The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Oral tablet
Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 up to approximately 285 days
Growth and Development as Assessed by Height
Time frame: Day 1 up to approximately 285 days
Growth and Development as Assessed by Weight
Time frame: Day 1 up to approximately 285 days
Growth and Development as Assessed by Body Mass Index (BMI)
Time frame: Day 1 up to approximately 285 days
Columbia-Suicide Severity rating Scale (C-SSRS)
Time frame: Day 1 to Day 225
Tanner Staging of Sexual Maturity
Time frame: Day 1 and Day 225
Number of Participants With Psoriasis Flare
Time frame: Up to approximately 285 days
Number of Participants With Psoriasis Rebound
Time frame: Up to approximately 285 days
Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries
Time frame: Day 1 to Day 225
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time frame: Up to approximately 225 days
Number of Participants with Clinically Significant Changes in Vital Signs
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Affiliated Dermatology
Scottsdale, Arizona, United States
Clear Dermatology
Scottsdale, Arizona, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
Avance Clinical Trials
Laguna Niguel, California, United States
University of California Irvine
Orange, California, United States
MedDerm Associates
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
California Dermatology Institute
Thousand Oaks, California, United States
Pediatric Skin Research LLC
Coral Gables, Florida, United States
...and 20 more locations
Time frame: Up to approximately 285 days