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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03721172

Run by

Amgen

People needed

595

Starts

2019-03-11

Expected to finish

2020-07-24

Last updated by the study team

2024-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
• Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
• Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
• Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
• Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
• Subject must meet laboratory criteria.
• 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.

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• 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.
• Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
• Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
• Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
• 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.
• Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
• Subject had prior treatment with apremilast.

Where it is running

• Johnson Dermatology Clinic — Fort Smith, Arkansas, United States
• Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology — Rogers, Arkansas, United States
• Dermatology Research Associates — Los Angeles, California, United States
• TCR Medical Corporation — San Diego, California, United States
• University of California San Francisco Psoriasis and Skin Treatment Center — San Francisco, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• University of Colorado Hospital - Dermatology Clinic — Aurora, Colorado, United States
• Total Vein and Skin, LLC — Boynton Beach, Florida, United States
• Florida Academic Centers Research and Education — Coral Gables, Florida, United States
• International Dermatology Research — Miami, Florida, United States
• Center for Clinical and Cosmetic Research — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• University of South Florida - Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida, United States
• Atlanta Dermatology, Vein and Research Center, PC — Alpharetta, Georgia, United States
• Medical Dermatology Specialists, Inc. - Advanced Medical Research — Atlanta, Georgia, United States
• MedaPhase INC — Newnan, Georgia, United States
• Gwinnett Clinical Research Center, Inc. — Snellville, Georgia, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Clinical Trials Management LLC — Metairie, Louisiana, United States
• Derm Associates — Rockville, Maryland, United States
• Lawrence Green, MD, LLC — Rockville, Maryland, United States
• ActivMed Practices & Research Inc — Beverly, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Medical Center - New Center One — Detroit, Michigan, United States
• Total Skin & Beauty Dermatology Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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