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

NCT00678210 | Completed Phase 2 Results

• 1 other identifier: A3921047
• Study Type: interventional
• Target: 197
• Locations: 2 countries
• Sites: 44

Brief Summary

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.

Conditions

Psoriasis

Keywords

dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"

  Week 2, 4, 8, 12, 14, 16

• Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score

  Week 2, 4, 8, 14, 16

• Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score

  Week 2, 4, 8, 12, 14, 16

• Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score

  Week 12

• Psoriasis Area and Severity Index (PASI) Component Scores and Total Score

  Baseline, Week 2, 4, 8, 12, 14, 16

Study Arms (4)

1

EXPERIMENTAL

Drug: CP-690,550

2

EXPERIMENTAL

Drug: CP-690,550

3

EXPERIMENTAL

Drug: CP-690,550

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CP-690,550 DRUG

tablets, 2 mg BID for 12 weeks

1

Placebo DRUG

tablets, BID for 12 weeks

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (44)

Pfizer Investigational Site

Tucson, Arizona, 85710, United States

Location

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Little Rock, Arkansas, 72205, United States

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Oceanside, California, 92056, United States

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Jacksonville, Florida, 32204, United States

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Miami, Florida, 33144, United States

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West Dundee, Illinois, 60118, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Worcester, Massachusetts, 01610, United States

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St Louis, Missouri, 63117, United States

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East Windsor, New Jersey, 08520, United States

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Paramus, New Jersey, 07652, United States

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New York, New York, 10016, United States

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Rochester, New York, 14623, United States

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Winston-Salem, North Carolina, 27103, United States

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Cleveland, Ohio, 44106, United States

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Norman, Oklahoma, 73069, United States

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Lake Oswego, Oregon, 97035, United States

Location

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97223, United States

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Philadelphia, Pennsylvania, 19104, United States

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Greer, South Carolina, 29650, United States

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Greer, South Carolina, 29651, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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Webster, Texas, 77598, United States

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Salt Lake City, Utah, 84132, United States

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Norfolk, Virginia, 23507, United States

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Vancouver, British Columbia, V5Z 4E8, Canada

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Moncton, New Brunswick, E1C 8X3, Canada

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St. John's, Newfoundland and Labrador, A1C 2H5, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3H 1Y6, Canada

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Halifax, Nova Scotia, B3H 1Z4, Canada

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Barrie, Ontario, L4M 6L2, Canada

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London, Ontario, N5X 2P1, Canada

Location

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North Bay, Ontario, P1B 3Z7, Canada

Location

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Waterloo, Ontario, N2J 1C4, Canada

Location

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Windsor, Ontario, N8W 5L7, Canada

Location

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Laval, Quebec, H7S 2C6, Canada

Location

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Montreal, Quebec, H2K 4L5, Canada

Location

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Montreal, Quebec, H3Z 2S6, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 4X7, Canada

Location

Related Publications (6)

• 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.

  PMID: 32816215 DERIVED

• 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.

  PMID: 25951857 DERIVED

• 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.

  PMID: 24595567 DERIVED

• 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.

  PMID: 24289224 DERIVED

• 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.

  PMID: 23855761 DERIVED

• 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.

  PMID: 22924949 DERIVED

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: May 15, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 19, 2012
• Results First Posted: December 19, 2012

Record last verified: 2012-11

Locations

US (29); CA (15)