Status:
COMPLETED
LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT01866163
Start Date
June 1 2013
End Date
November 1 2013
Last Update
March 10 2025
Active Locations (1)
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1
Central Dermatology
St Louis, Missouri, United States, 63117