Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis, Plaque-type Psoriasis

In brief

The purpose of this study was to test if the drug apremilast was safe, if it helped improve psoriasis, and how well the participants tolerated it.

Key facts

Study ID

NCT00773734

Run by

Amgen

People needed

352

Starts

2008-09-01

Expected to finish

2015-05-20

Last updated by the study team

2020-05-07

Who can join

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

You may qualify if…

• Understand and voluntarily sign an informed consent form
• ≥18 years of age at the time of signing the informed consent form
• Able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:
• PASI (Psoriasis Area and Severity Index) score ≥ 12
• Body Surface Area (BSA) ≥ 10%
• Candidate for photo/systemic therapy
• In good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis
• Meet all laboratory criteria as defined per protocol
• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication
• Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication

You may not qualify if…

• History of clinically significant disease (as determined by the investigator)
• Pregnant or breastfeeding
• History of active mycobacterial infection within 3 years
• History of Human Immunodeficiency Virus (HIV) infection
• Congenital and acquired immunodeficiencies
• Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
• Antibodies to Hepatitis C at screening
• Malignancy or history of malignancy except for treated [i.e., cured] basal-cell skin carcinomas
• Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Psoriasis flare within 4 weeks of screening
• Topical therapy within 2 weeks of randomization
• Systemic therapy for psoriasis within 4 weeks of randomization
• Use of phototherapy within 4 weeks of randomization [(i.e., Ultraviolet (UVB), Psoralens and long-wave ultraviolet radiation (PUVA)]
• Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization
• Alefacept within 24 weeks of randomization
• Investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)
• Prolonged sun exposure or use of tanning booths or other ultraviolet light sources

Where it is running

• Associates In Research Inc — Fresno, California, United States
• Dermatology Associates — Los Angeles, California, United States
• Stanford University School of Medicine — Redwood City, California, United States
• Atlantic Skin & Cosmetic Surgery Group, PC — Wilmington, Delaware, United States
• Renstar Medical Research — Ocala, Florida, United States
• Atlanta Dermatology, Vein & Research Center — Alpharetta, Georgia, United States
• NorthShore University HealthSystem — Skokie, Illinois, United States
• Dawes/Fretzin Dermatology Group Inc — Indianapolis, Indiana, United States
• Dermatology & Advanced Aesthetics — Lake Charles, Louisiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Central Dermatology — St Louis, Missouri, United States
• UMDNJ Robert Wood Johnson — New Brunswick, New Jersey, United States
• Wright State University — Dayton, Ohio, United States
• Allergy, Asthma and Dermatology Research Center — Lake Oswego, Oregon, United States
• Northwest Cutaneous Research Specialists — Portland, Oregon, United States
• Oregon Med. Research Center, PC — Portland, Oregon, United States
• Rivergate Dermatology Clinical Research — Goodlettsville, Tennessee, United States
• Modern Research Associates — Dallas, Texas, United States
• Dermatology Associates of Seattle — Seattle, Washington, United States
• Aurora Advanced Healthcare, Inc — Milwaukee, Wisconsin, United States
• Stratica Medical — Edmonton, Alberta, Canada
• Dr. Lorne E. Albrecht — Surrey, British Columbia, Canada
• Alpha Clinical Research Centre — St. John's, Newfoundland and Labrador, Canada
• Eastern Canada Cutaneous Research Associates — Halifax, Nova Scotia, Canada
• Ultranova Skincare — Barrie, Ontario, Canada

Full record on ClinicalTrials.gov

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