Psoriasis Clinical Trial
An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
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.
The study will consist of four phases:
Screening Phase - up to 35 days
Double-blind Placebo-controlled Phase - Weeks 0 to 16
- Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.
Apremilast Extension Phase - Weeks 16 to 32
- All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.
Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
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
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.
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There are 52 Locations for this study
Birmingham Alabama, 35233, United States
Fountain Valley California, 92708, United States
Santa Monica California, 90404, United States
Margate Florida, 33073, United States
Miami Florida, 33144, United States
Macon Georgia, 31217, United States
Indianapolis Indiana, 46250, United States
Overland Park Kansas, 66211, United States
Beverly Massachusetts, 01915, United States
Boston Massachusetts, 02115, United States
Henderson Nevada, 89052, United States
Las Vegas Nevada, 89144, United States
Lebanon New Hampshire, 03766, United States
Portsmouth New Hampshire, 03801, United States
Stony Brook New York, 11790, United States
High Point North Carolina, 27262, United States
Athens Ohio, 45701, United States
Gahanna Ohio, 43230, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19103, United States
Johnston Rhode Island, 02919, United States
Houston Texas, 77004, United States
Pflugerville Texas, 78660, United States
Norfolk Virginia, 23502, United States
Bellevue Washington, 98004, United States
Morgantown West Virginia, 26505, United States
Brussels , 1000, Belgium
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
London Ontario, N6A 3, Canada
Markham Ontario, L3P1X, Canada
Waterloo Ontario, N2J 1, Canada
Saint-Jerome Quebec, J7Z 7, Canada
St. John's , A1E 1, Canada
Lille , 59037, France
Nice , 06202, France
Pessac , 33604, France
Toulouse , 31000, France
Berlin , 10789, Germany
Bonn , 53127, Germany
Erlangen , 91054, Germany
Frankfurt am Main , 60590, Germany
Luebeck , 23538, Germany
Mainz , 55101, Germany
Ancona , 60020, Italy
Grosseto , 58100, Italy
LAquila , 67100, Italy
Padova , 35128, Italy
Reggio Calabria , 89124, Italy
Terracina , 04019, Italy
Trieste , 34125, Italy
San Juan , 00917, Puerto Rico
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