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Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

1. december 2015 opdateret af: Novartis Pharmaceuticals

Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis

This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Novartis Investigative Site
    • California
      • Pasadena, California, Forenede Stater, 91105
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46256
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63117
        • Novartis Investigative Site
    • New Jersey
      • East Windsor, New Jersey, Forenede Stater, 08520
        • Novartis Investigative Site
      • Verona, New Jersey, Forenede Stater, 07044
        • Novartis Investigative Site
    • New York
      • New York, New York, Forenede Stater, 10065
        • Novartis Investigative Site
      • Rochester, New York, Forenede Stater, 14623
        • Novartis Investigative Site
    • North Carolina
      • High Point, North Carolina, Forenede Stater, 27262
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Novartis Investigative Site
      • Houston, Texas, Forenede Stater, 77030
        • Novartis Investigative Site
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Novartis Investigative Site

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Chronic plaque-type psoriasis diagnosed for at least 6 months
  • Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
  • Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

Exclusion criteria:

  • Forms of psoriasis other than chronic plaque-type
  • Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
  • History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
  • Pregnant or nursing (lactating) women

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Medicin: placebo
placebo komparator
Eksperimentel: secukinumab
Medicin: secukinumab
secukinumab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12
Tidsramme: Baseline, Week 12

Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -

1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Baseline, Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52
Tidsramme: Week 52

Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -

1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Week 52

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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

1. januar 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

17. februar 2012

Først indsendt, der opfyldte QC-kriterier

17. februar 2012

Først opslået (Skøn)

23. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. december 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CAIN457A2223

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, Plaque-type Psoriasis

Kliniske forsøg med placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner