LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01866163
First received: May 28, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.


Condition Intervention Phase
Psoriasis Vulgaris
Plaque Psoriasis
Drug: LEO 90100
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Treatment Success according to IGA [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4.


Secondary Outcome Measures:
  • Psoriasis Area Severity Index (a measure combining redness, thickness, scaliness and extent) assessed at week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    m-PASI at Week 4.

  • Psoriasis Area Severity Index (a measure combining redness, thickness, scaliness and extent) assessed at week 1 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    m-PASI at Week 1.


Enrollment: 426
Study Start Date: June 2013
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEO 90100
-
Drug: LEO 90100
Placebo Comparator: Vehicle
Vehicle
Drug: Vehicle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs
  • Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
  • An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day 0 (Visit 1)
  • A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
  • A target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion

Exclusion Criteria:

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

    • etanercept - within 4 weeks prior to randomisation
    • adalimumab, infliximab - within 8 weeks prior to randomisation
    • ustekinumab - within 16 weeks prior to randomisation
    • other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
  • Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
  • PUVA therapy within 4 weeks prior to randomisation.
  • UVB therapy within 2 weeks prior to randomisation.
  • Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation.
  • Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial.
  • Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Previously randomised in this trial or any previously conducted trial of LEO 90100.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866163

Locations
United States, Missouri
Central Dermatology
St. Louis, Missouri, United States, 63117
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Craig Leonardi Central Dermatology
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01866163     History of Changes
Other Study ID Numbers: LP0053-1001
Study First Received: May 28, 2013
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014