Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

7. august 2020 opdateret af: LEO Pharma

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

722

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Det Forenede Kongerige
      • Salford, Det Forenede Kongerige, M6 8HD
        • Dermatopharmacology Department
    • Cambridgeshire
      • Wansford, Cambridgeshire, Det Forenede Kongerige, PE8 6PL
        • Wansford and Kings Cliffe Prac
    • Derbyshire
      • Chesterfield, Derbyshire, Det Forenede Kongerige, S40 4AA
        • Ashgate Medical Practice
    • Leicstershire
      • Burbage, Leicstershire, Det Forenede Kongerige, LE10 2SE
        • Burbage Surgery
    • Northamptonshire
      • Wellingborough, Northamptonshire, Det Forenede Kongerige, NN8 4RW
        • Albany House Medical Centre
    • Warwickshire
      • Leamington Spa, Warwickshire, Det Forenede Kongerige, CV32 4RA
        • Sherbourne Medical Centre
    • West Yorkshire
      • Leeds, West Yorkshire, Det Forenede Kongerige, LS7 4SA
        • Chapel Allerton Hospital
  • Forenede Stater
    • California
      • Fremont, California, Forenede Stater, 94538
        • Center for Dermatology Clinical Research
      • Santa Monica, California, Forenede Stater, 90404
        • Clinical Science Institute
    • Colorado
      • Denver, Colorado, Forenede Stater, 80210
        • Colorado Medical Research Center
    • Florida
      • Miami, Florida, Forenede Stater, 33144
        • International Dermatology Research
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40217
        • Derm Research
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20850
        • DermAssociates
    • Michigan
      • Clarkston, Michigan, Forenede Stater, 48346
        • Clarkston Skin Research
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Medical Center - New Center One
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Beyer Research
    • New Jersey
      • East Windsor, New Jersey, Forenede Stater, 08520
        • Psoriasis Treatment Center of Central NJ
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Forenede Stater, 10075
        • Sadick Research Group
      • Rochester, New York, Forenede Stater, 14623
        • Skin Search of Rochester
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC Department of Dermatology
    • Tennessee
      • Goodlettsville, Tennessee, Forenede Stater, 37072
        • Rivergate Dermatology Clinical Research Center
      • Knoxville, Tennessee, Forenede Stater, 37922
        • The Skin Wellness Center
      • Nashville, Tennessee, Forenede Stater, 37215
        • Tennessee Clinical Research Center
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • Clinical Trials of Texas
      • Webster, Texas, Forenede Stater, 77598
        • Center for Clinical Studies
    • Washington
      • Spokane, Washington, Forenede Stater, 99202
        • Premier Clinical Research
  • Frankrig
      • Brest, Frankrig, 29609
        • CHRU de Brest - Hopital Morvan
      • Nice, Frankrig, 06202
        • C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
      • Rennes, Frankrig, 35033
        • CHU de Rennes - Hôpital Pontchaillou
      • Valence, Frankrig, 26000
        • Centre Hospitalier de Valence
    • Saint-Etienne
      • Saint Etienne, Saint-Etienne, Frankrig, 42055
        • C.H.U. de Saint-Etienne Service de Dermatologie
  • Polen
      • Kraków, Polen, 31-123
        • Małopolskie Centrum Kliniczne
      • Lublin, Polen, 20-079
        • Nzoz Med-Laser
      • Poznań, Polen, 60-425
        • SOLUMED
      • Rzeszów, Polen, 35-030
        • Kliniczny Szpital Wojewódzki, Klinika Dermatologii
  • Tyskland
      • Dresden, Tyskland, 01307
        • Klinik und Poliklinik für Dermatologie
      • Erlangen, Tyskland, 91054
        • Universitätsklinikum Erlangen
      • Essen, Tyskland, 54122
        • Universitätsklinikum Essen (AöR), Klinik für Dermatologie
      • Gera, Tyskland, 07548
        • SRH Wald-Klinikum Gera
      • Hamburg, Tyskland, 20354
        • SCIderm GmbH
      • Lubeck, Tyskland, 23538
        • UKSH - Campus Lübeck
      • Mahlow, Tyskland, 15831
        • Michael Sebastian
      • Munchen, Tyskland, 80337
        • LMU Poliklinik Derma & Allergo
      • Schweinfurt, Tyskland, 97421
        • Gemein. Weber & Crainic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
Medicin: LEO 90100 aerosol foam
LEO 90100 aerosol foam twice weekly
Placebo komparator: LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
Medicin: LEO 90100 aerosol foam vehicle
LEO 90100 aerosol foam vehicle twice weekly

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Relapse
Tidsramme: 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
From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Days in Remission During the Maintenance Phase
Tidsramme: 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
From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Number of Relapses During the Maintenance Phase
Tidsramme: 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
From Randomisation (Week 4) until End of Treatment (Week 56)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

LEO Pharma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2017

Primær færdiggørelse (Faktiske)

26. juni 2019

Studieafslutning (Faktiske)

26. juni 2019

Datoer for studieregistrering

Først indsendt

9. september 2016

Først indsendt, der opfyldte QC-kriterier

13. september 2016

Først opslået (Skøn)

14. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LP0053-1004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Psoriasis Vulgaris

Kliniske forsøg med LEO 90100 aerosol foam

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Papua New Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner