A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)
Phase 3 – large-scale trial before approval
Conditions:
Juvenile psoriatic arthritis
Sponsor: Amgen Inc.
trial.available_in:
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Overview
Trial status: Authorised
Change in subject's assessment of pain (a), Number of participants achieving ACR Pedi 20/50/70/90 (a), Change in Childhood Heath Assessment Questionnaire (CHAQ) (a), Change in Juvenile Arthritis Disease Activity Score (JADAS) (a), Refer to protocol for fully list of secondary endpoints., PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a), Number of participants who experience PsA flares (a)
Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16
Description
Change in subject's assessment of pain (a), Number of participants achieving ACR Pedi 20/50/70/90 (a), Change in Childhood Heath Assessment Questionnaire (CHAQ) (a), Change in Juvenile Arthritis Disease Activity Score (JADAS) (a), Refer to protocol for fully list of secondary endpoints., PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a), Number of participants who experience PsA flares (a)
Who can participate
Age group: 0-17 years
Gender: Female, Male
Target enrollment: 51 participants
Interventions
Apremilast
Drug
Apremilast
Drug
Apremilast
Drug
Apremilast placebo product is supplied to the clinic as 10, 20 and 30 mg tablets and 5 mg/mL oral solution. The placebo product is the same as the drug product formulation except there is no active apremilast.
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