LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: LEO 90100 aerosol foam; Drug: LEO 90100 aerosol foam vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 722
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical
    • Vancouver, British Columbia, Canada, V6E 4M3
      • Pacific Dermaesthetics
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4Z9
      • Maritime Medical Research Centre
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Brunwick Dermatology Center
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research
    • Hamilton, Ontario, Canada, L8N 1V6
      • Dermatrials Research Incorporated
    • London, Ontario, Canada, N6A 3B4
      • The Guenther Dermatology Research Centre
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Center for Dermatology
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
  • Quebec
    • Quebec City, Quebec, Canada, J2B 5L4
      • Clinique du Dre Isabelle Delorme Inc
• France
  • Brest, France, 29609
    • CHRU de Brest - Hopital Morvan
  • Nice, France, 06202
    • C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
  • Rennes, France, 35033
    • CHU de Rennes - Hôpital Pontchaillou
  • Valence, France, 26000
    • Centre Hospitalier de Valence
  • Saint-Etienne
    • Saint Etienne, Saint-Etienne, France, 42055
      • C.H.U. de Saint-Etienne Service de Dermatologie
• Germany
  • Dresden, Germany, 01307
    • Klinik und Poliklinik für Dermatologie
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Essen, Germany, 54122
    • Universitätsklinikum Essen (AöR), Klinik für Dermatologie
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera
  • Hamburg, Germany, 20354
    • SCIderm GmbH
  • Lubeck, Germany, 23538
    • UKSH - Campus Lübeck
  • Mahlow, Germany, 15831
    • Michael Sebastian
  • Munchen, Germany, 80337
    • LMU Poliklinik Derma & Allergo
  • Schweinfurt, Germany, 97421
    • Gemein. Weber & Crainic
• Poland
  • Kraków, Poland, 31-123
    • Małopolskie Centrum Kliniczne
  • Lublin, Poland, 20-079
    • Nzoz Med-Laser
  • Poznań, Poland, 60-425
    • SOLUMED
  • Rzeszów, Poland, 35-030
    • Kliniczny Szpital Wojewódzki, Klinika Dermatologii
• United Kingdom
  • Salford, United Kingdom, M6 8HD
    • Dermatopharmacology Department
  • Cambridgeshire
    • Wansford, Cambridgeshire, United Kingdom, PE8 6PL
      • Wansford and Kings Cliffe Prac
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom, S40 4AA
      • Ashgate Medical Practice
  • Leicstershire
    • Burbage, Leicstershire, United Kingdom, LE10 2SE
      • Burbage Surgery
  • Northamptonshire
    • Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
      • Albany House Medical Centre
  • Warwickshire
    • Leamington Spa, Warwickshire, United Kingdom, CV32 4RA
      • Sherbourne Medical Centre
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS7 4SA
      • Chapel Allerton Hospital
• United States
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Arlington Dermatology
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Derm Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Clarkston Skin Research
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center - New Center One
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central NJ
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10075
      • Sadick Research Group
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Dermatology
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology Clinical Research Center
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LEO 90100 aerosol foam; Topical application twice weekly for 52 weeks	Drug: LEO 90100 aerosol foam; LEO 90100 aerosol foam twice weekly
Placebo Comparator: LEO 90100 aerosol foam vehicle; Topical application twice weekly for 52 weeks	Drug: LEO 90100 aerosol foam vehicle; LEO 90100 aerosol foam vehicle twice weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: LEO Pharma

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: LP0053-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No