Phase 3
Completed N=323
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies
Source: ClinicalTrials.gov NCT00689481 ↗Enrolled (actual)
323
Serious AEs
0.3%
Results posted
Dec 2010
Primary outcomePrimary: Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment — 58; 17 participants — p=0.016
Summary
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment |
58; 17 | 0.016 sig |
| SECONDARY 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 |
67; 22 | 0.034 sig |
| SECONDARY 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 |
72; 20 | 0.004 sig |
| SECONDARY Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 |
42; 12 | 0.052 |
| SECONDARY Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 |
78; 27 | 0.033 sig |
| SECONDARY Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) |
8; 4; 50; 13 | 0.859 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00689481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.