Recruitment Complete
Sponsor ID
20200196

A Study of Apremilast in Pediatric Participants in Children with Mild to Moderate Plaque Psoriasis

Sponsor ID
20200196
Clinicaltrials.gov ID
NCT06088199
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
AMG 407
Type
Interventional
Masking
None (Open Label)
Enrollment
51
Additional Study Details

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
Status
Contact Us
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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