NCT05767047 A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
| NCT ID | NCT05767047 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amgen |
| Condition | Behçet's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2036-03-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 48 participants in total. It began in 2023-03-23 with a primary completion date of 2036-03-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT05767047 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Behçet's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05767047 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 48 participants.
Is NCT05767047 currently recruiting?
Yes, NCT05767047 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT05767047 trial being conducted?
This trial is being conducted at Thessaloniki, Greece, Kfar Saba, Israel, Valencia, Spain, Madrid, Spain and 3 additional locations.
Who is sponsoring the NCT05767047 clinical trial?
NCT05767047 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 48 participants.