Long-term safety of apremilast in children with Behçet's disease or juvenile psoriatic arthritis
Checks long-term safety of apremilast in children with mouth ulcers or juvenile psoriatic arthritis.
Plain-language title generated from the registry record
Registry title: A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Key facts
- Where
- Thessaloniki, GreeceSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 18 years old?
Source: NCT05767047, who can take part
Where in Greece
- General Hospital of Thessaloniki "IPPOKRATEIO"Thessaloniki, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT05767047
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Scheduled surgery or other interventions that would interrupt study participation; Answer "yes" to any question on C-SSRS at Week 52 visit of core study; 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.