Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00678210
First received: May 13, 2008
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).


Secondary Outcome Measures:
  • Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" [ Time Frame: Week 2, 4, 8, 12, 14, 16 ] [ Designated as safety issue: No ]
    Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

  • Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score [ Time Frame: Week 2, 4, 8, 14, 16 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  • Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score [ Time Frame: Week 2, 4, 8, 12, 14, 16 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  • Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  • Psoriasis Area and Severity Index (PASI) Component Scores and Total Score [ Time Frame: Baseline, Week 2, 4, 8, 12, 14, 16 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16 [ Time Frame: Baseline, Week 2, 4, 8, 12, 14, 16 ] [ Designated as safety issue: No ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).


Enrollment: 197
Study Start Date: July 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CP-690,550
tablets, 2 mg BID for 12 weeks
Experimental: 2 Drug: CP-690,550
tablets, 5 mg BID for 12 weeks
Experimental: 3 Drug: CP-690,550
tablets, 15 mg BID for 12 weeks
Placebo Comparator: 4 Drug: Placebo
tablets, BID for 12 weeks

  Eligibility

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

Inclusion Criteria:

  • Have been diagnosed with plaque psoriasis for at least 6 months.
  • Have plaque psoriasis covering at least 15% of their total body.
  • Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
  • Be willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
  • Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
  • Subject is participating in another trial using an investigational agent or procedure.
  • Women who are pregnant or breast-feeding or considering becoming pregnant.
  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: NCT00678210

  Show 44 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00678210     History of Changes
Other Study ID Numbers: A3921047
Study First Received: May 13, 2008
Results First Received: November 19, 2012
Last Updated: November 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014