A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
NCT ID: NCT05767047
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
48 participants
INTERVENTIONAL
2023-03-23
2036-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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Apremilast
Participants with a weight between ≥ 12 kg to \< 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to \< 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.
Apremilast
Oral tablets or liquid suspension
Interventions
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Apremilast
Oral tablets or liquid suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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General Hospital of Thessaloniki Ippokrateio
Thessaloniki, , Greece
Meir Medical Center
Kfar Saba, , Israel
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2022-003024-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503433-21
Identifier Type: OTHER
Identifier Source: secondary_id
20190531
Identifier Type: -
Identifier Source: org_study_id
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