Back to resultsLEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LEO 90100 aerosol foam
LEO 90100 aerosol foam vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
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
Sites / Locations
- Center for Dermatology Clinical Research
- Clinical Science Institute
- Colorado Medical Research Center
- International Dermatology Research
- Arlington Dermatology
- Derm Research
- DermAssociates
- Clarkston Skin Research
- Henry Ford Medical Center - New Center One
- Beyer Research
- Psoriasis Treatment Center of Central NJ
- Mount Sinai School of Medicine
- Sadick Research Group
- Skin Search of Rochester
- UPMC Department of Dermatology
- Rivergate Dermatology Clinical Research Center
- The Skin Wellness Center
- Tennessee Clinical Research Center
- Clinical Trials of Texas
- Center for Clinical Studies
- Premier Clinical Research
- Dr. Chih-ho Hong Medical
- Pacific Dermaesthetics
- Wiseman Dermatology Research
- Maritime Medical Research Centre
- Brunwick Dermatology Center
- CCA Medical Research
- Dermatrials Research Incorporated
- The Guenther Dermatology Research Centre
- Lynderm Research
- SKiN Center for Dermatology
- K. Papp Clinical Research
- Clinique du Dre Isabelle Delorme Inc
- C.H.U. de Saint-Etienne Service de Dermatologie
- CHRU de Brest - Hôpital Morvan
- C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
- CHU de Rennes - Hôpital Pontchaillou
- Centre Hospitalier de Valence
- Klinik und Poliklinik für Dermatologie
- Universitätsklinikum Erlangen
- Universitätsklinikum Essen (AöR), Klinik für Dermatologie
- SRH Wald-Klinikum Gera
- SCIderm GmbH
- UKSH - Campus Lübeck
- Michael Sebastian
- LMU Poliklinik Derma & Allergo
- Gemein. Weber & Crainic
- Małopolskie Centrum Kliniczne
- NZOZ Med-laser
- Solumed
- Kliniczny Szpital Wojewódzki, Klinika Dermatologii
- Wansford and Kings Cliffe Prac
- Ashgate Medical Practice
- Burbage Surgery
- Albany House Medical Centre
- Sherbourne Medical Centre
- Chapel Allerton Hospital
- Dermatopharmacology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
LEO 90100 aerosol foam
LEO 90100 aerosol foam vehicle
Arm Description
Topical application twice weekly for 52 weeks
Topical application twice weekly for 52 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Number of Relapses During the Maintenance Phase
Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02899962
Brief Title
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Official Title
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
722 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 90100 aerosol foam
Arm Type
Active Comparator
Arm Description
Topical application twice weekly for 52 weeks
Arm Title
LEO 90100 aerosol foam vehicle
Arm Type
Placebo Comparator
Arm Description
Topical application twice weekly for 52 weeks
Intervention Type
Drug
Intervention Name(s)
LEO 90100 aerosol foam
Intervention Description
LEO 90100 aerosol foam twice weekly
Intervention Type
Drug
Intervention Name(s)
LEO 90100 aerosol foam vehicle
Intervention Description
LEO 90100 aerosol foam vehicle twice weekly
Primary Outcome Measure Information:
Title
Time to First Relapse
Description
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
Time Frame
From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
Secondary Outcome Measure Information:
Title
Proportion of Days in Remission During the Maintenance Phase
Description
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
Time Frame
From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Title
Number of Relapses During the Maintenance Phase
Description
Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
Time Frame
From Randomisation (Week 4) until End of Treatment (Week 56)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lebwohl, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Dermatology Clinical Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Arlington Dermatology
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Derm Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
DermAssociates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Clarkston Skin Research
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Psoriasis Treatment Center of Central NJ
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Skin Search of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
UPMC Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rivergate Dermatology Clinical Research Center
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Dr. Chih-ho Hong Medical
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Pacific Dermaesthetics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 4M3
Country
Canada
Facility Name
Wiseman Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Maritime Medical Research Centre
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4Z9
Country
Canada
Facility Name
Brunwick Dermatology Center
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
Dermatrials Research Incorporated
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3B4
Country
Canada
Facility Name
Lynderm Research
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
SKiN Center for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Clinique du Dre Isabelle Delorme Inc
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
Country
Canada
Facility Name
C.H.U. de Saint-Etienne Service de Dermatologie
City
Saint Etienne
State/Province
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CHRU de Brest - Hôpital Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Klinik und Poliklinik für Dermatologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen (AöR), Klinik für Dermatologie
City
Essen
ZIP/Postal Code
54122
Country
Germany
Facility Name
SRH Wald-Klinikum Gera
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
SCIderm GmbH
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
UKSH - Campus Lübeck
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Michael Sebastian
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
LMU Poliklinik Derma & Allergo
City
Munchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Gemein. Weber & Crainic
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Małopolskie Centrum Kliniczne
City
Kraków
ZIP/Postal Code
31-123
Country
Poland
Facility Name
NZOZ Med-laser
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Solumed
City
Poznań
ZIP/Postal Code
60-425
Country
Poland
Facility Name
Kliniczny Szpital Wojewódzki, Klinika Dermatologii
City
Rzeszów
ZIP/Postal Code
35-030
Country
Poland
Facility Name
Wansford and Kings Cliffe Prac
City
Wansford
State/Province
Cambridgeshire
ZIP/Postal Code
PE8 6PL
Country
United Kingdom
Facility Name
Ashgate Medical Practice
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S40 4AA
Country
United Kingdom
Facility Name
Burbage Surgery
City
Burbage
State/Province
Leicstershire
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
Albany House Medical Centre
City
Wellingborough
State/Province
Northamptonshire
ZIP/Postal Code
NN8 4RW
Country
United Kingdom
Facility Name
Sherbourne Medical Centre
City
Leamington Spa
State/Province
Warwickshire
ZIP/Postal Code
CV32 4RA
Country
United Kingdom
Facility Name
Chapel Allerton Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Dermatopharmacology Department
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35297108
Citation
Guenther L, Takhar A, Megna M, Sebastian M, Nyholm N, Thoning H, Levin LA. Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial. J Eur Acad Dermatol Venereol. 2022 Jul;36(7):1054-1063. doi: 10.1111/jdv.18053. Epub 2022 Mar 28.
Results Reference
derived
PubMed Identifier
34339017
Citation
Lebwohl MG, Papp KA, Morch MH, Bernasconi MYJ, Warren RB. Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics. Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.
Results Reference
derived
PubMed Identifier
32965655
Citation
Stein Gold L, Alonso-Llamazares J, Lacour JP, Warren RB, Tyring SK, Kircik L, Yamauchi P, Lebwohl M; PSO-LONG Trial Investigators. PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis. Adv Ther. 2020 Nov;37(11):4730-4753. doi: 10.1007/s12325-020-01497-6. Epub 2020 Sep 23.
Results Reference
derived
Learn more about this trial
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
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