Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

Study Purpose

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Recruitment Criteria

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

Accepts Healthy Volunteers
No

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.

Study Type
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 must be male or female, ≥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 mild to moderate plaque psoriasis at both Screening and Baseline. 4. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline. 5. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. 6. Subject must meet laboratory criteria. 7. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. 2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB. 4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease). 5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening. 6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial. 8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). 9. Subject had prior treatment with apremilast.

Trial Details

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.

Trial ID:
NCT03721172

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
Phase 3

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

Lead Sponsor
Celgene

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

Principal Investigator
Yao Wang, MD
Principal Investigator Affiliation Celgene Corporation

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

Agency Class
Industry
Overall Status Recruiting
Countries Canada, United States

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

Conditions
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.

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.

Dermatology Center for Skin Health, Morgantown, West Virginia

Status

Recruiting

Address

Dermatology Center for Skin Health

Morgantown, West Virginia, 26505

Dermatology of Seattle, Seattle, Washington

Status

Not yet recruiting

Address

Dermatology of Seattle

Seattle, Washington, 98168

Virginia Clinical Research Inc, Norfolk, Virginia

Status

Recruiting

Address

Virginia Clinical Research Inc

Norfolk, Virginia, 23502

University of Utah MidValley Dermatology, Murray, Utah

Status

Not yet recruiting

Address

University of Utah MidValley Dermatology

Murray, Utah, 84107

Center for Clinical Studies, Webster, Texas

Status

Recruiting

Address

Center for Clinical Studies

Webster, Texas, 77598

Austin Institute for Clinical Research, Pflugerville, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

Charleston, South Carolina

Status

Recruiting

Address

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

Clinical Partners, LLC, Johnston, Rhode Island

Status

Recruiting

Address

Clinical Partners, LLC

Johnston, Rhode Island, 02919

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Temple University - Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140

Wright State Physicians, Fairborn, Ohio

Status

Recruiting

Address

Wright State Physicians

Fairborn, Ohio, 45324

Columbus, Ohio

Status

Recruiting

Address

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Not yet recruiting

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27104

Chapel Hill, North Carolina

Status

Not yet recruiting

Address

University of North Carolina - Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10003

Bronx, New York

Status

Not yet recruiting

Address

Albert Einstein College of Medicine - Montefiore Medical Center

Bronx, New York, 10467

East Windsor, New Jersey

Status

Recruiting

Address

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

JDR Dermatology Research, LLC, Las Vegas, Nevada

Status

Recruiting

Address

JDR Dermatology Research, LLC

Las Vegas, Nevada, 89148

Central Dermatology, Saint Louis, Missouri

Status

Recruiting

Address

Central Dermatology

Saint Louis, Missouri, 63117

Minnesota Clinical Study Center, Fridley, Minnesota

Status

Recruiting

Address

Minnesota Clinical Study Center

Fridley, Minnesota, 55432

Detroit, Michigan

Status

Recruiting

Address

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114-2517

ActivMed Practices & Research Inc, Beverly, Massachusetts

Status

Recruiting

Address

ActivMed Practices & Research Inc

Beverly, Massachusetts, 01915

Lawrence Green, MD, LLC, Rockville, Maryland

Status

Recruiting

Address

Lawrence Green, MD, LLC

Rockville, Maryland, 20850

Derm Associates, Rockville, Maryland

Status

Recruiting

Address

Derm Associates

Rockville, Maryland, 20850

Clinical Trials Management LLC, Metairie, Louisiana

Status

Recruiting

Address

Clinical Trials Management LLC

Metairie, Louisiana, 70006

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256

Gwinnett Clinical Research Center, Inc., Snellville, Georgia

Status

Recruiting

Address

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078

MedaPhase INC, Newnan, Georgia

Status

Recruiting

Address

MedaPhase INC

Newnan, Georgia, 30263

Atlanta, Georgia

Status

Recruiting

Address

Medical Dermatology Specialists, Inc. - Advanced Medical Research

Atlanta, Georgia, 30328

Alpharetta, Georgia

Status

Recruiting

Address

Atlanta Dermatology, Vein and Research Center, PC

Alpharetta, Georgia, 30022

Tampa, Florida

Status

Recruiting

Address

University of South Florida - Carol and Frank Morsani Center for Advanced Health Care

Tampa, Florida, 33612

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

Miami, Florida

Status

Recruiting

Address

Center for Clinical and Cosmetic Research

Miami, Florida, 33180

International Dermatology Research, Miami, Florida

Status

Recruiting

Address

International Dermatology Research

Miami, Florida, 33144

Coral Gables, Florida

Status

Recruiting

Address

Florida Academic Centers Research and Education

Coral Gables, Florida, 33134

Total Vein and Skin, LLC, Boynton Beach, Florida

Status

Recruiting

Address

Total Vein and Skin, LLC

Boynton Beach, Florida, 33437

Aurora, Colorado

Status

Not yet recruiting

Address

University of Colorado Hospital - Dermatology Clinic

Aurora, Colorado, 80045

Santa Monica, California

Status

Recruiting

Address

Dermatology Institute and Skin Care Center

Santa Monica, California, 90404

San Francisco, California

Status

Recruiting

Address

University of California San Francisco Psoriasis and Skin Treatment Center

San Francisco, California, 94118

TCR Medical Corporation, San Diego, California

Status

Recruiting

Address

TCR Medical Corporation

San Diego, California, 92123

Dermatology Research Associates, Los Angeles, California

Status

Recruiting

Address

Dermatology Research Associates

Los Angeles, California, 90045

Rogers, Arkansas

Status

Recruiting

Address

Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

Rogers, Arkansas, 72758

Johnson Dermatology Clinic, Fort Smith, Arkansas

Status

Recruiting

Address

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916

Total Skin & Beauty Dermatology Center, Birmingham, Alabama

Status

Recruiting

Address

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35205

International Sites

Toronto, Canada

Status

Recruiting

Address

Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor

Toronto, , M4W 2N2

Skinsense Medical Research, Saskatoon, Saskatchewan, Canada

Status

Recruiting

Address

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 0H6

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 3B8

Dr Isabelle Delorme inc, Drummondville, Quebec, Canada

Status

Recruiting

Address

Dr Isabelle Delorme inc

Drummondville, Quebec, J2B 5L4

Windsor Clinical Research Inc., Windsor, Ontario, Canada

Status

Recruiting

Address

Windsor Clinical Research Inc.

Windsor, Ontario, N8W5L7

K. Papp Clinical Research, Waterloo, Ontario, Canada

Status

Recruiting

Address

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4

Toronto Research Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Toronto Research Centre

Toronto, Ontario, M3H 5Y8

Skin Center for Dermatology, Peterborough, Ontario, Canada

Status

Recruiting

Address

Skin Center for Dermatology

Peterborough, Ontario, K9J 5K2

North Bay Dermatology Centre, North Bay, Ontario, Canada

Status

Recruiting

Address

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7

Lynderm Research, Markham, Ontario, Canada

Status

Recruiting

Address

Lynderm Research

Markham, Ontario, L3P1X2

DermEffects, London, Ontario, Canada

Status

Recruiting

Address

DermEffects

London, Ontario, N6H 5L5

Guelph Dermatology Research, Guelph, Ontario, Canada

Status

Recruiting

Address

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7

Barrie, Ontario, Canada

Status

Recruiting

Address

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1

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

Status

Not yet recruiting

Address

Karma Clinical Trials

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

Brunswick Dermatology Centre, Fredericton, New Brunswick, Canada

Status

Recruiting

Address

Brunswick Dermatology Centre

Fredericton, New Brunswick, E3B 1G9

SkinWise Dermatology, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

SkinWise Dermatology

Winnipeg, Manitoba, R3M3Z4

Winnipeg Clinic Dermatology Research, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3CON2

Enverus Medical Research, Surrey, British Columbia, Canada

Status

Recruiting

Address

Enverus Medical Research

Surrey, British Columbia, V3V 0C6

Chih-Ho Hong Medical, Inc., Surrey, British Columbia, Canada

Status

Recruiting

Address

Chih-Ho Hong Medical, Inc.

Surrey, British Columbia, V3R 6A7

Stratica Medical, Edmonton, Alberta, Canada

Status

Recruiting

Address

Stratica Medical

Edmonton, Alberta, T5K 1X3

Institute for Skin Advancement, Calgary, Alberta, Canada

Status

Recruiting

Address

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Supported by

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