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

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GSK study ID
114741
See study documents
Clinicaltrials.gov ID
NCT00688519
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2008-19-12
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    Massachusetts General Hospital Clinical Unit for Research Trials in Skin
    Boston, MA, United States, 02114
    Status
    Study Complete
    Contact us
    Location
    Minnesota Clinical Study Center
    Fridley, MN, United States, 55432
    Status
    Study Complete
    Contact us
    Location
    Therapeutics Clinical Research Center, Inc.
    San Diego, CA, United States, 92123
    Status
    Study Complete
    Contact us
    Location
    Oregon Medical Research Center, P.C.
    Portland, OR, United States, 97223
    Status
    Study Complete
    Contact us
    Location
    Dermatology Consulting Services
    High Point, NC, United States, 27262
    Status
    Study Complete
    Contact us
    Location
    The Center for Skin Research
    Houston, TX, United States, 77056
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 13 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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

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