Recruitment Complete
Sponsor ID
20200196
A Study of Apremilast in Pediatric Participants in Children with Mild to Moderate Plaque Psoriasis
Study Details
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.
Protocol Summary
Primary Outcome Measures
Number of Participants With Treatment-emergent Adverse Events
Timeframe: Day 1 up to approximately 285 days
Secondary Outcome Measures
Growth and Development as Assessed by Height
Timeframe: Day 1 up to approximately 285 days
Growth and Development as Assessed by Weight
Timeframe: Day 1 up to approximately 285 days
Growth and Development as Assessed by Body Mass Index (BMI)
Timeframe: Day 1 up to approximately 285 days
Columbia-Suicide Severity rating Scale (C-SSRS)
Timeframe: Day 1 to Day 225
Tanner Staging of Sexual Maturity
Timeframe: Day 1 and Day 225
Number of Participants With Psoriasis Flare
Timeframe: Up to approximately 285 days
Number of Participants With Psoriasis Rebound
Timeframe: Up to approximately 285 days
Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries
Timeframe: Day 1 to Day 225
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Timeframe: Up to approximately 225 days
Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to approximately 285 days
Locations
Location
California Dermatology Institute
Thousand Oaks, CA, United States, 91320
Status
Recruiting
Location
Ciocca Dermatology
Miami, FL, United States, 33173
Status
Recruiting
Location
Dermatology Research Center of Oklahoma, PLLC
Tulsa, OK, United States, 74132
Status
Terminated
Location
Stride Clinical Research LLC
Sugar Land, TX, United States, 77479
Status
Recruiting
Location
Studies in Dermatology LLC
Cypress, TX, United States, 77429
Status
Recruiting
Location
Clinical Science Institute
Santa Monica, CA, United States, 90404
Status
Terminated
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