Topical CP-690,550 For Chronic Plaque Psoriasis

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 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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: CP-690,550; Drug: CP-690,550; Drug: Placebo Vehicle; Drug: Placebo Vehicle

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4X7
    • Centre de Recherche dermatologique du Quebec Metropolitain
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Guildford Dermatology Specialists
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research Inc.
  • Ontario
    • Waterloo, Ontario, Canada, N2J 1C4
      • K.Papp Clinical Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research, Inc.
    • Montreal, Quebec, Canada, H3Z 2S6
      • Siena Medical Research
• United States
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0314
      • University of Michigan
  • Minnesota
    • Fridley, Minnesota, United States, 55432-3134
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology, PC
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
    • High Point, North Carolina, United States, 27262
      • The Imaging Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center, Pc
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2% CP-690,550 QD	Drug: CP-690,550; Topical treatment once daily for 28 days; Drug: CP-690,550; Topical treatment twice daily for 28 days
Experimental: 0.2% CP-690,550 QD	Drug: CP-690,550; Topical treatment once daily for 28 days; Drug: CP-690,550; Topical treatment twice daily for 28 days
Experimental: 0.02% CP-690,550 QD	Drug: CP-690,550; Topical treatment once daily for 28 days; Drug: CP-690,550; Topical treatment twice daily for 28 days
Experimental: 2% CP-690,550 BID	Drug: CP-690,550; Topical treatment once daily for 28 days; Drug: CP-690,550; Topical treatment twice daily for 28 days
Experimental: 0.2% CP-690,550 BID	Drug: CP-690,550; Topical treatment once daily for 28 days; Drug: CP-690,550; Topical treatment twice daily for 28 days
Experimental: 0.02% CP-690,550 BID	Drug: CP-690,550; Topical treatment once daily for 28 days; Drug: CP-690,550; Topical treatment twice daily for 28 days
Placebo Comparator: Placebo Vehicle QD	Drug: Placebo Vehicle; Topical treatment once daily for 28 days; Drug: Placebo Vehicle; Topical treatment twice daily for 28 days
Placebo Comparator: Placebo Vehicle BID	Drug: Placebo Vehicle; Topical treatment once daily for 28 days; Drug: Placebo Vehicle; Topical treatment twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	Week 4
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.	Baseline, Week 1, 2, 3
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.	Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Drug Plasma Concentrations of CP-690,555	Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.	0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
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.	Day 28

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2008
• Primary Completion (Actual): July 9, 2009
• Study Completion (Actual): July 24, 2009

Study Registration Dates

• First Submitted: May 13, 2008
• First Submitted That Met QC Criteria: May 13, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: topical treatment; chronic plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.