Behçet's Disease Clinical Trial
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
Verified date | May 2024 |
Source | Amgen |
Contact | Amgen Call Center |
Phone | 866-572-6436 |
medinfo[@]amgen.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 29, 2032 |
Est. primary completion date | December 29, 2032 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | General Hospital of Thessaloniki Ippokrateio | Thessaloniki | |
Israel | Meir Medical Center | Kfar Saba | |
Spain | Hospital Universitario Ramon y Cajal | Madrid | |
Spain | Hospital Universitari i Politecnic La Fe | Valencia | Comunidad Valenciana |
Turkey | Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | |
Turkey | Umraniye Egitim ve Arastirma Hastanesi | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Greece, Israel, Spain, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events | Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. | Up to approximately 4 years | |
Primary | Columbia-Suicide Severity rating Scale (C-SSRS) | A questionnaire used to assess suicide risk. | Up to approximately 4 years | |
Primary | Tanner Staging | Tanner Staging of sexual development assessment will be used to assess sexual maturity. | Up to approximately 4 years | |
Primary | Change from Baseline in Body Weight | Up to approximately 4 years | ||
Primary | Change from Baseline in Height | Up to approximately 4 years | ||
Primary | Change from Baseline in Body Mass Index (BMI) | Up to approximately 4 years | ||
Primary | Number of Participants with Clinically Significant Changes in Vital Signs | Up to approximately 4 years | ||
Primary | Number of Participants with Clinically Significant Changes in Laboratory Parameters | Up to approximately 4 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05545839 -
Transition to Adulthood Through Coaching and Empowerment in Rheumatology
|
N/A | |
Completed |
NCT05252533 -
A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis
|
Phase 1 | |
Completed |
NCT03031782 -
Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
|
Phase 3 | |
Active, not recruiting |
NCT03769168 -
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
|
Phase 3 | |
Recruiting |
NCT06100744 -
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
|
Phase 3 | |
Active, not recruiting |
NCT04527380 -
A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
|
Phase 3 |