Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Study Purpose

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian. 2. Subjects must have a weight of ≥ 20 kg. 3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening. 4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
  • - PASI score ≥ 12; and.
  • - Body surface area (BSA) ≥ 10%; and.
  • - sPGA ≥ 3 (moderate to severe) 5.
Disease inadequately controlled by or inappropriate for topical therapy for psoriasis. 6. Candidate for systemic therapy or phototherapy.

Exclusion Criteria:

1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline. 2. Psoriasis flare or rebound within 4 weeks prior to Screening. 3. Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent. 4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline. 5. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis. a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol) Exceptions*: i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions. *Subjects should not use these topical treatments within 24 hours prior to the clinic visit. b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03701763
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, Czechia, France, Israel, Italy, Netherlands, Russian Federation, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Additional Details

Treatment will be assigned by weight with subjects 20 kg to < 50 kg receiving apremilast 20 mg BID or placebo BID and subjects ≥ 50 kg receiving apremilast 30 mg BID or placebo BID. Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and extension phase will be able to enter the Long-term study. Subjects not entering the Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after last dose of study drug.

Arms & Interventions

Arms

Experimental: Administration of Apremilast (CC-10004) - 20mg

Apremilast 20mg Twice Daily (BID)

Experimental: Administration of Apremilast (CC-10004) - 30mg

Apremilast 30mg Twice Daily (BID)

Placebo Comparator: Administration of Placebo

Placebo tablet Twice Daily (BID)

Interventions

Drug: - Apremilast (CC-10004)

Apremilast (CC-10004)

Other: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama Birmingham

Birmingham, Alabama, 35233

Johnson Dermatology Clinic, Fort Smith, Arkansas

Status

Recruiting

Address

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916

Zenith Research Inc., Beverly Hills, California

Status

Recruiting

Address

Zenith Research Inc.

Beverly Hills, California, 90212

First OC Dermatology, Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology

Fountain Valley, California, 92708

Stanford University, Palo Alto, California

Status

Recruiting

Address

Stanford University

Palo Alto, California, 94304

Coastal Family Dermatology, San Luis Obispo, California

Status

Recruiting

Address

Coastal Family Dermatology

San Luis Obispo, California, 93401

California Dermatology Institute, Thousand Oaks, California

Status

Recruiting

Address

California Dermatology Institute

Thousand Oaks, California, 91320

Solutions Through Advanced Research Inc, Jacksonville, Florida

Status

Recruiting

Address

Solutions Through Advanced Research Inc

Jacksonville, Florida, 32256

Glick Skin Institute Clinical Research, Margate, Florida

Status

Recruiting

Address

Glick Skin Institute Clinical Research

Margate, Florida, 33063

University of Miami Hospital, Miami, Florida

Status

Recruiting

Address

University of Miami Hospital

Miami, Florida, 33136

Ciocca Dermatology, Miami, Florida

Status

Recruiting

Address

Ciocca Dermatology

Miami, Florida, 33173

Tampa, Florida

Status

Recruiting

Address

University of South Florida Health Morsani Center for Advanced Healthcare

Tampa, Florida, 33612

Skin Care Physicians of Georgia, Macon, Georgia

Status

Recruiting

Address

Skin Care Physicians of Georgia

Macon, Georgia, 31217

Dawes Fretzin Dermatology Group Inc, Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Dermatology Group Inc

Indianapolis, Indiana, 46256

ActivMed Practices and Research Inc, Beverly, Massachusetts

Status

Recruiting

Address

ActivMed Practices and Research Inc

Beverly, Massachusetts, 01915

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

J Woodson Dermatology and Associates Ltd, Henderson, Nevada

Status

Recruiting

Address

J Woodson Dermatology and Associates Ltd

Henderson, Nevada, 89052

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766

Montefiore Medical Center, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center

Bronx, New York, 10467

Forest Hills Dermatology Group, Forest Hills, New York

Status

Recruiting

Address

Forest Hills Dermatology Group

Forest Hills, New York, 11375

Wright State Physicians, Fairborn, Ohio

Status

Recruiting

Address

Wright State Physicians

Fairborn, Ohio, 45324

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Arlington Research Center, Arlington, Texas

Status

Recruiting

Address

Arlington Research Center

Arlington, Texas, 76011

Driscoll Childrens Hospital, Corpus Christi, Texas

Status

Recruiting

Address

Driscoll Childrens Hospital

Corpus Christi, Texas, 78411

Modern Research Associates PLLC, Dallas, Texas

Status

Completed

Address

Modern Research Associates PLLC

Dallas, Texas, 75231

Mosaic Dermatology, Houston, Texas

Status

Recruiting

Address

Mosaic Dermatology

Houston, Texas, 77065

Texas Dermatology and Laser Specialists, San Antonio, Texas

Status

Recruiting

Address

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218

Jordan Valley Dermatology Center, West Jordan, Utah

Status

Recruiting

Address

Jordan Valley Dermatology Center

West Jordan, Utah, 84088

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53715

Childrens Hospital of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

Brussels, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire Saint Pierre

Brussels, , 1000

Cliniques Universitaires St Luc, Bruxelles, Belgium

Status

Recruiting

Address

Cliniques Universitaires St Luc

Bruxelles, , 1200

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Gent

Gent, , 9000

Kirk Barber Research, Calgary, Alberta, Canada

Status

Recruiting

Address

Kirk Barber Research

Calgary, Alberta, T2G 1B1

Stollery Children's Hospital, Edmonton, Alberta, Canada

Status

Recruiting

Address

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7

Enverus Medical Research, Surrey, British Columbia, Canada

Status

Completed

Address

Enverus Medical Research

Surrey, British Columbia, V3R 6A7

Winnipeg Clinic Dermatology Research, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2

Karma Clinical Trials, Saint John's, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Karma Clinical Trials

Saint John's, Newfoundland and Labrador, A1A 4Y3

AvantDerm, Toronto, Ontario, Canada

Status

Recruiting

Address

AvantDerm

Toronto, Ontario, M5A 3R6

CHU Saint-Justine, Montreal, Quebec, Canada

Status

Recruiting

Address

CHU Saint-Justine

Montreal, Quebec, H3T 1C5

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia

Status

Recruiting

Address

Fakultni nemocnice Hradec Kralove

Hradec Kralove, , 500 05

Fakultni nemocnice Kralovske Vinohrady, Praha 1, Czechia

Status

Recruiting

Address

Fakultni nemocnice Kralovske Vinohrady

Praha 1, , 110 00

Argenteuil, France

Status

Recruiting

Address

Centre Hospitalier Victor Dupouy Argenteuil

Argenteuil, , 95107

Centre Hospitalier Universitaire Lyon, Bron cedex, France

Status

Recruiting

Address

Centre Hospitalier Universitaire Lyon

Bron cedex, , 69677

Cabinet du Docteur Ruer-Mulard Mireille, Martigues, France

Status

Recruiting

Address

Cabinet du Docteur Ruer-Mulard Mireille

Martigues, , 13500

Hotel Dieu CHU Nantes, Nantes, France

Status

Recruiting

Address

Hotel Dieu CHU Nantes

Nantes, , 44093

Centre Hospitalier Universitaire de Nice, Nice, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nice

Nice, , 06202

Hopital Necker, Paris Cedex 15, France

Status

Recruiting

Address

Hopital Necker

Paris Cedex 15, , 75015

Quimper, France

Status

Recruiting

Address

Centre Hospitalier de Cornouaille - Hopital Laennec

Quimper, , 29018

CHU Saint Etienne Hopital Nord, Saint-Priest En Jarrez, France

Status

Recruiting

Address

CHU Saint Etienne Hopital Nord

Saint-Priest En Jarrez, , 42055

Toulouse Cedex 9, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse Cedex 9, , 31059

Centre Hospitalier de Valence, Valence, France

Status

Recruiting

Address

Centre Hospitalier de Valence

Valence, , 26000

Soroka University Medical Center, Bear-Sheva, Israel

Status

Recruiting

Address

Soroka University Medical Center

Bear-Sheva, , 84101

Chaim Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Chaim Sheba Medical Center

Ramat Gan, , 5262000

Bologna, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi

Bologna, , 40138

Cagliari, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria di Cagliari

Cagliari, , 09124

Milano, Italy

Status

Recruiting

Address

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milano, , 20122

Napoli, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Federico II

Napoli, , 80131

Azienda Ospedaliera di Padova, Padova, Italy

Status

Recruiting

Address

Azienda Ospedaliera di Padova

Padova, , 35128

Reggio Emilia, Italy

Status

Recruiting

Address

Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova

Reggio Emilia, , 42123

Policlinico Tor Vergata, Roma, Italy

Status

Terminated

Address

Policlinico Tor Vergata

Roma, , 00133

Roma, Italy

Status

Recruiting

Address

Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

Roma, , 00144

Radboud university medical center, NIjmegen, Netherlands

Status

Recruiting

Address

Radboud university medical center

NIjmegen, ,

Altai State Medical University, Barnaul, Russian Federation

Status

Recruiting

Address

Altai State Medical University

Barnaul, , 656038

Chelyabinsk, Russian Federation

Status

Recruiting

Address

Chelyabinsk Regional Clinical Skin and Venereal Dispensary

Chelyabinsk, , 454092

Ekaterinburg, Russian Federation

Status

Recruiting

Address

Ural Scientific Research Institute of Dermatovenereology and Immunopathology

Ekaterinburg, , 620076

Kazan, Russian Federation

Status

Recruiting

Address

Republican Clinical Dermatology and Venerology Dispensary

Kazan, , 420004

Krasnodar, Russian Federation

Status

Recruiting

Address

Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

Krasnodar, , 350020

Moscow, Russian Federation

Status

Recruiting

Address

State Scientific Center for Dermatovenereology and Cosmetology

Moscow, , 107076

Russian Children's Clinical Hospital, Moscow, Russian Federation

Status

Recruiting

Address

Russian Children's Clinical Hospital

Moscow, , 117997

Moscow, Russian Federation

Status

Recruiting

Address

Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

Moscow, , 119071

Moscow, Russian Federation

Status

Recruiting

Address

National Medical Research Center for Children's Health

Moscow, , 119991

LLC Medical Center Zdorovaya Semiya, Novosibirsk, Russian Federation

Status

Recruiting

Address

LLC Medical Center Zdorovaya Semiya

Novosibirsk, , 630099

Saint Petersburg, Russian Federation

Status

Recruiting

Address

Pierre Wolkenshtein Skin Diseases Clinic LLC

Saint Petersburg, , 191123

LLC PiterKlinika, Saint Petersburg, Russian Federation

Status

Recruiting

Address

LLC PiterKlinika

Saint Petersburg, , 196158

Saint Petesburg, Russian Federation

Status

Recruiting

Address

St. Petersburg State Pediatric Medical University

Saint Petesburg, , 194100

Bashkiria State Medical University, Ufa, Russian Federation

Status

Recruiting

Address

Bashkiria State Medical University

Ufa, , 450008

Alicante, Comunidad Valenciana, Spain

Status

Recruiting

Address

Hospital General Universitario de Alicante

Alicante, Comunidad Valenciana, 03010

Badalona, Spain

Status

Recruiting

Address

Hospital Universitari Germans Trias i Pujol Can Ruti

Badalona, , 08916

Hospital Sant Joan de Deu, Barcelona, Spain

Status

Recruiting

Address

Hospital Sant Joan de Deu

Barcelona, , 08950

Hospital Puerta del Mar, Cadiz, Spain

Status

Completed

Address

Hospital Puerta del Mar

Cadiz, , 11009

Hospital Universitario Reina Sofia, Cordoba, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Cordoba, , 14001

Madrid, Spain

Status

Recruiting

Address

Hospital General Universitario Gregorio Maranon

Madrid, , 28007

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Nino Jesus

Madrid, , 28009

Hospital 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital 12 de Octubre

Madrid, , 28041

Hospital La Paz, Madrid, Spain

Status

Recruiting

Address

Hospital La Paz

Madrid, , 28046

Complexo Hospitalario De Pontevedra, Pontevedra, Spain

Status

Recruiting

Address

Complexo Hospitalario De Pontevedra

Pontevedra, , 36001

Hospital Marques de Valdecilla, Satander, Spain

Status

Recruiting

Address

Hospital Marques de Valdecilla

Satander, , 39008

Sevilla, Spain

Status

Completed

Address

Hospital Universitario Virgen del Rocio - PPDS

Sevilla, , 41013

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