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A Phase 3b, Multicenter, Randomized, Placebo-Controlled, Double Blind, Double-Dummy, Study of the Efficacy and Safety of Apremilast (CC-10004), Etanercept, and Placebo, in Subjects With Moderate to Severe Plaque Psoriasis

Phase 3
18 Years
Open (Enrolling)
Psoriasis, Psoriatic Arthritis

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Trial Information

A Phase 3b, Multicenter, Randomized, Placebo-Controlled, Double Blind, Double-Dummy, Study of the Efficacy and Safety of Apremilast (CC-10004), Etanercept, and Placebo, in Subjects With Moderate to Severe Plaque Psoriasis

This is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy,
study of the efficacy and safety of apremilast, etanercept, and placebo, in subjects with
moderate to severe plaque psoriasis.

Approximately 240 subjects will be randomized 1:1:1 to the three treatment groups. All
subjects will receive both tablets and injections through Week 16.

The study will consist of four phases:

- Screening Phase - up to 35 days

- Double-blind Placebo-controlled Phase - Weeks 0-16

- Apremilast Extension Phase - Weeks 16-104

- Post-treatment Observational Follow-up Phase

During the double-blind, placebo-controlled phase, subjects will receive treatment with one
of the following:

- apremilast (APR) 30 mg tablets orally twice a day (BID) plus once weekly (QW)
evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections (1 mL x 2
injections SC), or

- etanercept (ETN) 50 mg evaluator/subject-blinded subcutaneous (SC) once weekly (QW)
injections (2 x 25 mg) plus placebo tablets orally twice a day (BID), or

- placebo tablets and evaluator/subject-blinded subcutaneous (SC) saline (placebo)

All subjects will be asked to participate in a 4-week Post-treatment Observational Follow-up
Phase either upon completion of the study or upon discontinuation of investigational product
for those subjects who terminate the study early.

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

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Apremilast Psoriasis Area and Severity Index-75 (PASI)

Outcome Description:

Proportion of subjects with either apremilast 30 mg twice a day (BID) or placebo who achieve at least a 75% reduction in PASI (PASI-75) at Week 16 from baseline

Outcome Time Frame:

Week 16

Safety Issue:


Principal Investigator

Lilia Pineda, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

August 2015

Related Keywords:

  • Psoriasis
  • Psoriatic Arthritis
  • Psoriasis
  • arthritis
  • psoriatic
  • psoriasis
  • palmoplantar
  • scalp
  • Arthritis
  • Arthritis, Psoriatic
  • Psoriasis



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Renstar Medical Research Ocala, Florida  34474
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
University of California, San Diego La Jolla, California  92037-1709
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Tennessee Clinical Research Center Nashville, Tennessee  37221
Virginia Clinical Research, Inc Norfolk, Virginia  23507
Dawes Fretzin Clinical Research Group, LLC Indianapolis, Indiana  46256
Arizona Research Center Phoenix, Arizona  85023
Dermatology Associates Seattle, Washington  98101
University Hospitals Case Medical Center Cleveland, Ohio  44106
Florida Academic Dermatology Center Miami, Florida  33136
Dermatology & Advanced Aesthetics Lake Charles, Louisiana  70605
UMDNJ Robert Wood Johnson, Medical School Division New Brunswick, New Jersey  08901
Lawrence Green, MD, LLC Rockville, Maryland  20850
Bakersfield Dermatology and Skin Cancer Medical Group Bakersfield, California  93309
Horizons Clinical Research Denver, Colorado  80220
International Dermatology Research Inc Miami, Florida  33144
Florida Center for Dermatology, PA St. Augustine, Florida  32086
Southern Illinois University School of Medicine Dermatology/Internal Medicine Springfield, Illinois  62702
Robert Wood Johnson Medical School/UMDNJ Department of Dermatology Somerset, New Jersey  08873
Forest Hills Dermatology Group Forest Hills, New York  11375
NYU Department of Dermatology New York, New York  100616-6402
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