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

Phase 3

Recruiting

• Conditions: Behçet's Disease; Juvenile Psoriatic Arthritis
• Interventions: Drug: Apremilast

• Registration Number: NCT05767047
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-14
• Study Start: 2023-03-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2036-03-28
• Study Completion: 2036-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apremilast	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.

Primary Outcome Measures

Name	Time	Method
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.
Number of Participants with Clinically Significant Changes in Vital Signs	Up to approximately 4 years
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.
Change from Baseline in Body Weight	Up to approximately 4 years
Change from Baseline in Body Mass Index (BMI)	Up to approximately 4 years
Change from Baseline in Height	Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Laboratory Parameters	Up to approximately 4 years

Trial Locations

Locations (6)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

General Hospital of Thessaloniki Ippokrateio; 🇬🇷 Thessaloniki, Greece

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Umraniye Egitim ve Arastirma Hastanesi; 🇹🇷 Istanbul, Turkey

Istanbul Universitesi Cerrahpasa Tip Fakultesi; 🇹🇷 Istanbul, Turkey