- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02899962
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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British Columbia
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Surrey, British Columbia, Canada, V3R 6A7
- Dr. Chih-ho Hong Medical
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Vancouver, British Columbia, Canada, V6E 4M3
- Pacific Dermaesthetics
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Wiseman Dermatology Research
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New Brunswick
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Bathurst, New Brunswick, Canada, E2A 4Z9
- Maritime Medical Research Centre
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Fredericton, New Brunswick, Canada, E3B 1G9
- Brunwick Dermatology Center
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Ontario
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Ajax, Ontario, Canada, L1S 7K8
- CCA Medical Research
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Hamilton, Ontario, Canada, L8N 1V6
- Dermatrials Research Incorporated
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London, Ontario, Canada, N6A 3B4
- The Guenther Dermatology Research Centre
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Markham, Ontario, Canada, L3P 1X2
- Lynderm Research
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Peterborough, Ontario, Canada, K9J 5K2
- Skin Center for Dermatology
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Waterloo, Ontario, Canada, N2J 1C4
- K. Papp Clinical Research
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Quebec
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Quebec City, Quebec, Canada, J2B 5L4
- Clinique du Dre Isabelle Delorme Inc
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Dresden, Duitsland, 01307
- Klinik und Poliklinik für Dermatologie
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Erlangen, Duitsland, 91054
- Universitätsklinikum Erlangen
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Essen, Duitsland, 54122
- Universitätsklinikum Essen (AöR), Klinik für Dermatologie
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Gera, Duitsland, 07548
- SRH Wald-Klinikum Gera
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Hamburg, Duitsland, 20354
- SCIderm GmbH
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Lubeck, Duitsland, 23538
- UKSH - Campus Lübeck
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Mahlow, Duitsland, 15831
- Michael Sebastian
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Munchen, Duitsland, 80337
- LMU Poliklinik Derma & Allergo
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Schweinfurt, Duitsland, 97421
- Gemein. Weber & Crainic
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Brest, Frankrijk, 29609
- CHRU de Brest - Hôpital Morvan
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Nice, Frankrijk, 06202
- C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
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Rennes, Frankrijk, 35033
- CHU de Rennes - Hopital Pontchaillou
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Valence, Frankrijk, 26000
- Centre Hospitalier de Valence
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Saint-Etienne
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Saint Etienne, Saint-Etienne, Frankrijk, 42055
- C.H.U. de Saint-Etienne Service de Dermatologie
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Kraków, Polen, 31-123
- Małopolskie Centrum Kliniczne
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Lublin, Polen, 20-079
- NZOZ Med-laser
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Poznań, Polen, 60-425
- Solumed
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Rzeszów, Polen, 35-030
- Kliniczny Szpital Wojewódzki, Klinika Dermatologii
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Salford, Verenigd Koninkrijk, M6 8HD
- Dermatopharmacology Department
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Cambridgeshire
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Wansford, Cambridgeshire, Verenigd Koninkrijk, PE8 6PL
- Wansford and Kings Cliffe Prac
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Derbyshire
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Chesterfield, Derbyshire, Verenigd Koninkrijk, S40 4AA
- Ashgate Medical Practice
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Leicstershire
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Burbage, Leicstershire, Verenigd Koninkrijk, LE10 2SE
- Burbage Surgery
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Northamptonshire
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Wellingborough, Northamptonshire, Verenigd Koninkrijk, NN8 4RW
- Albany House Medical Centre
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Warwickshire
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Leamington Spa, Warwickshire, Verenigd Koninkrijk, CV32 4RA
- Sherbourne Medical Centre
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West Yorkshire
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Leeds, West Yorkshire, Verenigd Koninkrijk, LS7 4SA
- Chapel Allerton Hospital
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California
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Fremont, California, Verenigde Staten, 94538
- Center for Dermatology Clinical Research
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Santa Monica, California, Verenigde Staten, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Verenigde Staten, 80210
- Colorado Medical Research Center
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Florida
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Miami, Florida, Verenigde Staten, 33144
- International Dermatology Research
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Illinois
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Arlington Heights, Illinois, Verenigde Staten, 60005
- Arlington Dermatology
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40217
- Derm Research
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Maryland
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Rockville, Maryland, Verenigde Staten, 20850
- Dermassociates
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Michigan
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Clarkston, Michigan, Verenigde Staten, 48346
- Clarkston Skin Research
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Medical Center - New Center One
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Kalamazoo, Michigan, Verenigde Staten, 49009
- Beyer Research
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New Jersey
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East Windsor, New Jersey, Verenigde Staten, 08520
- Psoriasis Treatment Center of Central NJ
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New York
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New York, New York, Verenigde Staten, 10029
- Mount Sinai School of Medicine
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New York, New York, Verenigde Staten, 10075
- Sadick Research Group
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Rochester, New York, Verenigde Staten, 14623
- Skin Search of Rochester
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- UPMC Department of Dermatology
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Tennessee
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Goodlettsville, Tennessee, Verenigde Staten, 37072
- Rivergate Dermatology Clinical Research Center
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Knoxville, Tennessee, Verenigde Staten, 37922
- The Skin Wellness Center
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Nashville, Tennessee, Verenigde Staten, 37215
- Tennessee Clinical Research Center
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Texas
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San Antonio, Texas, Verenigde Staten, 78229
- Clinical Trials of Texas
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Webster, Texas, Verenigde Staten, 77598
- Center for Clinical Studies
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Washington
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Spokane, Washington, Verenigde Staten, 99202
- Premier Clinical Research
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
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LEO 90100 aerosol foam twice weekly
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Placebo-vergelijker: LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
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LEO 90100 aerosol foam vehicle twice weekly
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to First Relapse
Tijdsspanne: From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
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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
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From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Proportion of Days in Remission During the Maintenance Phase
Tijdsspanne: From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
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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
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From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
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Number of Relapses During the Maintenance Phase
Tijdsspanne: From Randomisation (Week 4) until End of Treatment (Week 56)
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Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
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From Randomisation (Week 4) until End of Treatment (Week 56)
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LP0053-1004
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Psoriasis vulgaris
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LEO PharmaVoltooidPlaque Psoriasis | Psoriasis vulgarisDuitsland
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SoligenixWervingPsoriasis | Plaque Psoriasis | Psoriasis vulgarisVerenigde Staten
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LEO PharmaBeëindigdPsoriasis | Plaque Psoriasis | Psoriasis vulgarisBelgië, Duitsland, Italië, Spanje, Denemarken, Oostenrijk, Frankrijk, Griekenland, Zwitserland, Verenigd Koninkrijk, Nederland, Zweden
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Chinese University of Hong KongNog niet aan het wervenPsoriasis vulgaris
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University Hospital, GhentWerving
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University Hospital, GhentWervingPsoriasis vulgarisBelgië
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University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationWervingPsoriasis vulgarisVerenigde Staten
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Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsWerving
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University Hospital, GhentKU Leuven; University GhentWerving
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University of California, San FranciscoNational Psoriasis FoundationWervingPsoriasis | Psoriasis vulgarisVerenigde Staten
Klinische onderzoeken op LEO 90100 aerosol foam
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LEO PharmaVoltooid
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LEO PharmaVoltooidHuid- en bindweefselaandoeningenFrankrijk
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LEO PharmaVoltooid
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LEO PharmaVoltooidPsoriasis vulgarisJapan
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LEO PharmaVoltooid
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LEO PharmaVoltooid
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LEO PharmaVoltooidPsoriasis vulgarisFrankrijk
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LEO PharmaVoltooidHuid- en bindweefselaandoeningenFrankrijk