A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01309737
First received: March 4, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550
Drug: Placebo/CP-690,550
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 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 16 [ Time Frame: week 16 ] [ 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 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in Body Surface Area (BSA) at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 90 (PASI90) response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Quality Index (DLQI) total score to Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Physicians Global Assessment (PGA)response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Index (DLQI) total score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 in participants with nail psoriasis at baseline [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Physicians Global Assessment (PGA) response at Week 52 among participants achieving PGA response at Week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Psoriasis Area Severity Index 75 (PASI75) response at Week 52 among participants achieving PASI75 response at Week 16. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Psoriasis Area Severity Index 90 (PASI90) response at Week 52 among participants achieving PASI90 response at Week 16. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Physicians Global Assessment (PGA) response [ Time Frame: Baseline, Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Baseline, Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Baseline, Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Physicians Global Assessment (PGA) response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants in each Physicians Global Assessment (PGA) category [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in Psoriasis Area and Severity Index (PASI) and PASI component scores [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40 and 52 ] [ Designated as safety issue: No ]
  • Actual and change in baseline in Body Surface Area (BSA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ 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) at various time points through Week 52. [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants with a PASI score > or equal to 125% of the baseline PASI score at any time point through Week 52 [ Time Frame: Weeks 2,4,8,12,16,20,28,40, 52 ] [ Designated as safety issue: No ]
  • Actual and percent change from baseline in Nail Psoriasis Severity Index (NAPSI) and number of affected nails in participants [ Time Frame: Baseline, Weeks 8,16,20,28,40 and 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) in participants with nail psoriasis at baseline. [ Time Frame: Baseline, Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving at least 75% and 100% reduction in Nail Psoriasis Severity Index (NAPSI) relative to baseline (NAPSI75 and NAPSI100, respectively) in participants with nail psoriasis at baseline. [ Time Frame: Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in Itch Severity Item (ISI) score [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in the Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline, Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Short Form 36 Health Survey (SF-36) - Version 2, Acute [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 8,16,28,52 ] [ Designated as safety issue: No ]
  • Work Limitation Questionnaire (WLQ) [ Time Frame: Weeks 8,16,28,52 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (PtGA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Patient Satisfaction with Study Medication (PSSM) [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
  • Joint Pain Assessment (JPA) [ Time Frame: Weeks 8,16,28,52 ] [ Designated as safety issue: No ]
  • Euro Qol 5 Dimensions (EQ-5D) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps HCRU) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
  • Family Dermatology Life Quality Index (FDLQI) [ Time Frame: Weeks 16,52 ] [ Designated as safety issue: No ]

Enrollment: 967
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment 10 mg BID Drug: CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
Experimental: Active Treatment 5 mg BID Drug: CP-690,550
5 mg oral BID, Continuous treatment for 52 Weeks
Placebo Comparator: Placebo Treatment Drug: Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Drug: Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

  Eligibility

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

Inclusion Criteria:

  • 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
  • A Psoriasis Area and Severity Index (PASI) score of 12 or greater
  • Are considered to be candidates for systemic or light therapy
  • Have no evidence of active or latent tuberculosis

Exclusion Criteria:

  • Non-plaque or drug-induced forms of psoriasis
  • Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
  • Any uncontrolled significant medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309737

  Show 94 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: NCT01309737     History of Changes
Other Study ID Numbers: A3921079
Study First Received: March 4, 2011
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chronic
severe
moderate
treatment
safety
efficacy
CP-690,550
Plaque Psoriasis
Psoriasis Vulgaris

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

ClinicalTrials.gov processed this record on April 15, 2014