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Phase 2, Open-label Study to Evaluate CC-10004 Recalcitrant (Not Responded to Therapy) Plaque-type Psoriasis
This study has been completed.
First Received: August 24, 2007   Last Updated: September 28, 2009   History of Changes
Sponsor: Celgene Corporation
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00521339
  Purpose

Phase 2, Open-Label, Multicenter Study to Evaluate CC-10004 in subjects with Recalcitrant (Psoriasis that has Not Responded to Therapy) Plaque-Type Psoriasis


Condition Intervention Phase
Psoriasis
Drug: CC-10004
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Open-label Multi-center Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of CC-10004 in Subjects With Recalcitrant Plaque-type Psoriasis

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of CC-10004, twice per day (BID) for 84 days in subjects with recalcitrant plaque-type psoriasis. [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacodynamic(PD)effects of CC-10004 in plaque-type; characterize PK effects and evaluate clinical efficacy;and determine the effect on quality of life; [ Time Frame: 84 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
open-label: Experimental Drug: CC-10004

20 mg PO. twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension phase.

30 mg BID for subjects meeting the dose escalation protocol criteria can continue the optional treatment extension phase for an additional 84 days, starting on Day 86


  Eligibility

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

Inclusion Criteria:

Must understand and voluntarily sign an informed consent form

  • Must be male or female subject of any ethnic origin or race that is >18 years at time of consent
  • Must have a documented history of plaque-type psoriasis for at least 6 months prior to screening visit
  • Subjects must fulfill criteria outlined in at least one of the following clinical categories:

    • Unresponsive to standard systemic therapy, as defined by clinical history, in the investigator's opinion, i.e. inadequate response to one or more adequate treatment course (s) of standard systemic therapy
    • Intolerant to or cannot receive (e.g., contraindication to prescribe) standard systemic therapy or biological interventions for psoriasis
  • Must have a sPGA score of at least 3 and a BSA ≥ 10% at screening
  • Must meet the specified laboratory criteria:

Must be able to adhere to the study visit schedule and study protocol requirements

  • Females of childbearing potential (FCBP)[1] must have a negative urine pregnancy test at screening (Visit 1). In addition, FCBP must agree to use two of the following adequate forms of contraception methods such as oral, injectable, or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide or vasectomized partner while on study. 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 sexual activity with FCBP

Exclusion Criteria:

History of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease

  • 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
  • Pregnant or lactating females
  • History of active tuberculosis (TB)infection within 3 years prior to the screening visit. Infections which occurred > 3 years prior to entry must have been effectively treated
  • History of incompletely treated latent (as indicated by a positive PPD [purified protein derivative] skin results) TB infection
  • Clinically significant abnormality on the chest x-ray (CXR) at screening
  • Psoriasis flare within 30 days of screening, as defined by protocol
  • Use of systemic therapy for psoriasis within 28 days of Visit 2 (Baseline).
  • Topical therapy as defined in the protocol Adalimumab, etanercept, efalizumab or infliximab use within 56 days of Visit 2 (Baseline)
  • Alefacept use within 180 days of Visit 2 (Baseline)
  • Phototherapy (UVA, NB-UVB, PUVA) within 28 days of Visit 2 (Baseline)
  • Use of any investigational drug within 28 days of Visit 2 (Baseline), or 5 half lives if known (whichever is longer)Clinically significant abnormality on 12-lead ECG at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521339

Locations
United States, Massachusetts
Tufts-New England Medical Center Hospitals
Boston, Massachusetts, United States, 02111
United States, Missouri
Central Dermatology
St. Louis, Missouri, United States, 63117
United States, Oregon
Oregon Medical Research Center, P.C.
Portland, Oregon, United States, 97223
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246-1613
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Robert Day, PhD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation ( Elliot Rosenstein, MD )
Study ID Numbers: CC-10004-PSOR-004
Study First Received: August 24, 2007
Last Updated: September 28, 2009
ClinicalTrials.gov Identifier: NCT00521339     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
psoriasis
psoriatic arthritis
recalcitrant psoriasis
refractory psoriasis

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

ClinicalTrials.gov processed this record on November 30, 2009