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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

NCT04175613•Amgen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must satisfy the following criteria to be enrolled in the study:
•1. Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian.
•2. Subject must have a weight of ≥ 20 kg.
•3. Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.
•4. Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
•5. Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
•6. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
•7. All female subjects of childbearing potential (FCBP) must either practice abstinence from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and for at least 28 days after administration of the last dose of apremilast. For the purpose of this study, a female subject is considered of childbearing potential if she is ≥ 12 years old or has reached menarche, whichever occurred first.
•At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.
•Females of childbearing potential must have a negative pregnancy test at each visit. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
+5 more criteria

Exclusion Criteria

•The presence of any of the following will exclude a subject from enrollment:
•1. Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study.
•2. Subject has a condition that confounds the ability to interpret data from the study.
•3. Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
•4. Subject is pregnant or breastfeeding.
•5. Subject has guttate, erythrodermic, or pustular psoriasis.
•6. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
•7. Subject answers "Yes" to any question on the Columbia-Suicide Severity Rating Scale at Visit 16 of study CC-10004-PPSO-003.
•8. Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis.
•1. Conventional systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters)
+4 more criteria

Locations (50)

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Johnson Dermatology Clinic

Fort Smith, Arkansas, United States

First OC Dermatology

Irvine, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

California Dermatology Institute

Thousand Oaks, California, United States

Solutions Through Advanced Research Inc

Jacksonville, Florida, United States

Ciocca Dermatology

Miami, Florida, United States

Skin Care Physicians of Georgia

Macon, Georgia, United States

Dawes Fretzin Dermatology Group Inc

Indianapolis, Indiana, United States

Wright State Physicians

Fairborn, Ohio, United States

Key Dates

Start Date

December 20, 2019

Primary Completion Date

October 30, 2025

Completion Date

December 12, 2025

Last Updated

December 22, 2025

Enrollment

160

ACTUAL participants

Conditions

Psoriasis

Interventions

Apremilast

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments