LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

Completed · Phase 3

Conditions studied: Psoriasis Vulgaris

In brief

A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris. A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

Key facts

Study ID

NCT02899962

Run by

LEO Pharma

People needed

722

Starts

2017-02-15

Expected to finish

2019-06-26

Last updated by the study team

2020-08-20

Who can join

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

You may qualify if…

• A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs, amenable to treatment with maximum of 100 g of trial medication per week
• 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)
• A target lesion/target location of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), scoring at least 1 ('mild') for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion/Location
• For subjects participating in hypothalamic-pituitary-adrenal (HPA)-axis testing, furthermore:
• An extent of psoriasis vulgaris on trunk and/or limbs of disease severity (PGA) of at least 'moderate' affecting between 10 and 30% of the body surface area (BSA) excluding psoriatic lesions of genitals and skin folds at Visit 1.

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 Visit 1:
• etanercept - within 4 weeks prior to Visit 1
• adalimumab, infliximab - within 8 weeks prior to Visit 1
• ustekinumab - within 16 weeks prior to Visit 1
• secukinumab - within 12 weeks prior to Visit 1
• other products - within 4 weeks/5 half-lives prior to Visit 1 (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 Visit 1
• Systemic treatment with apremilast within 4 weeks prior to Visit 1
• Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1
• Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1
• Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial
• For subjects participating in HPA-axis testing, furthermore:
• Antidepressive medications within 4 weeks prior to Visit 1 or during the trial. Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to baseline

Where it is running

• Clinical Science Institute — Santa Monica, California, United States
• Colorado Medical Research Center — Denver, Colorado, United States
• International Dermatology Research — Miami, Florida, United States
• Arlington Dermatology — Arlington Heights, Illinois, United States
• Derm Research — Louisville, Kentucky, United States
• DermAssociates — Rockville, Maryland, United States
• Clarkston Skin Research — Clarkston, Michigan, United States
• Henry Ford Medical Center - New Center One — Detroit, Michigan, United States
• Beyer Research — Kalamazoo, Michigan, United States
• Psoriasis Treatment Center of Central NJ — East Windsor, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Sadick Research Group — New York, New York, United States
• Skin Search of Rochester — Rochester, New York, United States
• UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States
• Rivergate Dermatology Clinical Research Center — Goodlettsville, Tennessee, United States
• The Skin Wellness Center — Knoxville, Tennessee, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Clinical Trials of Texas — San Antonio, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• Premier Clinical Research — Spokane, Washington, United States
• Dr. Chih-ho Hong Medical — Surrey, British Columbia, Canada
• Pacific Dermaesthetics — Vancouver, British Columbia, Canada
• Wiseman Dermatology Research — Winnipeg, Manitoba, Canada
• Maritime Medical Research Centre — Bathurst, New Brunswick, Canada
• Center for Dermatology Clinical Research — Fremont, California, United States

Full record on ClinicalTrials.gov

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