Clinical trial NCT02899962: LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Official title: LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to First Relapse
timeFrame: From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
Secondary outcomes:
measure: Proportion of Days in Remission During the Maintenance Phase
timeFrame: From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
measure: Number of Relapses During the Maintenance Phase
timeFrame: From Randomisation (Week 4) until End of Treatment (Week 56)
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Arlington Heights
country: United States
facility: Arlington Dermatology
state: Illinois
city: Louisville
country: United States
facility: Derm Research
state: Kentucky
city: Rockville
country: United States
facility: DermAssociates
state: Maryland
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central NJ
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester
state: New York
city: Pittsburgh
country: United States
facility: UPMC Department of Dermatology
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center
state: Tennessee
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research
state: Manitoba
city: Bathurst
country: Canada
facility: Maritime Medical Research Centre
state: New Brunswick
city: Fredericton
country: Canada
facility: Brunwick Dermatology Center
state: New Brunswick
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research Incorporated
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Center for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Quebec City
country: Canada
facility: Clinique du Dre Isabelle Delorme Inc
state: Quebec
city: Saint Etienne
country: France
facility: C.H.U. de Saint-Etienne Service de Dermatologie
state: Saint-Etienne
city: Brest
country: France
facility: CHRU de Brest - Hôpital Morvan
city: Nice
country: France
facility: C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Dermatologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
city: Hamburg
country: Germany
facility: SCIderm GmbH
city: Lubeck
country: Germany
facility: UKSH - Campus Lübeck
city: Mahlow
country: Germany
facility: Michael Sebastian
city: Munchen
country: Germany
facility: LMU Poliklinik Derma & Allergo
city: Schweinfurt
country: Germany
facility: Gemein. Weber & Crainic
city: Kraków
country: Poland
facility: Małopolskie Centrum Kliniczne
city: Lublin
country: Poland
facility: NZOZ Med-laser
city: Poznań
country: Poland
facility: Solumed
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki, Klinika Dermatologii
city: Wansford
country: United Kingdom
facility: Wansford and Kings Cliffe Prac
state: Cambridgeshire
city: Chesterfield
country: United Kingdom
facility: Ashgate Medical Practice
state: Derbyshire
city: Burbage
country: United Kingdom
facility: Burbage Surgery
state: Leicstershire
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre
state: Northamptonshire
city: Leamington Spa
country: United Kingdom
facility: Sherbourne Medical Centre
state: Warwickshire
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
state: West Yorkshire
city: Salford
country: United Kingdom
facility: Dermatopharmacology Department
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mark Lebwohl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.