Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05767047
Other study ID # 20190531
Secondary ID 2022-003024-41
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 23, 2023
Est. completion date December 29, 2032

Study information

Verified date May 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Apremilast
Oral tablets or liquid suspension

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

Greece,  Israel,  Spain,  Turkey, 

Outcome

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
See also
  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