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Topical CP-690,550 For Chronic Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-690,550
CP-690,550
CP-690,550
CP-690,550
CP-690,550
CP-690,550
Placebo Vehicle
Placebo Vehicle
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring chronic plaque psoriasis, topical treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having chronic plaque psoriasis for at least 6 months
  • Able to withdraw all prior psoriasis treatments
  • Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

Exclusion Criteria:

  • Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
  • Pregnant or lactating women
  • Unwilling to use appropriate contraceptive methods

Sites / Locations

  • University of California Irvine
  • Therapeutics Clinical Research
  • RUSH University Medical Center
  • Tufts Medical Center
  • University of Michigan
  • Minnesota Clinical Study Center
  • Central Dermatology, PC
  • Dermatology Consulting Services
  • The Imaging Center
  • Wake Forest University Health Sciences
  • Oregon Medical Research Center, PC
  • Oregon Health & Science University
  • DermResearch, Inc.
  • University of Utah School of Medicine
  • Guildford Dermatology Specialists
  • NewLab Clinical Research Inc.
  • K.Papp Clinical Research Inc.
  • Innovaderm Research, Inc.
  • Siena Medical Research
  • Centre de Recherche Dermatologique du Quebec metropolitain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

2% CP-690,550 QD

0.2% CP-690,550 QD

0.02% CP-690,550 QD

2% CP-690,550 BID

0.2% CP-690,550 BID

0.02% CP-690,550 BID

Placebo Vehicle QD

Placebo Vehicle BID

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.

Secondary Outcome Measures

Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions
PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, "clear"; 1, "almost clear"; 2, "mild"; 3, "moderate"; 4 "severe". The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of "clear" and "almost clear".
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Number of Participants With Administration Site Adverse Events
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.
Drug Plasma Concentrations of CP-690,555
Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.
Skin Biopsy Drug Concentrations
Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.

Full Information

First Posted
May 13, 2008
Last Updated
December 4, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00678561
Brief Title
Topical CP-690,550 For Chronic Plaque Psoriasis
Official Title
PHASE 2A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-INDIVIDUAL COMPARISON TRIAL ASSESSING SAFETY, TOLERATION, PHARMACOKINETICS AND PILOT EFFICACY OF 4 WEEKS TREATMENT WITH TOPICAL CP-690,550 IN CHRONIC PLAQUE PSORIASIS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2008 (Actual)
Primary Completion Date
July 9, 2009 (Actual)
Study Completion Date
July 24, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
chronic plaque psoriasis, topical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2% CP-690,550 QD
Arm Type
Experimental
Arm Title
0.2% CP-690,550 QD
Arm Type
Experimental
Arm Title
0.02% CP-690,550 QD
Arm Type
Experimental
Arm Title
2% CP-690,550 BID
Arm Type
Experimental
Arm Title
0.2% CP-690,550 BID
Arm Type
Experimental
Arm Title
0.02% CP-690,550 BID
Arm Type
Experimental
Arm Title
Placebo Vehicle QD
Arm Type
Placebo Comparator
Arm Title
Placebo Vehicle BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Topical treatment once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Topical treatment once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Topical treatment once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Topical treatment twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Topical treatment twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
Topical treatment twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo Vehicle
Intervention Description
Topical treatment once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo Vehicle
Intervention Description
Topical treatment twice daily for 28 days
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
Description
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions
Description
PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, "clear"; 1, "almost clear"; 2, "mild"; 3, "moderate"; 4 "severe". The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of "clear" and "almost clear".
Time Frame
Week 4
Title
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3
Description
TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Time Frame
Baseline, Week 1, 2, 3
Title
Number of Participants With Administration Site Adverse Events
Description
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.
Time Frame
Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Title
Drug Plasma Concentrations of CP-690,555
Description
Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.
Time Frame
0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
Title
Skin Biopsy Drug Concentrations
Description
Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having chronic plaque psoriasis for at least 6 months Able to withdraw all prior psoriasis treatments Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study Exclusion Criteria: Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis Pregnant or lactating women Unwilling to use appropriate contraceptive methods
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
RUSH University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0314
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432-3134
Country
United States
Facility Name
Central Dermatology, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
The Imaging Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oregon Medical Research Center, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Guildford Dermatology Specialists
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
NewLab Clinical Research Inc.
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 2H5
Country
Canada
Facility Name
K.Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Innovaderm Research, Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Siena Medical Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
26267721
Citation
Ports WC, Feldman SR, Gupta P, Tan H, Johnson TR, Bissonnette R. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design. J Drugs Dermatol. 2015 Aug;14(8):777-84.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921038&StudyName=Topical%20CP-690%2C550%20For%20Chronic%20Plaque%20Psoriasis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Topical CP-690,550 For Chronic Plaque Psoriasis

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