Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis (NCT01690299) | Clinical Trial Compass
CompletedPhase 3
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
United States250 participantsStarted 2012-10-01
Plain-language summary
This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males or females, ≥ 18 years of age
* Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior to Screening, and a candidate for phototherapy and/or systemic (including etanercept) therapy
* Had an inadequate response, intolerance, or contraindication to at least 1 conventional systemic agent for the treatment of psoriasis.
* No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis
Exclusion Criteria:
* Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; 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.
* Pregnant or breast feeding.
* Have failed more than 3 systemic agents for treatment of psoriasis.
* History of allergy to any component of the investigational product (IP), including human immunoglobulin (Ig) proteins or allergy to etanercept.
* Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
* Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, Clostridium difficile).
* Have a history of, or ongoing, chronic or recurrent infectious disease
* Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before first administration of IP, or thro…
What they're measuring
1
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline