Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

Official Title
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A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267, Versus Vehicle in Subjects With Plaque-type Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: U0267
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects at least 12 years old and in good general health. Mild to moderate plaque-type psoriasis Exclusion Criteria: Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations History of hypercalcemia or of vitamin D toxicity. Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis. Other serious skin disorder or any chronic medical condition that is not well controlled. Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment. Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment. Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment. Use of any investigational therapy within 4 weeks of enrollment. Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.

Ages Eligible for Study
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Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: U0267 Foam<br>U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. | Drug: U0267<br>* All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).<br>|
| Placebo Comparator: Vehicle foam<br>Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. | Drug: Vehicle<br>* All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 | Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration. | 8 weeks | 
| Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 | Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates. | 8 weeks | 
| Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 | Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more. | 8 weeks | 
| Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. | 8 weeks | 
| Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) | Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque-type Psoriasis, Psoriasis