LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

Completed · Phase 3

Conditions studied: Psoriasis Vulgaris

In brief

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.

Key facts

Study ID

NCT01866163

Run by

LEO Pharma

People needed

426

Starts

2013-06-01

Expected to finish

2013-11-01

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Central Dermatology — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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