A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01241591
First received: November 12, 2010
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: CP 690,550 5 mg
Drug: CP 690,550 10 mg
Biological: Etanercept 50 mg
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Physician's Global Assessment (PGA)response ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of participants achieving at least a 75% reduction in Psoriasis Area and Severity Index relative to baseline at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physicians Global Assessment (PGA)response [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Proportion of participants in each Physicians Global Assessment (PGA) category [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in Psoriasis Area And Severity Index (PASI) component scores [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Psoriasis Area And Severity Index (PASI) [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Actual and percent change from baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving at least a 50% and 90% reduction in PASI relative to baseline (PASI50 and PASI90, respectively) [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 75 (PASI75) responses [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Proportion of participants with a PASI score of >=125% of the baseline PASI [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in the Itch Severity Item (ISI) score [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in the Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline, Weeks 4,12 ] [ Designated as safety issue: No ]
  • Short Form-36 (SF-36) - Version 2, Acute [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Psoriasis score (PtGA) [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
  • Patient Satisfaction with Study Medication (PSSM) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Dimension Health State EuroQol (EQ-5D) score at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Psoriasis Health Care Resource Utilization Questionnaire (Ps-HCRU) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Psoriasis Quality of Life score (PQOL-12) at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 1108
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP 690,550 5 mg BID+Placebo BIW Drug: CP 690,550 5 mg
CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Experimental: CP 690,550 10 mg BID+Placebo BIW Drug: CP 690,550 10 mg
CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Active Comparator: Placebo BID+Etanercept 50 mg BIW Biological: Etanercept 50 mg
Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
Placebo Comparator: Placebo BID+Placebo BIW Other: Placebo
Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly 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 had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
  • Have plaque-type psoriasis covering at least 10% of total body surface area
  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis
  • Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
  • Cannot discontinue phototherapy
  • Any uncontrolled significant medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241591

  Show 122 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01241591     History of Changes
Other Study ID Numbers: A3921080
Study First Received: November 12, 2010
Last Updated: February 26, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
CP-690,550
Etanercept
Moderate
Severe
Chronic
Plaque
Psoriasis
Efficacy
Safety

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014