LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899962
• Other study ID #: LP0053-1004
• Status: Completed
• Phase: Phase 3
• Start date: February 15, 2017
• Est. completion date: June 26, 2019

Study information

• Verified date: August 2020
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

After an initial 4-week period of once-daily treatment with open-label active LEO 90100 aerosol foam, subjects who qualify for randomisation will continue into a 52-week maintenance treatment period with twice-weekly application of randomised LEO 90100 aerosol foam / LEO 90100 aerosol foam vehicle.

If the subject experiences a relapse of psoriasis, the active lesions will be treated for 4 weeks with open-label active LEO 90100 aerosol foam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• 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.

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 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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100 aerosol foam
LEO 90100 aerosol foam twice weekly
• LEO 90100 aerosol foam vehicle
LEO 90100 aerosol foam vehicle twice weekly

Locations

Country	Name	City	State
Canada	CCA Medical Research	Ajax	Ontario
Canada	Maritime Medical Research Centre	Bathurst	New Brunswick
Canada	Brunwick Dermatology Center	Fredericton	New Brunswick
Canada	Dermatrials Research Incorporated	Hamilton	Ontario
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research	Markham	Ontario
Canada	SKiN Center for Dermatology	Peterborough	Ontario
Canada	Clinique du Dre Isabelle Delorme Inc	Quebec City	Quebec
Canada	Dr. Chih-ho Hong Medical	Surrey	British Columbia
Canada	Pacific Dermaesthetics	Vancouver	British Columbia
Canada	K. Papp Clinical Research	Waterloo	Ontario
Canada	Wiseman Dermatology Research	Winnipeg	Manitoba
France	CHRU de Brest - Hôpital Morvan	Brest
France	C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie	Nice
France	CHU de Rennes - Hôpital Pontchaillou	Rennes
France	C.H.U. de Saint-Etienne Service de Dermatologie	Saint Etienne	Saint-Etienne
France	Centre Hospitalier de Valence	Valence
Germany	Klinik und Poliklinik für Dermatologie	Dresden
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Essen (AöR), Klinik für Dermatologie	Essen
Germany	SRH Wald-Klinikum Gera	Gera
Germany	SCIderm GmbH	Hamburg
Germany	UKSH - Campus Lübeck	Lubeck
Germany	Michael Sebastian	Mahlow
Germany	LMU Poliklinik Derma & Allergo	Munchen
Germany	Gemein. Weber & Crainic	Schweinfurt
Poland	Malopolskie Centrum Kliniczne	Kraków
Poland	NZOZ Med-laser	Lublin
Poland	Solumed	Poznan
Poland	Kliniczny Szpital Wojewódzki, Klinika Dermatologii	Rzeszów
United Kingdom	Burbage Surgery	Burbage	Leicstershire
United Kingdom	Ashgate Medical Practice	Chesterfield	Derbyshire
United Kingdom	Sherbourne Medical Centre	Leamington Spa	Warwickshire
United Kingdom	Chapel Allerton Hospital	Leeds	West Yorkshire
United Kingdom	Dermatopharmacology Department	Salford
United Kingdom	Wansford and Kings Cliffe Prac	Wansford	Cambridgeshire
United Kingdom	Albany House Medical Centre	Wellingborough	Northamptonshire
United States	Arlington Dermatology	Arlington Heights	Illinois
United States	Clarkston Skin Research	Clarkston	Michigan
United States	Colorado Medical Research Center	Denver	Colorado
United States	Henry Ford Medical Center - New Center One	Detroit	Michigan
United States	Psoriasis Treatment Center of Central NJ	East Windsor	New Jersey
United States	Center for Dermatology Clinical Research	Fremont	California
United States	Rivergate Dermatology Clinical Research Center	Goodlettsville	Tennessee
United States	Beyer Research	Kalamazoo	Michigan
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Derm Research	Louisville	Kentucky
United States	International Dermatology Research	Miami	Florida
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	Sadick Research Group	New York	New York
United States	UPMC Department of Dermatology	Pittsburgh	Pennsylvania
United States	Skin Search of Rochester	Rochester	New York
United States	DermAssociates	Rockville	Maryland
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Clinical Science Institute	Santa Monica	California
United States	Premier Clinical Research	Spokane	Washington
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Relapse	Time to first relapse (at least 'mild' according to the Physician's Global Assessment of disease severity [PGA]). The investigator was to grade the severity of psoriasis of the trunk and limbs using Physician's global assessment of disease severity 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4	From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
Secondary	Proportion of Days in Remission During the Maintenance Phase	Remission defined as 'clear' or 'almost clear' according to the PGA. The investigator was to grade using a global assessment of the disease severity of psoriasis of the trunk and limbs using the PGA 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4	From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Secondary	Number of Relapses During the Maintenance Phase	Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product	From Randomisation (Week 4) until End of Treatment (Week 56)