Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis, Psoriatic Arthritis

In brief

This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.

Key facts

Study ID

NCT01690299

Run by

Amgen

People needed

250

Starts

2012-10-01

Expected to finish

2016-04-04

Last updated by the study team

2022-03-15

Who can join

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

You may qualify if…

• Males or females, ≥ 18 years of age
• Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior to Screening, and a candidate for phototherapy and/or systemic (including etanercept) therapy
• Had an inadequate response, intolerance, or contraindication to at least 1 conventional systemic agent for the treatment of psoriasis.
• No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis

You may not qualify if…

• Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; 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.
• Pregnant or breast feeding.
• Have failed more than 3 systemic agents for treatment of psoriasis.
• History of allergy to any component of the investigational product (IP), including human immunoglobulin (Ig) proteins or allergy to etanercept.
• Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
• Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, Clostridium difficile).
• Have a history of, or ongoing, chronic or recurrent infectious disease
• Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before first administration of IP, or through Week 20 during the study.
• Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
• History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
• Active substance abuse or a history of substance abuse within 6 months prior to Screening.
• Malignancy or history of malignancy, except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.
• Psoriasis flare or rebound within 4 weeks prior to Screening.
• Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis within 4 weeks prior to randomization
• Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
• Any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
• Prior treatment with apremilast or etanercept.

Where it is running

• Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield, California, United States
• University of California Irvine-Department of Dermatology — Irvine, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• Horizons Clinical Research — Denver, Colorado, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Florida Center for Dermatology, PA — Jacksonville, Florida, United States
• Florida Academic Dermatology Center — Miami, Florida, United States
• International Dermatology Research — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Atlanta Dermatology, Vein and Research Center, PC — Alpharetta, Georgia, United States
• NorthShore University HealthSystem — Skokie, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dermatology and Advanced Aesthetics — Lake Charles, Louisiana, United States
• Lawrence Green, MD, LLC — Rockville, Maryland, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Robert Wood Johnson Medical School — Somerset, New Jersey, United States
• Forest Hills Dermatology Group — Forest Hills, New York, United States
• NYU Department of Dermatology — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Arizona Research Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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