically Significant Changes in Laboratory Parameters
timeFrame: Up to approximately 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Ippokrateio
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Umraniye Egitim ve Arastirma Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: