CP-690-550 Ointment For Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01246583
First received: November 22, 2010
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550 Ointment 1
Drug: Vehicle 1
Drug: CP-690,550 Ointment 2
Drug: Vehicle 2
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 2a, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Pilot Efficacy, Safety, And Pharmacokinetics Of 2 Ointment Formulations Of CP-690,550 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent change from baseline at Week 4 in Target Plaque Severity Score (TPSS) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with Treatment Area Overall Severity of Psoriasis response of "clear" (0) or "almost clear" (1) at Weeks 1, 2, 3 and 4; [ Time Frame: 1-4 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with a difference from baseline of >= 2 steps in Treatment Area Overall Severity of Psoriasis score at Weeks 1, 2, 3 and 4 [ Time Frame: 1-4 Weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline at Weeks 1, 2, 3 and 4 in Target Plaque Area [ Time Frame: 1-4 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline at Weeks 1, 2, 3 and 4 in TPSS subscores for Erythema, Induration and Scaling [ Time Frame: 1-4 Weeks ] [ Designated as safety issue: No ]
  • Percent change from Baseline in TPSS at Weeks 1, 2 and 3 [ Time Frame: 1-3 Weeks ] [ Designated as safety issue: No ]
  • Actual and change from baseline on the treatment area Itch Severity Item (ISI) at Weeks 1, 2, 3 and 4 [ Time Frame: 1-4 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects in each Patient Satisfaction with Study Medication (PSSM) response category at Week 4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Incidence, nature and severity of observed and reported administration site adverse events over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence and severity of burning /stinging of psoriatic or perilesional skin in the treatment area over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence and severity of reactions of perilesional skin in the treatment area as measured by Draize scoring over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence and severity of adverse events over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of clinical laboratory abnormalities and change from baseline in clinical laboratory values over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of clinically significant changes in physical examination from baseline over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of vital sign (blood pressure and heart rate) abnormalities and change from baseline in vital sign measures over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measures over 4 weeks of treatment [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Plasma CP-690,550 concentrations, from blood sampling at Week 4 (Day 29) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A Drug: CP-690,550 Ointment 1
2% CP-690,550 Ointment 1 twice daily for 4 weeks
Placebo Comparator: Treatment Group B Drug: Vehicle 1
Vehicle 1 twice daily for 4 weeks
Experimental: Treatment Group C Drug: CP-690,550 Ointment 2
2% CP-690,550 Ointment 2 twice daily for 4 weeks
Placebo Comparator: Treatment Group D Drug: Vehicle 2
Vehicle 2 twice daily for 4 weeks

  Eligibility

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

Inclusion Criteria:

  • Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
  • A target plaque of at least 9 sq. cm.

Exclusion Criteria:

  • Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
  • Non plaque form of psoriasis;
  • Currently have or history of psoriatic arthritis;
  • Current drug induced psoriasis;
  • Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
  • Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months
  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: NCT01246583

Locations
United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36606
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90045
United States, Florida
Pfizer Investigational Site
Orange Park, Florida, United States, 32073
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68144
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, South Dakota
Pfizer Investigational Site
Rapid City, South Dakota, United States, 57702
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Canada, Ontario
Pfizer Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Pfizer Investigational Site
Montreal, Quebec, Canada, H3Z 2S6
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4X7
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: NCT01246583     History of Changes
Other Study ID Numbers: A3921116
Study First Received: November 22, 2010
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Multi Site
Randomized
Placebo Controlled
Double Blind
Parallel Group
chronic plaque psoriasis
topical treatment
skin diseases
papulosquamous

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

ClinicalTrials.gov processed this record on August 20, 2014