Topical CP-690,550 For Chronic Plaque Psoriasis

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: CP-690,550; Drug: Placebo Vehicle

• Registration Number: NCT00678561
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-13
• Study First Posted: 2008-05-15
• Study Start: 2008-10-13
• Primary Completion: 2009-07-09
• Study Completion: 2009-07-24
• Disposition First Submitted: 2010-08-24
• Disposition First Submitted QC: 2010-11-12
• Disposition First Posted: 2010-11-23
• Status Verified: 2020-12
• Results First Submitted: 2020-12-04
• Results First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-04
• Results First Posted: 2020-12-31
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.02% CP-690,550 BID	CP-690,550	-
0.2% CP-690,550 BID	CP-690,550	-
0.02% CP-690,550 QD	CP-690,550	-
2% CP-690,550 BID	CP-690,550	-
0.2% CP-690,550 QD	CP-690,550	-
Placebo Vehicle QD	Placebo Vehicle	-
Placebo Vehicle BID	Placebo Vehicle	-
2% CP-690,550 QD	CP-690,550	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4	Baseline, 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

Name	Time	Method
Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions	Week 4	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	Baseline, Week 1, 2, 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	Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)	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	0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28	Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.
Skin Biopsy Drug Concentrations	Day 28	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.

Trial Locations

Locations (20)

NewLab Clinical Research Inc.; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Central Dermatology, PC; 🇺🇸 Saint Louis, Missouri, United States

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States

K.Papp Clinical Research Inc.; 🇨🇦 Waterloo, Ontario, Canada

Centre de Recherche Dermatologique du Quebec metropolitain; 🇨🇦 Quebec, Canada

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Innovaderm Research, Inc.; 🇨🇦 Montreal, Quebec, Canada

The Imaging Center; 🇺🇸 High Point, North Carolina, United States

Siena Medical Research; 🇨🇦 Montreal, Quebec, Canada

Guildford Dermatology Specialists; 🇨🇦 Surrey, British Columbia, Canada

RUSH University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Utah School of Medicine; 🇺🇸 Salt Lake City, Utah, United States

University of California Irvine; 🇺🇸 Irvine, California, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Oregon Medical Research Center, PC; 🇺🇸 Portland, Oregon, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States