A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

Completed · Phase 4 · Has a placebo group

Conditions studied: Parapsoriasis

In brief

This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Key facts

Study ID

NCT02425826

Run by

Amgen

People needed

221

Starts

2015-04-20

Expected to finish

2016-11-22

Last updated by the study team

2023-06-05

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.
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
• Able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the informed consent.
• Have moderate plaque psoriasis at screening and baseline as defined by
• BSA (Body Surface Area)5% to 10% and
• sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale
• Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories.
• No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis.
• Females of childbearing potential (FCBP)must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product

You may not qualify if…

• Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled.
• 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.
• Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis.
• Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
• Pregnant or breast feeding.
• Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent.
• Malignancy or history of malignancy, except for:
• treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
• treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
• Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization.
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
• Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study.
• Prior treatment with apremilast.

Where it is running

• UAB at Birmingham - The Kirklin Clinic — Birmingham, Alabama, United States
• Center For Dermatology — Fremont, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Blue Harbor Dermatology — Newport Beach, California, United States
• Center for Dermatology and Laser Surgery — Sacramento, California, United States
• East Bay Rheumatology Medical — San Leandro, California, United States
• Tien Q. Nguyen MD Inc — Tustin, California, United States
• UConn Health Center — Farmington, Connecticut, United States
• Dermatology Associates — Panama City, Florida, United States
• USF Health Faculty Office Building-FOB — Tampa, Florida, United States
• Forward Clinical Trials Inc — Tampa, Florida, United States
• Dermatologic Surgery Specialists, P.C. — Macon, Georgia, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• Dermatology Specialists, PSC — Louisville, Kentucky, United States
• DermResearch, PLLC — Louisville, Kentucky, United States
• Lawrence Green, MD, LLC — Rockville, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Las Vegas Skin and Cancer Clinics — Las Vegas, Nevada, United States
• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
• Garden City Dermatology — Garden City, New York, United States
• Sadick Research Group — New York, New York, United States
• Dermatology Associates of Rochester PC — Rochester, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Dermatology and Laser Center of Charleston — Charleston, South Carolina, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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