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A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

6. februar 2013 oppdatert av: AbbVie (prior sponsor, Abbott)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1465

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
      • Barrie, Canada, L4M 6L2
        • Site Reference ID/Investigator# 7314
      • Calgary, Canada, T3A 2N1
        • Site Reference ID/Investigator# 7452
      • Edmonton, Canada, T5K 1X3
        • Site Reference ID/Investigator# 6702
      • Halifax, Canada, B3H 0A2
        • Site Reference ID/Investigator# 6716
      • Hamilton, Canada, L8N 1V6
        • Site Reference ID/Investigator# 7309
      • Laval, Canada, H7S 2C6
        • Site Reference ID/Investigator# 6588
      • London, Canada, N5X 2P1
        • Site Reference ID/Investigator# 6715
      • London, Canada, N6A 3H7
        • Site Reference ID/Investigator# 7315
      • Markham, Canada, L3P 1A8
        • Site Reference ID/Investigator# 7636
      • Montreal, Canada, H2K 4L5
        • Site Reference ID/Investigator# 6699
      • Montreal, Canada, H3H 1V4
        • Site Reference ID/Investigator# 7316
      • North Bay, Canada, P1B 3Z7
        • Site Reference ID/Investigator# 7088
      • Ottawa, Canada, K2G 6E2
        • Site Reference ID/Investigator# 7310
      • Quebec City, Canada, G1V 4X7
        • Site Reference ID/Investigator# 7311
      • St. John's, Canada, A1A 5E8
        • Site Reference ID/Investigator# 7313
      • Surrey, Canada, V3R 6A7
        • Site Reference ID/Investigator# 7317
      • Vancouver, Canada, V5Z 3Y1
        • Site Reference ID/Investigator# 7308
      • Vancouver, Canada, V5Z 4E8
        • Site Reference ID/Investigator# 6713
      • Waterloo, Canada, N2J 1C4
        • Site Reference ID/Investigator# 7067
      • Westmount, Canada, H3Z 2S6
        • Site Reference ID/Investigator# 7312
      • Windsor, Canada, N8W 1E6
        • Site Reference ID/Investigator# 7087
      • Windsor, Canada, N8W 5L7
        • Site Reference ID/Investigator# 6805
      • Winnipeg, Canada, R3C 1R4
        • Site Reference ID/Investigator# 7638
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • Site Reference ID/Investigator# 6579
      • Birmingham, Alabama, Forente stater, 35233
        • Site Reference ID/Investigator# 6697
      • Huntsville, Alabama, Forente stater, 35801
        • Site Reference ID/Investigator# 7015
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85251
        • Site Reference ID/Investigator# 6728
      • Tucson, Arizona, Forente stater, 85710
        • Site Reference ID/Investigator# 6584
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Site Reference ID/Investigator# 6696
    • California
      • Bakersfield, California, Forente stater, 93309
        • Site Reference ID/Investigator# 6591
      • Fresno, California, Forente stater, 93720
        • Site Reference ID/Investigator# 6710
      • Irvine, California, Forente stater, 92697
        • Site Reference ID/Investigator# 7885
      • Los Angeles, California, Forente stater, 90045
        • Site Reference ID/Investigator# 6872
      • Oceanside, California, Forente stater, 92056
        • Site Reference ID/Investigator# 7669
      • San Diego, California, Forente stater, 92103
        • Site Reference ID/Investigator# 6821
      • San Diego, California, Forente stater, 92117
        • Site Reference ID/Investigator# 6832
      • San Diego, California, Forente stater, 92123
        • Site Reference ID/Investigator# 7305
      • San Francisco, California, Forente stater, 94118
        • Site Reference ID/Investigator# 7990
      • Santa Monica, California, Forente stater, 90404
        • Site Reference ID/Investigator# 6711
      • Torrance, California, Forente stater, 90503
        • Site Reference ID/Investigator# 8139
      • Vallejo, California, Forente stater, 94589
        • Site Reference ID/Investigator# 7167
    • Colorado
      • Denver, Colorado, Forente stater, 80209
        • Site Reference ID/Investigator# 7302
      • Longmont, Colorado, Forente stater, 80501
        • Site Reference ID/Investigator# 6921
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06511
        • Site Reference ID/Investigator# 6917
    • Florida
      • Jacksonville, Florida, Forente stater, 32204
        • Site Reference ID/Investigator# 6707
      • Miami, Florida, Forente stater, 33136
        • Site Reference ID/Investigator# 7301
      • Miami, Florida, Forente stater, 33144
        • Site Reference ID/Investigator# 7012
      • Miami, Florida, Forente stater, 33173
        • Site Reference ID/Investigator# 6831
      • South Miami, Florida, Forente stater, 33143
        • Site Reference ID/Investigator# 7016
      • West Palm Beach, Florida, Forente stater, 33407
        • Site Reference ID/Investigator# 6590
    • Georgia
      • Alpharetta, Georgia, Forente stater, 30022
        • Site Reference ID/Investigator# 6582
      • Atlanta, Georgia, Forente stater, 30327
        • Site Reference ID/Investigator# 7450
      • Newnan, Georgia, Forente stater, 30263
        • Site Reference ID/Investigator# 6714
      • Snellville, Georgia, Forente stater, 30078
        • Site Reference ID/Investigator# 6717
    • Illinois
      • Arlington Heights, Illinois, Forente stater, 60005
        • Site Reference ID/Investigator# 7017
      • Maywood, Illinois, Forente stater, 60153
        • Site Reference ID/Investigator# 7877
      • Skokie, Illinois, Forente stater, 60077
        • Site Reference ID/Investigator# 6704
      • West Dundee, Illinois, Forente stater, 60118
        • Site Reference ID/Investigator# 7292
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46256
        • Site Reference ID/Investigator# 6706
      • Indianapolis, Indiana, Forente stater, 46260
        • Site Reference ID/Investigator# 7646
    • Kansas
      • Overland Park, Kansas, Forente stater, 66202
        • Site Reference ID/Investigator# 7014
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • Site Reference ID/Investigator# 6873
      • Owensboro, Kentucky, Forente stater, 42303
        • Site Reference ID/Investigator# 7523
    • Massachusetts
      • Andover, Massachusetts, Forente stater, 01810
        • Site Reference ID/Investigator# 6597
      • Boston, Massachusetts, Forente stater, 02111
        • Site Reference ID/Investigator# 6703
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Site Reference ID/Investigator# 7644
      • Fort Gratiot, Michigan, Forente stater, 48059
        • Site Reference ID/Investigator# 6826
      • Grand Blanc, Michigan, Forente stater, 48439
        • Site Reference ID/Investigator# 7989
    • Minnesota
      • Fridley, Minnesota, Forente stater, 55432
        • Site Reference ID/Investigator# 6581
    • Missouri
      • St. Louis, Missouri, Forente stater, 63110
        • Site Reference ID/Investigator# 7890
      • St. Louis, Missouri, Forente stater, 63117
        • Site Reference ID/Investigator# 6709
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68144
        • Site Reference ID/Investigator# 7451
    • New Jersey
      • Berlin, New Jersey, Forente stater, 08009
        • Site Reference ID/Investigator# 7299
      • East Windsor, New Jersey, Forente stater, 08520
        • Site Reference ID/Investigator# 6924
      • New Brunswick, New Jersey, Forente stater, 08903
        • Site Reference ID/Investigator# 6577
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Site Reference ID/Investigator# 7030
    • New York
      • Buffalo, New York, Forente stater, 14221
        • Site Reference ID/Investigator# 7878
      • New York, New York, Forente stater, 10016
        • Site Reference ID/Investigator# 7876
      • New York, New York, Forente stater, 10025
        • Site Reference ID/Investigator# 6599
      • New York, New York, Forente stater, 10029-6501
        • Site Reference ID/Investigator# 6895
      • New York, New York, Forente stater, 10032
        • Site Reference ID/Investigator# 7637
      • Rochester, New York, Forente stater, 14623
        • Site Reference ID/Investigator# 7504
      • Stoney Brook, New York, Forente stater, 11790
        • Site Reference ID/Investigator# 7018
    • North Carolina
      • Hickory, North Carolina, Forente stater, 28601
        • Site Reference ID/Investigator# 6926
      • Wilmington, North Carolina, Forente stater, 28401
        • Site Reference ID/Investigator# 7293
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Site Reference ID/Investigator# 8251
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Site Reference ID/Investigator# 6598
      • Cleveland, Ohio, Forente stater, 44106
        • Site Reference ID/Investigator# 8082
      • Columbus, Ohio, Forente stater, 43212
        • Site Reference ID/Investigator# 7165
      • Dayton, Ohio, Forente stater, 45408
        • Site Reference ID/Investigator# 7659
    • Oregon
      • Lake Oswego, Oregon, Forente stater, 97035
        • Site Reference ID/Investigator# 6727
      • Portland, Oregon, Forente stater, 97210
        • Site Reference ID/Investigator# 6894
      • Portland, Oregon, Forente stater, 97223
        • Site Reference ID/Investigator# 6578
      • Portland, Oregon, Forente stater, 97239
        • Site Reference ID/Investigator# 7295
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater, 17033
        • Site Reference ID/Investigator# 7879
      • Philadelphia, Pennsylvania, Forente stater, 19103
        • Site Reference ID/Investigator# 6712
    • Rhode Island
      • Johnston, Rhode Island, Forente stater, 02919
        • Site Reference ID/Investigator# 6580
      • Providence, Rhode Island, Forente stater, 02903
        • Site Reference ID/Investigator# 6576
    • South Carolina
      • Greer, South Carolina, Forente stater, 29651
        • Site Reference ID/Investigator# 6589
    • Tennessee
      • Goodlettsville, Tennessee, Forente stater, 37072
        • Site Reference ID/Investigator# 6586
      • Knoxville, Tennessee, Forente stater, 37934
        • Site Reference ID/Investigator# 7668
      • Nashville, Tennessee, Forente stater, 37215
        • Site Reference ID/Investigator# 6915
    • Texas
      • Arlington, Texas, Forente stater, 76011
        • Site Reference ID/Investigator# 6825
      • Austin, Texas, Forente stater, 78759
        • Site Reference ID/Investigator# 6762
      • Dallas, Texas, Forente stater, 75230
        • Site Reference ID/Investigator# 6822
      • Dallas, Texas, Forente stater, 75246-1613
        • Site Reference ID/Investigator# 7671
      • Houston, Texas, Forente stater, 77030
        • Site Reference ID/Investigator# 6705
      • San Antonio, Texas, Forente stater, 78229
        • Site Reference ID/Investigator# 6708
      • San Antonio, Texas, Forente stater, 78229
        • Site Reference ID/Investigator# 7081
      • Tyler, Texas, Forente stater, 75703
        • Site Reference ID/Investigator# 6912
      • Webster, Texas, Forente stater, 77598
        • Site Reference ID/Investigator# 7306
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • Site Reference ID/Investigator# 8101
    • Virginia
      • Norfolk, Virginia, Forente stater, 23507
        • Site Reference ID/Investigator# 6807
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Site Reference ID/Investigator# 6801
      • Spokane, Washington, Forente stater, 99204
        • Site Reference ID/Investigator# 7519
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53209
        • Site Reference ID/Investigator# 7080

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:

  • Subject is >= 18 years of age
  • Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
  • Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

  • Subject has previous exposure to systemic anti-IL 12 therapy
  • Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
  • Subject is taking or requires oral or injectible corticosteroids
  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant

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
Placebo komparator: 1
Arm #1 is used for entire study. At week 12, arm is rerandomized.
Legemiddel: Placebo
Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
Aktiv komparator: 2
Arm #2 is used for entire study. At week 12, arm is rerandomized.
Biologisk: ABT-874
200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
Biologisk: ABT-874
100mg every 12 weeks.
Aktiv komparator: 3
Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
Biologisk: ABT-874
200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
Biologisk: ABT-874
100mg every 12 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
PGA
Tidsramme: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12
Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12
PASI
Tidsramme: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12
Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12
PGA
Tidsramme: Proportion of subjects maintaining a PGA 0/1 response at Week 52
Proportion of subjects maintaining a PGA 0/1 response at Week 52

Sekundære resultatmål

Resultatmål
Tidsramme
DLQI
Tidsramme: Change from Baseline in DLQI total score vs. placebo at Week 12
Change from Baseline in DLQI total score vs. placebo at Week 12
NAPSI
Tidsramme: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
% change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
PASI
Tidsramme: Subjects who achieve PASI 90 and 100 at Week 12
Subjects who achieve PASI 90 and 100 at Week 12
Safety parameters
Tidsramme: Throughout study
Throughout study

Samarbeidspartnere og etterforskere

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

Sponsor

AbbVie (prior sponsor, Abbott)

Etterforskere

  • Studiestol: Martin Kaul, MD, AbbVie

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

1. november 2007

Primær fullføring (Faktiske)

1. juni 2009

Studiet fullført (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først innsendt

7. desember 2007

Først innsendt som oppfylte QC-kriteriene

10. desember 2007

Først lagt ut (Anslag)

11. desember 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. februar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. februar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • M06-890

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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