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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Amgen
Study ID
NCT04175613
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    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

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.

Key Dates

First listed
Nov 25, 2019
Start date
Dec 20, 2019
Status verified
Dec 2025
Primary completion
Oct 30, 2025
Completion
Dec 12, 2025

Study Design

Enrollment
160 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients treated with Apremilast
    Subjects with a weight between 20 kg to \< 50 kg will receive apremilast 20 mg BID and subjects with weight ≥ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight ≥ 50 kg, will be switched to apremilast 30 mg BID.

Primary Outcome Measure

Adverse Events (AEs) [ Time Frame: Up to approximately 4 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
Phoenix Childrens HospitalPhoenixArizona85016-
Johnson Dermatology ClinicFort SmithArkansas72916-
First OC DermatologyIrvineCalifornia92697-
Stanford University School of MedicinePalo AltoCalifornia94304-
California Dermatology InstituteThousand OaksCalifornia91320-
Solutions Through Advanced Research IncJacksonvilleFlorida32256-
Ciocca DermatologyMiamiFlorida33173-
Skin Care Physicians of GeorgiaMaconGeorgia31217-
Dawes Fretzin Dermatology Group IncIndianapolisIndiana46256-
Wright State PhysiciansFairbornOhio45324-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Driscoll Childrens HospitalSan AntonioTexas78218-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53715-1375-

Find similar trials in Phoenix, AZ

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Phoenix Childrens Hospital· Phoenix, AZJohnson Dermatology Clinic· Fort Smith, ARFirst OC Dermatology· Irvine, CAStanford University School of Medicine· Palo Alto, CACalifornia Dermatology Institute· Thousand Oaks, CASolutions Through Advanced Research Inc· Jacksonville, FL

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