LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866163
• Other study ID #: LP0053-1001
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100

• Vehicle

Locations

Country	Name	City	State
United States	Central Dermatology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success According to IGA	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.; The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe	4 weeks
Secondary	m-PASI at Week 4	The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).; m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.; The m-PASI score range from 0 (best) to 64.8 (worst).	4 weeks
Secondary	m-PASI at Week 1	The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).; m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.; The m-PASI score range from 0 (best) to 64.8 (worst).	1 week

External Links

•   Clinical Trials at LEO Pharma