An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

Study Purpose

This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 332 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF. 3. Subject must have a diagnosis of moderate or severe psoriasis of the genital area at Screening and Baseline. 4. Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline. 5. Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening and Baseline. 6. Subject must have been inadequately controlled with or intolerant of topical therapy, or topical therapy is inappropriate for the treatment of psoriasis affecting the genital area. 7. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. 8. Subject must meet laboratory criteria

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study. 2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3. Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening. 4. Subject has active tuberculosis (TB) or a history of incompletely treated TB. 5. Subject has prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 6. Subject has current or planned therapies that may have a possible effect on psoriasis of the body and/or genital area during the course of the treatment phase of the trial 7. Subject had prior treatment with apremilast.

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.

NCT03777436
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.

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry
Overall Status Recruiting
Countries Belgium, Canada, France, Germany, Italy, Puerto Rico, United States
Conditions

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

Psoriasis
Additional Details

The study will consist of four phases:

  • - Screening Phase - up to 35 days - Double-blind Placebo-controlled Phase - Weeks 0 to 16 - Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.
  • - Apremilast Extension Phase - Weeks 16 to 32 - All subjects will be switched to (or continue with) apremilast 30 mg BID.
All subjects will maintain this dosing through Week 32.
  • - Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.

Arms & Interventions

Arms

Experimental: Arm A- Apremilast with Placebo

Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks

Experimental: Arm B - Apremilast 30 mg

All subjects will receive apremilast 30 mg tablets orally twice daily after the Week 16 Visit through the end of the Apremilast Extension Phase of the study

Interventions

Drug: - Apremilast

Oral

Other: - Placebo

Oral

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 at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0111

First OC Dermatology, Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology

Fountain Valley, California, 92708

Clinical Science Institute, Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute

Santa Monica, California, 90404

Glick Skin Institute Clinical Research, Margate, Florida

Status

Recruiting

Address

Glick Skin Institute Clinical Research

Margate, Florida, 33063

International Dermatology Research, Miami, Florida

Status

Recruiting

Address

International Dermatology Research

Miami, Florida, 33144

Skin Care Physicians of Georgia, Macon, Georgia

Status

Recruiting

Address

Skin Care Physicians of Georgia

Macon, Georgia, 31217

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

Adult and Pediatric Dermatology, Overland Park, Kansas

Status

Recruiting

Address

Adult and Pediatric Dermatology

Overland Park, Kansas, 66211

ActivMed Practices & Research Inc, Beverly, Massachusetts

Status

Recruiting

Address

ActivMed Practices & Research Inc

Beverly, Massachusetts, 01915

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

J. Woodson Dermatology and Associates, Henderson, Nevada

Status

Recruiting

Address

J. Woodson Dermatology and Associates

Henderson, Nevada, 89502

Las Vegas Dermatology, Las Vegas, Nevada

Status

Recruiting

Address

Las Vegas Dermatology

Las Vegas, Nevada, 89144

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

ActivMed, Portsmouth, New Hampshire

Status

Recruiting

Address

ActivMed

Portsmouth, New Hampshire, 03801

Stony Brook Dermatology Associates, Stony Brook, New York

Status

Recruiting

Address

Stony Brook Dermatology Associates

Stony Brook, New York, 11790

Dermatology Consulting Services, High Point, North Carolina

Status

Recruiting

Address

Dermatology Consulting Services

High Point, North Carolina, 27262

Oakview Dermatology, Athens, Ohio

Status

Recruiting

Address

Oakview Dermatology

Athens, Ohio, 45701

Ohio State University Medical Center, Columbus, Ohio

Status

Recruiting

Address

Ohio State University Medical Center

Columbus, Ohio, 43210

Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University OHSU

Portland, Oregon, 97239

Paddington Testing Co., Inc., Philadelphia, Pennsylvania

Status

Recruiting

Address

Paddington Testing Co., Inc.

Philadelphia, Pennsylvania, 19103

Clinical Partners, LLC, Johnston, Rhode Island

Status

Recruiting

Address

Clinical Partners, LLC

Johnston, Rhode Island, 02919

Austin Institute for Clinical Research, Pflugerville, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

Center for Clinical Studies, Webster, Texas

Status

Recruiting

Address

Center for Clinical Studies

Webster, Texas, 77598

Virginia Clinical Research Inc, Norfolk, Virginia

Status

Recruiting

Address

Virginia Clinical Research Inc

Norfolk, Virginia, 23502

Bellevue Dermatology Clinic, Bellevue, Washington

Status

Recruiting

Address

Bellevue Dermatology Clinic

Bellevue, Washington, 98004

Dermatology Center for Skin Health, Morgantown, West Virginia

Status

Recruiting

Address

Dermatology Center for Skin Health

Morgantown, West Virginia, 26505

International Sites

Brussels, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire Saint-Pierre

Brussels, , 1000

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc

Brussels, , 1200

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Skincare Studio, St. John's, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Skincare Studio

St. John's, Newfoundland and Labrador, A1E 1V4

Guenther Dermatology Research Centre, London, Ontario, Canada

Status

Recruiting

Address

Guenther Dermatology Research Centre

London, Ontario, N6A 3H7

Lynderm Research, Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research

Markham, Ontario, L3P 1X2

K. Papp Clinical Research, Waterloo, Ontario, Canada

Status

Recruiting

Address

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4

Dre Angelique Gagne-Henley M.D. Inc., Saint-Jerome, Quebec, Canada

Status

Recruiting

Address

Dre Angelique Gagne-Henley M.D. Inc.

Saint-Jerome, Quebec, J7Z 7E2

Hopital Saint Andre' CHU de Bordeaux, Bordeaux, France

Status

Recruiting

Address

Hopital Saint Andre' CHU de Bordeaux

Bordeaux, , 33075

Hopital Claude Huriez CHRU Lille, Lille cedex, France

Status

Recruiting

Address

Hopital Claude Huriez CHRU Lille

Lille cedex, , 59037

CHU de Nice Archet I, Nice, France

Status

Recruiting

Address

CHU de Nice Archet I

Nice, , 06202

Larrey University Hospital, Toulouse, France

Status

Recruiting

Address

Larrey University Hospital

Toulouse, , 31000

Berlin, Germany

Status

Recruiting

Address

ISA - Interdisciplinary Study Association GmbH

Berlin, , 10789

Universitaetsklinikum Bonn, Bonn, Germany

Status

Recruiting

Address

Universitaetsklinikum Bonn

Bonn, , 53127

Duesseldorf, Germany

Status

Not yet recruiting

Address

Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf

Duesseldorf, , 40225

Hautklinik Universitatsklinikum Erlangen, Erlangen, Germany

Status

Recruiting

Address

Hautklinik Universitatsklinikum Erlangen

Erlangen, , 91054

Universitatsklinikum Frankfurt, Frankfurt, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt, , 60590

Lübeck, Germany

Status

Recruiting

Address

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, , 23538

Mainz, Germany

Status

Recruiting

Address

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , 55131

Ospedali Riuniti di Ancona, Ancona, Italy

Status

Recruiting

Address

Ospedali Riuniti di Ancona

Ancona, , 60126

Presidio Ospedaliero della Misericordia, Grosseto, Italy

Status

Recruiting

Address

Presidio Ospedaliero della Misericordia

Grosseto, , 58100

L'Aquila, Italy

Status

Recruiting

Address

Azienda Sanitaria Locale 1 - Ospedale Regionale San Salvatore

L'Aquila, , 67100

Universita degli Studi di Padova, Padova, Italy

Status

Not yet recruiting

Address

Universita degli Studi di Padova

Padova, , 35128

Reggio Di Calabria, Italy

Status

Recruiting

Address

Azienda Ospedaliera Bianchi Melacrino Morelli

Reggio Di Calabria, , 89124

Terracina, Italy

Status

Recruiting

Address

Universita degli Studi di Roma La Sapienza - Ospedale A. Fiorini di Terracina

Terracina, , 04019

Trieste, Italy

Status

Recruiting

Address

Azienda Sanitaria Universitaria Integrata di Trieste

Trieste, , 34125

GCM Medical Group, PSC, San Juan, Puerto Rico

Status

Not yet recruiting

Address

GCM Medical Group, PSC

San Juan, , 00917

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