A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis
Study Details
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.
The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.
Protocol Summary
Adverse Events (AEs)
Timeframe: Up to approximately 4 years
Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: Collected at each study visit throughout the life of the study - up to 4 years
Weight of patients treated with Apremilast
Timeframe: Collected at each study visit throughout the life of the study - up to 4 years
Mean body mass index of the patient treated with Apremilast
Timeframe: Collected at each study visit throughout the life of the study - up to 4 years
Height patients treated with Apremilast
Timeframe: Collected at each study visit throughout the life of the study - up to 4 years
Assessment of sexual maturity
Timeframe: Collected every 52 weeks throughout the life of the study - up to 4 years
Static Physician Global Assessment (sPGA)
Timeframe: Collected at each study visit throughout the life of the study - up to 4 years