Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis (PSOR-001)

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00604682
First received: January 17, 2008
Last updated: October 9, 2012
Last verified: January 2008
  Purpose

Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis.


Condition Intervention Phase
Psoriasis
Drug: CC10004
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC10004 in Subjects With Severe Plaque Type Psoriasis

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis. [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of orally administered CC10004 in subjects with severe plaque-type psoriasis during the treatment and follow up phases. [ Time Frame: 58 days ] [ Designated as safety issue: No ]
  • To explore the clinical efficacy of orally administered CC10004 when taken for 29 days in subjects with severe plaque-type psoriasis. [ Time Frame: 29 days ] [ Designated as safety issue: No ]
  • To explore the clinical efficacy of CC10004 when taken for 29 days in subjects with psoriatic arthritis. [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2005
Study Completion Date: December 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CC10004
    2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted
    Other Name: Apremilast
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Must understand and voluntarily sign an informed consent form
  • Must be age > or = to 18 years to 65 years at the time of singing the informed consent form.
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must have a history of severe plaque type psoriasis for at least 6 months, and at least a 15% affected total body surface area (BSA)
  • Must meet the following clinical laboratory criteria:
  • White Blood Cell Count > or = to 3000/cu mm and < 20,000/cu mm
  • Platelet count > or = to 100,000/microliters
  • Serum creatinine < or = to 1.5 mg/dl
  • Total bilirubin < or = to 2.0 mg/dl
  • AST (SGOT) and ALT (SGPT) < or = to 1.5 X ULN
  • Must have a psoriatic plaque > or = to 2.5 cm in diameter (for biopsy)
  • Must be candidate for photo/systemic therapy (a subject is considered a candidate for photo/systemic therapy if a clinician judges that the subject requires any systemic therapy (e.g., ultraviolet light B(UVB), Psoralens and long-wave ultraviolet radiation (PUVA), cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine)to control psoriasis whether or not that subject has a history of receiving systemic therapy)
  • Women of child bearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use two forms of adequate forms on contraception throughout the trial.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality , or psychiatric illness that would prevent the subject from signing the informed consent form
  • Pregnant or lactating females
  • Any condition, including the presence of laboratory abnormalities, which 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
  • Current erythrodermic, guttate, or pustular psoriasis
  • Use of medication that is metabolized by the CYP3A4 or CYP2A6 pathways within the 14 days of study medication initiation and/or required use of such medication during study treatment.
  • Drinking or ingesting grapefruits, grapefruit juice or grapefruit containing products within 14 days of study medication initiation
  • Use of topical therapy ( topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of study medications initiation (Exception: Non-medicated emollients and tar shampoo will be allowed)
  • Use of systemic therapy for psoriasis
  • Use or phototherapy within 28 days of study medication initiation
  • Use Humira or Remicade within 3 months of study medication initiation
  • Use of Enbrel within 56 days of study medication initiation
  • Use of Raptiva within 56 days of study medication initiation
  • Use of Amevive within 6 months of study medication initiation
  • Use of any investigational drug within 30 days of study medication initiation or 5 half lives if known
  • History of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease or other major diseases
  • Clinically significant abnormality on 12-lead ECG at screening
  • Positive HIV, Hepatitis B or Hepatitis C laboratory result at screening
  • History of active tuberculosis within previous 3 years
  • Clinically significant abnormality on the chest x-ray at screening or on CXR taken within 6 months of screening
  • History of positive purified protein derivative (PPD) test at screening
  • History of malignancy within previous five years
  • Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604682

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Mt Sinai School of Medicine
New York, New York, United States, 10029
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Patricia Rohane, MD Celgene Corporation
  More Information

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia Rohane, MD, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00604682     History of Changes
Other Study ID Numbers: CC-10004-PSOR-001
Study First Received: January 17, 2008
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on October 16, 2014