An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe). Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Key facts

Study ID: NCT03777436
Run by: Amgen
People needed: 289
Starts: 2019-02-11
Expected to finish: 2022-02-09
Last updated by the study team: 2024-05-14

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 is ≥ 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 moderate or severe psoriasis of the genital area at Screening and Baseline.
Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline.
Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening and Baseline.
Subject must have been inadequately controlled with or intolerant of topical therapy, or topical therapy is inappropriate for the treatment of psoriasis affecting the genital area.
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

You may not qualify if…

The presence of any of the following will exclude a subject from enrollment:
Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study.
Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening.
Subject has active tuberculosis (TB) or a history of incompletely treated TB.
Subject has 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.
Subject has current or planned therapies that may have a possible effect on psoriasis of the body and/or genital area during the course of the treatment phase of the trial
Subject had prior treatment with apremilast.

Where it is running

First OC Dermatology — Fountain Valley, California, United States
Clinical Science Institute — Santa Monica, California, United States
Glick Skin Institute — Margate, Florida, United States
International Dermatology Research, Inc — Miami, Florida, United States
Skin Care Physicians of Georgia — Macon, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
Adult and Pediatric Dermatology — Overland Park, Kansas, United States
ActivMed Practices and Research Inc — Beverly, Massachusetts, United States
Brigham and Womens Hospital — Boston, Massachusetts, United States
J Woodson Dermatology and Associates — Henderson, Nevada, United States
Las Vegas Dermatology — Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
ActivMed — Portsmouth, New Hampshire, United States
Stony Brook Dermatology Associates — Stony Brook, New York, United States
Dermatology Consulting Services — High Point, North Carolina, United States
Oakview Dermatology — Athens, Ohio, United States
Ohio State University Medical Center — Gahanna, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
Paddington Testing Company Inc — Philadelphia, Pennsylvania, United States
Clinical Partners LLC — Johnston, Rhode Island, United States
Center for Clinical Studies — Houston, Texas, United States
Austin Institute for Clinical Research — Pflugerville, Texas, United States
Virginia Clinical Research Inc — Norfolk, Virginia, United States
Bellevue Dermatology Clinic — Bellevue, Washington, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.