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Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
This study is currently recruiting participants.
Verified by Celgene Corporation, October 2008
Sponsored by: Celgene Corporation
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00773734
  Purpose

The purpose of this study is to test if the study drug apremilast is safe, if it helps improve psoriasis, and how subjects tolerate it.


Condition Intervention Phase
Psoriasis
Plaque-Type Psoriasis
Drug: Apremilast 10mg
Drug: Apremilast 20mg
Drug: Apremilast 30mg
Drug: Placebo
Phase II

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Proportion of subjects treated with oral apremilast who achieve a Psoriasis Area and Severity Index (PASI)-75 at Week 16 in reference to baseline [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Type, frequency, severity and relationship of adverse events to apremilast [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of 3 oral doses of apremilast in subjects with moderate-to-severe plaque-type psoriasis [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effects of 3 oral doses of apremilast on the quality of life in subjects with moderate-to-severe plaque-type psoriasis. [ Time Frame: Baseline, Weeks 16 and 24 ] [ Designated as safety issue: No ]
  • To determine a dose-response relationship in 3 oral doses of apremilast using percent reduction of PASI scores in subjects with moderate-to-severe plaque-type psoriasis [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetics (PK) of apremilast in subjects with moderate-to-severe plaque-type psoriasis. [ Time Frame: Approximately every 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: September 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Apremilast 10mg: Active Comparator Drug: Apremilast 10mg
10mg tablets
Apremilast 20mg: Active Comparator Drug: Apremilast 20mg
20mg tablets
Apremilast 30mg: Active Comparator Drug: Apremilast 30mg
30mg tablets
Placebo: Placebo Comparator Drug: Placebo
Apremilast identically appearing placebo tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form
  • ≥18 years of age at the time of signing the informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:

    1. PASI score ≥ 12
    2. BSA ≥ 10%
  • Candidate for photo/systemic therapy
  • In good health as judged by the investigator, based on medical history, physical examination, 12-lead ECG, serum chemistry, hematology, immunology, and urinalysis
  • Meet all laboratory criteria as defined per
  • Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication
  • Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication

Exclusion Criteria:

  • History of clinically significant disease(as determined by the investigator)
  • Pregnant or breastfeeding
  • History of active mycobacterial infection within 3 years
  • History of Human Immunodeficiency Virus (HIV) infection
  • Congenital and acquired immunodeficiencies
  • Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
  • Antibodies to Hepatitis C at screening
  • Malignancy or history of malignancy except for treated [i.e., cured] basal-cell skin carcinomas
  • Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Psoriasis flare within 4 weeks of screening
  • Topical therapy within 2 weeks of randomization
  • Systemic therapy for psoriasis within 4 weeks of randomization
  • Use of phototherapy within 4 weeks of randomization (i.e., UVB, PUVA)
  • Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization
  • Alefacept within 24 weeks of randomization
  • Investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)
  • Prolonged sun exposure or use of tanning booths or other ultraviolet light sources
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773734

Contacts
Contact: Dale McElveen 908-860-7493 dmcelveen@celgene.com
Contact: Vilma Hernandez 908-860-7559 vhernandez@celgene.com

Locations
United States, California
Associates In Research Inc Recruiting
Fresno, California, United States, 93720
Contact: Pang Vang     559-432-6457     pang@assoc-in-research.com    
Principal Investigator: Regina Hamlin, MD            
United States, Delaware
Atlantic Skin & Cosmetic Surgery Group, PC Recruiting
Wilmington, Delaware, United States, 19810
Contact: Shannon Denney     302-478-8532     shanld293@aol.com    
Principal Investigator: Michael Saruk, MD            
United States, Florida
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34471
Contact: Mary Standey     352-629-5800 ext 131     mary.standley@renstar.net    
Principal Investigator: Frederick Behringer, MD            
United States, Georgia
Atlanta Dermatology, Vein & Research Center Recruiting
Alpharetta, Georgia, United States, 30022
Contact: Erika Heidl     770-360-8881     erika@dermandvein.com    
Principal Investigator: Tiffani K Hamilton, MD            
United States, Indiana
Dawes/Fretzin Dermatology Group Inc Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Katy Byrd     317-621-7790 ext 123     kbyrd@ecommunity.com    
Principal Investigator: Scott A Fretzin, MD            
United States, Louisiana
Dermatology & Advanced Aesthetics Recruiting
Lake Charles, Louisiana, United States, 70605
Contact: Cindi Reed     337-477-0011     creed@shondrasmithmd.com    
Principal Investigator: Shondra Smith, MD            
United States, Minnesota
Minnesota Clinical Study Center Recruiting
Fridley, Minnesota, United States, 55432
Contact: Dawn Snow     763-571-4200 ext 221        
Principal Investigator: Steven E. Kempers, MD            
United States, Oregon
Northwest Cutaneous Research Specialists Recruiting
Portland, Oregon, United States, 97210
Contact: Teri Paris     503-226-3376 ext 15     teriparis@verizon.net    
Principal Investigator: Phoebe Rich, MD            
United States, Tennessee
Rivergate Dermatology Clinical Research Recruiting
Goodlettsville, Tennessee, United States, 37072
Contact: Janet Reed     615-859-7546     jreed@rivderm.com    
Principal Investigator: Keith H Loven, MD            
United States, Wisconsin
Aurora Advanced Healthcare, Inc Recruiting
Milwaukee, Wisconsin, United States, 53209
Contact: Carrie Ceman     414-352-5161 ext 4690        
Principal Investigator: Eugene Monroe, MD            
Sponsors and Collaborators
Celgene Corporation
  More Information

Responsible Party: Celgene Corporation ( Yong Lin, MD )
Study ID Numbers: CC-10004-PSOR-005
Study First Received: October 14, 2008
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00773734  
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
moderate-to-severe plaque-type psoriasis

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 14, 2009