Behçet's Disease, Juvenile Psoriatic Arthritis
Conditions
Keywords
Oral Ulcers, Behçet's Disease, Juvenile Psoriatic Arthritis, Apremilast, AMG 407, Otezla
Brief summary
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
DRUGApremilast
Oral tablets or liquid suspension
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | Up to approximately 4 years | Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. |
| Columbia-Suicide Severity rating Scale (C-SSRS) | Up to approximately 4 years | A questionnaire used to assess suicide risk. |
| Tanner Staging | Up to approximately 4 years | Tanner Staging of sexual development assessment will be used to assess sexual maturity. |
| Change from Baseline in Body Weight | Up to approximately 4 years | — |
| Change from Baseline in Height | Up to approximately 4 years | — |
| Change from Baseline in Body Mass Index (BMI) | Up to approximately 4 years | — |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to approximately 4 years | — |
| Number of Participants with Clinically Significant Changes in Laboratory Parameters | Up to approximately 4 years | — |
Countries
Greece, Israel, Spain, Turkey (Türkiye)
Contacts
Primary ContactAmgen Call Center
Outcome results
None listed