LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

Phase 3

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: LEO 90100 aerosol foam
Drug: LEO 90100 aerosol foam vehicle

Registration Number: NCT02899962

Lead Sponsor: LEO Pharma

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 722

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 90100 aerosol foam	LEO 90100 aerosol foam	Topical application twice weekly for 52 weeks
LEO 90100 aerosol foam vehicle	LEO 90100 aerosol foam vehicle	Topical application twice weekly for 52 weeks

Primary Outcome Measures

Name	Time	Method
Time to First Relapse	From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)	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

Secondary Outcome Measures

Name	Time	Method
Proportion of Days in Remission During the Maintenance Phase	From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)	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
Number of Relapses During the Maintenance Phase	From Randomisation (Week 4) until End of Treatment (Week 56)	Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product

Trial Locations

Locations (58): Arlington Dermatology
🇺🇸
Arlington Heights, Illinois, United States
Brunwick Dermatology Center
🇨🇦
Fredericton, New Brunswick, Canada
Albany House Medical Centre
🇬🇧
Wellingborough, Northamptonshire, United Kingdom
Solumed
🇵🇱
Poznań, Poland
Skin Search of Rochester
🇺🇸
Rochester, New York, United States
Centre Hospitalier de Valence
🇫🇷
Valence, France
Center for Clinical Studies
🇺🇸
Webster, Texas, United States
Dermatrials Research Incorporated
🇨🇦
Hamilton, Ontario, Canada
Beyer Research
🇺🇸
Kalamazoo, Michigan, United States
Clinical Science Institute
🇺🇸
Santa Monica, California, United States
UPMC Department of Dermatology
🇺🇸
Pittsburgh, Pennsylvania, United States
Sadick Research Group
🇺🇸
New York, New York, United States
Psoriasis Treatment Center of Central NJ
🇺🇸
East Windsor, New Jersey, United States
Dr. Chih-ho Hong Medical
🇨🇦
Surrey, British Columbia, Canada
Rivergate Dermatology Clinical Research Center
🇺🇸
Goodlettsville, Tennessee, United States
Pacific Dermaesthetics
🇨🇦
Vancouver, British Columbia, Canada
SRH Wald-Klinikum Gera
🇩🇪
Gera, Germany
Wiseman Dermatology Research
🇨🇦
Winnipeg, Manitoba, Canada
Maritime Medical Research Centre
🇨🇦
Bathurst, New Brunswick, Canada
CHU de Rennes - Hôpital Pontchaillou
🇫🇷
Rennes, France
Universitätsklinikum Essen (AöR), Klinik für Dermatologie
🇩🇪
Essen, Germany
Klinik und Poliklinik für Dermatologie
🇩🇪
Dresden, Germany
Małopolskie Centrum Kliniczne
🇵🇱
Kraków, Poland
Wansford and Kings Cliffe Prac
🇬🇧
Wansford, Cambridgeshire, United Kingdom
UKSH - Campus Lübeck
🇩🇪
Lubeck, Germany
LMU Poliklinik Derma & Allergo
🇩🇪
Munchen, Germany
NZOZ Med-laser
🇵🇱
Lublin, Poland
Kliniczny Szpital Wojewódzki, Klinika Dermatologii
🇵🇱
Rzeszów, Poland
Gemein. Weber & Crainic
🇩🇪
Schweinfurt, Germany
Chapel Allerton Hospital
🇬🇧
Leeds, West Yorkshire, United Kingdom
Dermatopharmacology Department
🇬🇧
Salford, United Kingdom
International Dermatology Research
🇺🇸
Miami, Florida, United States
Henry Ford Medical Center - New Center One
🇺🇸
Detroit, Michigan, United States
Tennessee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States
CCA Medical Research
🇨🇦
Ajax, Ontario, Canada
The Guenther Dermatology Research Centre
🇨🇦
London, Ontario, Canada
SKiN Center for Dermatology
🇨🇦
Peterborough, Ontario, Canada
C.H.U. de Saint-Etienne Service de Dermatologie
🇫🇷
Saint Etienne, Saint-Etienne, France
Michael Sebastian
🇩🇪
Mahlow, Germany
Center for Dermatology Clinical Research
🇺🇸
Fremont, California, United States
Colorado Medical Research Center
🇺🇸
Denver, Colorado, United States
DermAssociates
🇺🇸
Rockville, Maryland, United States
Derm Research
🇺🇸
Louisville, Kentucky, United States
Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
The Skin Wellness Center
🇺🇸
Knoxville, Tennessee, United States
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
Lynderm Research
🇨🇦
Markham, Ontario, Canada
Clinique du Dre Isabelle Delorme Inc
🇨🇦
Quebec City, Quebec, Canada
CHRU de Brest - Hôpital Morvan
🇫🇷
Brest, France
SCIderm GmbH
🇩🇪
Hamburg, Germany
C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
🇫🇷
Nice, France
Universitätsklinikum Erlangen
🇩🇪
Erlangen, Germany
Ashgate Medical Practice
🇬🇧
Chesterfield, Derbyshire, United Kingdom
Burbage Surgery
🇬🇧
Burbage, Leicstershire, United Kingdom
Sherbourne Medical Centre
🇬🇧
Leamington Spa, Warwickshire, United Kingdom
Clarkston Skin Research
🇺🇸
Clarkston, Michigan, United States
K. Papp Clinical Research
🇨🇦
Waterloo, Ontario, Canada