Psoriasis Clinical Trial
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
Summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Subject must be male or female, ≥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 mild to moderate plaque psoriasis at both Screening and Baseline.
Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
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.
Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Subjects has 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.
2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.
8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
9. Subject had prior treatment with apremilast.
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There are 63 Locations for this study
Birmingham Alabama, 35205, United States
Fort Smith Arkansas, 72916, United States
Rogers Arkansas, 72758, United States
Los Angeles California, 90045, United States
San Diego California, 92123, United States
San Francisco California, 94118, United States
Santa Monica California, 90404, United States
Aurora Colorado, 80045, United States
Boynton Beach Florida, 33437, United States
Coral Gables Florida, 33134, United States
Miami Florida, 33144, United States
Miami Florida, 33180, United States
Ocala Florida, 34470, United States
Tampa Florida, 33612, United States
Alpharetta Georgia, 30022, United States
Atlanta Georgia, 30328, United States
Newnan Georgia, 30263, United States
Snellville Georgia, 30078, United States
Indianapolis Indiana, 46256, United States
Metairie Louisiana, 70006, United States
Rockville Maryland, 20850, United States
Rockville Maryland, 20850, United States
Beverly Massachusetts, 01915, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Fridley Minnesota, 55432, United States
Saint Louis Missouri, 63117, United States
Las Vegas Nevada, 89148, United States
East Windsor New Jersey, 08520, United States
Bronx New York, 10467, United States
New York New York, 10003, United States
Winston-Salem North Carolina, 27104, United States
Columbus Ohio, 43210, United States
Fairborn Ohio, 45324, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15213, United States
Johnston Rhode Island, 02919, United States
Charleston South Carolina, 29407, United States
Pflugerville Texas, 78660, United States
Webster Texas, 77598, United States
Murray Utah, 84107, United States
Norfolk Virginia, 23502, United States
Morgantown West Virginia, 26505, United States
Calgary Alberta, T3A 2, Canada
Edmonton Alberta, T5K 1, Canada
Surrey British Columbia, V3R 6, Canada
Surrey British Columbia, V3V 0, Canada
Winnipeg Manitoba, R3CON, Canada
Winnipeg Manitoba, R3M 3, Canada
Fredericton New Brunswick, E3B 1, Canada
Saint John's Newfoundland and Labrador, A1A 4, Canada
Barrie Ontario, L4M 7, Canada
Guelph Ontario, N1L 0, Canada
London Ontario, N6H 5, Canada
Markham Ontario, L3P 1, Canada
North Bay Ontario, P1B 3, Canada
Peterborough Ontario, K9J 5, Canada
Toronto Ontario, M3H 5, Canada
Toronto Ontario, M4W 2, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 5, Canada
Drummondville Quebec, J2B 5, Canada
Saint-Jerome Quebec, J7Z 7, Canada
Saskatoon Saskatchewan, S7K 0, Canada
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