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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers who finished the earlier apremilast study (Study 20190530 or Study 20190529) for mouth ulcers from Behçet's disease or for juvenile psoriatic arthritis.
- Age
- 5 Years to 18 Years
- Sex
- All sexes can join.
- Disease stage
- Mouth ulcers linked to Behçet's disease, or active juvenile psoriatic arthritis.
- Earlier treatment
- Must have completed Week 52 on treatment in the earlier core study.
Main reasons for not taking part
- A "yes" answer to any question on the C-SSRS at the Week 52 visit of the core study
- Surgery or other procedures planned that would interrupt the study
- Women able to have children who are unwilling to use the study's birth control method
- Women planning to become pregnant, or with a positive pregnancy test at Week 0
- Known sensitivity to any product given in the study
Read by machine on 12 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.