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

• 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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  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.
• 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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  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.
• Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  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.
• Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  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.
• Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  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.

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

• Drug: U0267 Foam
  All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
• Drug: Vehicle foam
  All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

• Experimental: U0267 foam
  U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
  Intervention: Drug: U0267 Foam
• Placebo Comparator: Vehicle foam
  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.
  Intervention: Drug: Vehicle foam

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.