A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apremilast.
- Who it may be relevant to
- Registry conditions: Behçet's Disease, Juvenile Psoriatic Arthritis. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece, Israel, Spain, Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Apremilast
Oral tablets or liquid suspension
Primary outcome measures
- Number of Participants with Adverse Events [Time frame: Up to approximately 4 years]
- Columbia-Suicide Severity rating Scale (C-SSRS) [Time frame: Up to approximately 4 years]
- Tanner Staging [Time frame: Up to approximately 4 years]
- Change from Baseline in Body Weight [Time frame: Up to approximately 4 years]
- Change from Baseline in Height [Time frame: Up to approximately 4 years]
- Change from Baseline in Body Mass Index (BMI) [Time frame: Up to approximately 4 years]
- Number of Participants with Clinically Significant Changes in Vital Signs [Time frame: Up to approximately 4 years]
- Number of Participants with Clinically Significant Changes in Laboratory Parameters [Time frame: Up to approximately 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 3 centers
- Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara
- Istanbul Universitesi Cerrahpasa Tip Fakultesi — Istanbul
- Umraniye Egitim ve Arastirma Hastanesi — Istanbul
Spain · 2 centers
- Hospital Universitari i Politecnic La Fe — Valencia
- Hospital Universitario Ramon y Cajal — Madrid
Greece · 1 center
- General Hospital of Thessaloniki Ippokrateio — Thessaloniki
Israel · 1 center
- Meir Medical Center — Kfar Saba
Identifiers
NCT: NCT05767047 · 20190531 · 2022-003024-41 · 2023-503433-21