Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.

Completed · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Key facts

Study ID

NCT01232283

Run by

Amgen

People needed

413

Starts

2010-11-22

Expected to finish

2016-11-30

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 at the time of signing the informed consent document
• Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
• a. Have moderate to severe plaque psoriasis at Screening and Baseline
• Must meet all laboratory criteria
• Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
• Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.

You may not qualify if…

• Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
• Pregnant or breast feeding
• History of allergy to any component of the study drug
• Hepatitis B surface antigen positive at Screening
• Anti-hepatitis C antibody positive at Screening
• Active tuberculosis (TB) or a history of incompletely treated TB
• Clinically significant abnormality on 12-Lead ECG at Screening
• Clinically significant abnormal chest x-ray
• History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
• Active substance abuse or a history of substance abuse within 6 months prior to Screening
• Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
• Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] 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
• Evidence of skin conditions that would interfere with clinical assessments
• Topical therapy within 2 weeks of randomization
• Systemic therapy for psoriasis within 4 weeks prior to randomization
• Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
• Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
• Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
• Use of any investigational drug within 4 weeks prior to randomization
• Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
• Prior treatment with apremilast

Where it is running

• Arizona Skin and Laser Therapy Inst., Ltd. — Phoenix, Arizona, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Bakersfield Dermatology and Skin Cancer Medical Group — Bakersfield, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Florida Academic Dermatology Center — Miami, Florida, United States
• Advanced Medical Research — Atlanta, Georgia, United States
• MedaPhase Inc. — Newnan, Georgia, United States
• Northwestern University Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Clinical Partners, LLC — Johnston, Rhode Island, United States
• Radiant Research, Inc. — Anderson, South Carolina, United States
• Austin Dermatology Associates — Austin, Texas, United States
• Modern Research Associates PLLC — Dallas, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• Virginia Medical Research — Norfolk, Virginia, United States
• Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie — Vienna, Austria
• Northwest Dermatology and Laser Centre — Calgary, Alberta, Canada
• Stratica Medical — Edmonton, Alberta, Canada
• NewLab Clinical Research — St. John's, Newfoundland and Labrador, Canada
• Skin Center for Dermatology — Peterborough, Ontario, Canada
• Windsor Clinical Research Inc. — Winsor, Ontario, Canada

Full record on ClinicalTrials.gov

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