A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the long-term safety of apremilast in participants 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.

Official Title
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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

Conditions
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Behçet's Disease, Juvenile Psoriatic Arthritis

Intervention / Treatment
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* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent / assent obtained Must have completed Week 52 on treatment on core study Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) 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 Not likely to be available to complete all protocol-required study visits

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apremilast<br>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. | Drug: Apremilast<br>* Oral tablets or liquid suspension<br>* Other names: CC-10004;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. | Up to approximately 4 years | 
| Columbia-Suicide Severity rating Scale (C-SSRS) | A questionnaire used to assess suicide risk. | Up to approximately 4 years | 
| Tanner Staging | Tanner Staging of sexual development assessment will be used to assess sexual maturity. | Up to approximately 4 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Ulcers, Behçet's Disease, Juvenile Psoriatic Arthritis, Apremilast, AMG 407, Otezla