Recruitment Complete
Sponsor ID
CC-10004-PPSO-004

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

Sponsor ID
CC-10004-PPSO-004
Clinicaltrials.gov ID
NCT04175613
EUCTIS ID
N/A
EudraCT ID
2019-003497-13

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
160
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

Static Physician Global Assessment (sPGA)

Timeframe: Collected at each study visit throughout the life of the study - up to 4 years

Locations

Location
Status
Contact Us
Location
Dawes Fretzin Dermatology Group Inc
Indianapolis, IN, United States, 46256
Status
Recruiting
Location
Solutions Through Advanced Research Inc
Jacksonville, FL, United States, 32256
Status
Completed
Location
Hopsital Germans Trias I Pujol
Badalona, Spain, 08916
Status
Completed
Location
California Dermatology Institute
Thousand Oaks, CA, United States, 91320
Status
Completed
Location
First OC Dermatology
Irvine, CA, United States, 92697
Status
Completed
Location
Johnson Dermatology Clinic
Fort Smith, AR, United States, 72916
Status
Recruiting
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