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

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

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: February 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Psoriatic
• Behcet Syndrome
• Behçet's Disease
• Juvenile Psoriatic Arthritis
• Oral Ulcer

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	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

External Links

•   AmgenTrials clinical trials website