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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: Up to approximately 4 years
Columbia-Suicide Severity Rating Scale (C-SSRS)
Questionnaire to monitor depression, suicidal thoughts and behavior
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
Weight of patients treated with Apremilast
Body weight in kg
Time frame: 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
BMI (combined outcome of weight and height in the form of kg/m\^2)
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
Height patients treated with Apremilast
Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
Assessment of sexual maturity
Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized
Time frame: Collected every 52 weeks throughout the life of the study - up to 4 years
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Phoenix Childrens Hospital
Phoenix, Arizona, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
First OC Dermatology
Irvine, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
California Dermatology Institute
Thousand Oaks, California, United States
Solutions Through Advanced Research Inc
Jacksonville, Florida, United States
Ciocca Dermatology
Miami, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Dawes Fretzin Dermatology Group Inc
Indianapolis, Indiana, United States
Wright State Physicians
Fairborn, Ohio, United States
...and 40 more locations
Static Physician Global Assessment (sPGA)
is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.
Time frame: Collected at each study visit throughout the life of the study - up to 4 years