Last updated: 11/07/2018 08:14:42
Study to compare U0267 against Vehicle in subjects with Plaque-type Psoriasis one of two phase 3 studies
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of Subjects with Treatment Success, assessed per the Investigator's Static Global Assessment (ISGA)
Timeframe: 8 weeks
Secondary outcomes:
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
Timeframe: 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
Timeframe: 8 weeks
Number of subjects with a target lesion score of 0 for plaque thickness at week 8
Timeframe: 8 weeks
Number of subjects who have an ISGA score of 0 or 1 at week 8
Timeframe: 8 weeks
Number of subjects who have treatment success at week 8 analyzed by baseline ISGA (Mild or Moderate)
Timeframe: 8 weeks
Interventions:
Drug: U0267
Drug: Vehicle
Enrollment:
336
Observational study model:
Not applicable
Primary completion date:
2008-19-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Psoriasis
Product
calcipotriol
Collaborators
GSK
Study date(s)
March 2008 to December 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Male or female subjects at least 12 years old and in good general health.
- Mild to moderate plaque-type psoriasis
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
Massachusetts General Hospital Clinical Unit for Research Trials in Skin
Boston, MA, United States, 02114
Status
Study Complete
Location
Minnesota Clinical Study Center
Fridley, MN, United States, 55432
Status
Study Complete
Location
Therapeutics Clinical Research Center, Inc.
San Diego, CA, United States, 92123
Status
Study Complete
Location
Oregon Medical Research Center, P.C.
Portland, OR, United States, 97223
Status
Study Complete
Location
Dermatology Consulting Services
High Point, NC, United States, 27262
Status
Study Complete
Location
Dermatology Treatment & Research Center
Dallas, TX, United States, 75230
Status
Study Complete
Location
Florida Academic Dermatology Centers
Miami, FL, United States, 33136
Status
Study Complete
Location
Dermatology Research Center, Inc.
Salt Lake City, UT, United States, 84124
Status
Study Complete
Location
Mount Sinai School of Medicine, Department of Dermatology
New York, NY, United States, 10029
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-19-12
Actual study completion date
2008-19-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website