Topical CP-690,550 For Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: Placebo Vehicle
* Drug: Placebo Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic plaque psoriasis, topical treatment