Apremilast Study in Children with Active Juvenile Psoriatic Arthritis
Research type
Research Study
Full title
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)
IRAS ID
1004177
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2019-002788-88
Clinicaltrials.gov Identifier
Research summary
Juvenile Psoriatic Arthritis (JPsA) is a chronic inflammatory disease that is characterised by a rash, nail changes and eye inflammation. Juvenile Psoriatic Arthritis is similar to adult Psoriatic Arthritis however unlike adult Psoriatic Arthritis, inflammatory arthritis comes before skin psoriasis in about half of children making diagnosis challenging. There are no specific guidelines for treatment of Juvenile Psoriatic Arthritis; however, standard practice shows that the treatment is the same as for Juvenile Idiopathic Arthritis (JIA).
The primary aim of the study is to estimate the effectiveness of AMG407 compared with placebo in the treatment of Juvenile Psoriatic Arthritis in paediatric subjects 5 to <18 years of age. The total length of the study will be approximately 62 weeks, comprising of a 6 week screening phase and 52 week treatment phase. The first 16 weeks will be a double blind, placebo (a control) controlled phase, with subjects randomised in a 2:1 ratio on day 1 to oral AMG407 (tablet or liquid form) or placebo (tablet or liquid form). This will be followed by a 36 week AMG407 active treatment phase where all subjects will receive active drug. Then followed by a post treatment safety follow up phase, which is completed 30 days after last dose of IP.
AMG407 is an oral medicine which helps reduce inflammation within the cells. The benefit/risk profile of AMG407continues to be favourable in adult patients with Psoriatic Arthritis and it is thought that treatment with AMG407 in Juvenile Psoriatic Arthritis will provide similar benefit as seen in adult Psoriatic Arthritis
The study has an independent, external and unblinded Data Monitoring Committee, who will review data throughout the study to provide ongoing evaluations of subject safety.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0011
Date of REC Opinion
25 Feb 2022
REC opinion
Further Information Favourable Opinion