A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Recruiting
Phase 3
Interventional Study
Behçet's Disease
Juvenile Psoriatic Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 5 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 48 (estimated)
- Sponsor
- Amgen · Industry
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About This Trial
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.
Trial Locations
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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 …
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