Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 17, 2008
October 9, 2012
January 2005
October 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00604682 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis
Open-Label, Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC10004 in Subjects With Severe Plaque Type Psoriasis

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
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
Not Provided
Gottlieb AB, Strober B, Krueger JG, Rohane P, Zeldis JB, Hu CC, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin. 2008 May;24(5):1529-38. Epub 2008 Apr 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00604682
CC-10004-PSOR-001
No
Patricia Rohane, MD, Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Patricia Rohane, MD Celgene Corporation
Celgene Corporation
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP