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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

7. august 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

722

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Forente stater
    • California
      • Fremont, California, Forente stater, 94538
        • Center for Dermatology Clinical Research
      • Santa Monica, California, Forente stater, 90404
        • Clinical Science Institute
    • Colorado
      • Denver, Colorado, Forente stater, 80210
        • Colorado Medical Research Center
    • Florida
      • Miami, Florida, Forente stater, 33144
        • International Dermatology Research
    • Illinois
      • Arlington Heights, Illinois, Forente stater, 60005
        • Arlington Dermatology
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40217
        • Derm Research
    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • DermAssociates
    • Michigan
      • Clarkston, Michigan, Forente stater, 48346
        • Clarkston Skin Research
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Medical Center - New Center One
      • Kalamazoo, Michigan, Forente stater, 49009
        • Beyer Research
    • New Jersey
      • East Windsor, New Jersey, Forente stater, 08520
        • Psoriasis Treatment Center of Central NJ
    • New York
      • New York, New York, Forente stater, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Forente stater, 10075
        • Sadick Research Group
      • Rochester, New York, Forente stater, 14623
        • Skin Search of Rochester
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC Department of Dermatology
    • Tennessee
      • Goodlettsville, Tennessee, Forente stater, 37072
        • Rivergate Dermatology Clinical Research Center
      • Knoxville, Tennessee, Forente stater, 37922
        • The Skin Wellness Center
      • Nashville, Tennessee, Forente stater, 37215
        • Tennessee Clinical Research Center
    • Texas
      • San Antonio, Texas, Forente stater, 78229
        • Clinical Trials of Texas
      • Webster, Texas, Forente stater, 77598
        • Center for Clinical Studies
    • Washington
      • Spokane, Washington, Forente stater, 99202
        • Premier Clinical Research
  • Frankrike
      • Brest, Frankrike, 29609
        • CHRU de Brest - Hopital Morvan
      • Nice, Frankrike, 06202
        • C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
      • Rennes, Frankrike, 35033
        • CHU de Rennes - Hopital Pontchaillou
      • Valence, Frankrike, 26000
        • Centre Hospitalier de Valence
    • Saint-Etienne
      • Saint Etienne, Saint-Etienne, Frankrike, 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
  • Storbritannia
      • Salford, Storbritannia, M6 8HD
        • Dermatopharmacology Department
    • Cambridgeshire
      • Wansford, Cambridgeshire, Storbritannia, PE8 6PL
        • Wansford and Kings Cliffe Prac
    • Derbyshire
      • Chesterfield, Derbyshire, Storbritannia, S40 4AA
        • Ashgate Medical Practice
    • Leicstershire
      • Burbage, Leicstershire, Storbritannia, LE10 2SE
        • Burbage Surgery
    • Northamptonshire
      • Wellingborough, Northamptonshire, Storbritannia, NN8 4RW
        • Albany House Medical Centre
    • Warwickshire
      • Leamington Spa, Warwickshire, Storbritannia, CV32 4RA
        • Sherbourne Medical Centre
    • West Yorkshire
      • Leeds, West Yorkshire, Storbritannia, LS7 4SA
        • Chapel Allerton Hospital
  • Tyskland
      • Dresden, Tyskland, 01307
        • Klinik und Poliklinik für Dermatologie
      • Erlangen, Tyskland, 91054
        • Universitatsklinikum 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
Legemiddel: LEO 90100 aerosol foam
LEO 90100 aerosol foam twice weekly
Placebo komparator: LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
Legemiddel: LEO 90100 aerosol foam vehicle
LEO 90100 aerosol foam vehicle twice weekly

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

LEO Pharma

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. februar 2017

Primær fullføring (Faktiske)

26. juni 2019

Studiet fullført (Faktiske)

26. juni 2019

Datoer for studieregistrering

Først innsendt

9. september 2016

Først innsendt som oppfylte QC-kriteriene

13. september 2016

Først lagt ut (Anslag)

14. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2020

Sist bekreftet

1. august 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LP0053-1004

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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