Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

• Status: Completed
• Trial end date: 2016-04-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Celgene Corporation
• Treatments: Apremilast; Etanercept; Thalidomide

Criteria

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 through Week 20 during the study.

• Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.

• History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).

• Active substance abuse or a history of substance abuse within 6 months prior to Screening.

• Malignancy or history of malignancy, except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.

• Psoriasis flare or rebound within 4 weeks prior to Screening.

• Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis within 4 weeks prior to randomization

• Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.

• Any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

• Prior treatment with apremilast or etanercept.