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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: CP-690,550; Drug: CP-690,550; Drug: CP-690,550; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4X7
    • Pfizer Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Pfizer Investigational Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • Pfizer Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Pfizer Investigational Site
    • Halifax, Nova Scotia, Canada, B3H 1Y6
      • Pfizer Investigational Site
    • Halifax, Nova Scotia, Canada, B3H 1Z4
      • Pfizer Investigational Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Pfizer Investigational Site
    • London, Ontario, Canada, N5X 2P1
      • Pfizer Investigational Site
    • North Bay, Ontario, Canada, P1B 3Z7
      • Pfizer Investigational Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Pfizer Investigational Site
    • Windsor, Ontario, Canada, N8W 5L7
      • Pfizer Investigational Site
  • Quebec
    • Laval, Quebec, Canada, H7S 2C6
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H2K 4L5
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3Z 2S6
      • Pfizer Investigational Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Pfizer Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Pfizer Investigational Site
  • California
    • Oceanside, California, United States, 92056
      • Pfizer Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33144
      • Pfizer Investigational Site
  • Illinois
    • West Dundee, Illinois, United States, 60118
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Pfizer Investigational Site
    • Boston, Massachusetts, United States, 02111
      • Pfizer Investigational Site
    • Worcester, Massachusetts, United States, 01610
      • Pfizer Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Pfizer Investigational Site
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Pfizer Investigational Site
    • Paramus, New Jersey, United States, 07652
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10016
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14623
      • Pfizer Investigational Site
  • North Carolina
    • Winston Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Pfizer Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Pfizer Investigational Site
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97223
      • Pfizer Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Pfizer Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Pfizer Investigational Site
    • Greer, South Carolina, United States, 29650
      • Pfizer Investigational Site
    • Mt. Pleasant, South Carolina, United States, 29464
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77030
      • Pfizer Investigational Site
    • Webster, Texas, United States, 77598
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Pfizer Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: CP-690,550; tablets, 2 mg BID for 12 weeks; Drug: CP-690,550; tablets, 5 mg BID for 12 weeks; Drug: CP-690,550; tablets, 15 mg BID for 12 weeks
Experimental: 2	Drug: CP-690,550; tablets, 2 mg BID for 12 weeks; Drug: CP-690,550; tablets, 5 mg BID for 12 weeks; Drug: CP-690,550; tablets, 15 mg BID for 12 weeks
Experimental: 3	Drug: CP-690,550; tablets, 2 mg BID for 12 weeks; Drug: CP-690,550; tablets, 5 mg BID for 12 weeks; Drug: CP-690,550; tablets, 15 mg BID for 12 weeks
Placebo Comparator: 4	Drug: Placebo; tablets, BID for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12	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).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"	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.	Week 2, 4, 8, 12, 14, 16
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score	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).	Week 2, 4, 8, 14, 16
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score	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).	Week 2, 4, 8, 12, 14, 16
Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score	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).	Week 12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score	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).	Baseline, Week 2, 4, 8, 12, 14, 16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16	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).	Baseline, Week 2, 4, 8, 12, 14, 16

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
• Valenzuela F, Papp KA, Pariser D, Tyring SK, Wolk R, Buonanno M, Wang J, Tan H, Valdez H. Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis. BMC Dermatol. 2015 May 8;15:8. doi: 10.1186/s12895-015-0025-y.
• Menter A, Papp KA, Tan H, Tyring S, Wolk R, Buonanno M. Efficacy of tofacitinib, an oral janus kinase inhibitor, on clinical signs of moderate-to-severe plaque psoriasis in different body regions. J Drugs Dermatol. 2014 Mar;13(3):252-6.
• Bushmakin AG, Mamolo C, Cappelleri JC, Stewart M. The relationship between pruritus and the clinical signs of psoriasis in patients receiving tofacitinib. J Dermatolog Treat. 2015 Feb;26(1):19-22. doi: 10.3109/09546634.2013.861891. Epub 2013 Dec 2.
• Strober B, Buonanno M, Clark JD, Kawabata T, Tan H, Wolk R, Valdez H, Langley RG, Harness J, Menter A, Papp K. Effect of tofacitinib, a Janus kinase inhibitor, on haematological parameters during 12 weeks of psoriasis treatment. Br J Dermatol. 2013 Nov;169(5):992-9. doi: 10.1111/bjd.12517.
• Papp KA, Menter A, Strober B, Langley RG, Buonanno M, Wolk R, Gupta P, Krishnaswami S, Tan H, Harness JA. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study. Br J Dermatol. 2012 Sep;167(3):668-77. doi: 10.1111/j.1365-2133.2012.11168.x.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: May 13, 2008
• First Submitted That Met QC Criteria: May 13, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 19, 2012
• Last Update Submitted That Met QC Criteria: November 19, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921047