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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1465

Fase

  • Fase 3

Kontakter og lokationer

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

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
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Site Reference ID/Investigator# 6579
      • Birmingham, Alabama, Forenede Stater, 35233
        • Site Reference ID/Investigator# 6697
      • Huntsville, Alabama, Forenede Stater, 35801
        • Site Reference ID/Investigator# 7015
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Site Reference ID/Investigator# 6728
      • Tucson, Arizona, Forenede Stater, 85710
        • Site Reference ID/Investigator# 6584
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Site Reference ID/Investigator# 6696
    • California
      • Bakersfield, California, Forenede Stater, 93309
        • Site Reference ID/Investigator# 6591
      • Fresno, California, Forenede Stater, 93720
        • Site Reference ID/Investigator# 6710
      • Irvine, California, Forenede Stater, 92697
        • Site Reference ID/Investigator# 7885
      • Los Angeles, California, Forenede Stater, 90045
        • Site Reference ID/Investigator# 6872
      • Oceanside, California, Forenede Stater, 92056
        • Site Reference ID/Investigator# 7669
      • San Diego, California, Forenede Stater, 92103
        • Site Reference ID/Investigator# 6821
      • San Diego, California, Forenede Stater, 92117
        • Site Reference ID/Investigator# 6832
      • San Diego, California, Forenede Stater, 92123
        • Site Reference ID/Investigator# 7305
      • San Francisco, California, Forenede Stater, 94118
        • Site Reference ID/Investigator# 7990
      • Santa Monica, California, Forenede Stater, 90404
        • Site Reference ID/Investigator# 6711
      • Torrance, California, Forenede Stater, 90503
        • Site Reference ID/Investigator# 8139
      • Vallejo, California, Forenede Stater, 94589
        • Site Reference ID/Investigator# 7167
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Site Reference ID/Investigator# 7302
      • Longmont, Colorado, Forenede Stater, 80501
        • Site Reference ID/Investigator# 6921
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Site Reference ID/Investigator# 6917
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32204
        • Site Reference ID/Investigator# 6707
      • Miami, Florida, Forenede Stater, 33136
        • Site Reference ID/Investigator# 7301
      • Miami, Florida, Forenede Stater, 33144
        • Site Reference ID/Investigator# 7012
      • Miami, Florida, Forenede Stater, 33173
        • Site Reference ID/Investigator# 6831
      • South Miami, Florida, Forenede Stater, 33143
        • Site Reference ID/Investigator# 7016
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Site Reference ID/Investigator# 6590
    • Georgia
      • Alpharetta, Georgia, Forenede Stater, 30022
        • Site Reference ID/Investigator# 6582
      • Atlanta, Georgia, Forenede Stater, 30327
        • Site Reference ID/Investigator# 7450
      • Newnan, Georgia, Forenede Stater, 30263
        • Site Reference ID/Investigator# 6714
      • Snellville, Georgia, Forenede Stater, 30078
        • Site Reference ID/Investigator# 6717
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
        • Site Reference ID/Investigator# 7017
      • Maywood, Illinois, Forenede Stater, 60153
        • Site Reference ID/Investigator# 7877
      • Skokie, Illinois, Forenede Stater, 60077
        • Site Reference ID/Investigator# 6704
      • West Dundee, Illinois, Forenede Stater, 60118
        • Site Reference ID/Investigator# 7292
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46256
        • Site Reference ID/Investigator# 6706
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Site Reference ID/Investigator# 7646
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66202
        • Site Reference ID/Investigator# 7014
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Site Reference ID/Investigator# 6873
      • Owensboro, Kentucky, Forenede Stater, 42303
        • Site Reference ID/Investigator# 7523
    • Massachusetts
      • Andover, Massachusetts, Forenede Stater, 01810
        • Site Reference ID/Investigator# 6597
      • Boston, Massachusetts, Forenede Stater, 02111
        • Site Reference ID/Investigator# 6703
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Site Reference ID/Investigator# 7644
      • Fort Gratiot, Michigan, Forenede Stater, 48059
        • Site Reference ID/Investigator# 6826
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Site Reference ID/Investigator# 7989
    • Minnesota
      • Fridley, Minnesota, Forenede Stater, 55432
        • Site Reference ID/Investigator# 6581
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • Site Reference ID/Investigator# 7890
      • St. Louis, Missouri, Forenede Stater, 63117
        • Site Reference ID/Investigator# 6709
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68144
        • Site Reference ID/Investigator# 7451
    • New Jersey
      • Berlin, New Jersey, Forenede Stater, 08009
        • Site Reference ID/Investigator# 7299
      • East Windsor, New Jersey, Forenede Stater, 08520
        • Site Reference ID/Investigator# 6924
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Site Reference ID/Investigator# 6577
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Site Reference ID/Investigator# 7030
    • New York
      • Buffalo, New York, Forenede Stater, 14221
        • Site Reference ID/Investigator# 7878
      • New York, New York, Forenede Stater, 10016
        • Site Reference ID/Investigator# 7876
      • New York, New York, Forenede Stater, 10025
        • Site Reference ID/Investigator# 6599
      • New York, New York, Forenede Stater, 10029-6501
        • Site Reference ID/Investigator# 6895
      • New York, New York, Forenede Stater, 10032
        • Site Reference ID/Investigator# 7637
      • Rochester, New York, Forenede Stater, 14623
        • Site Reference ID/Investigator# 7504
      • Stoney Brook, New York, Forenede Stater, 11790
        • Site Reference ID/Investigator# 7018
    • North Carolina
      • Hickory, North Carolina, Forenede Stater, 28601
        • Site Reference ID/Investigator# 6926
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Site Reference ID/Investigator# 7293
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Site Reference ID/Investigator# 8251
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Site Reference ID/Investigator# 6598
      • Cleveland, Ohio, Forenede Stater, 44106
        • Site Reference ID/Investigator# 8082
      • Columbus, Ohio, Forenede Stater, 43212
        • Site Reference ID/Investigator# 7165
      • Dayton, Ohio, Forenede Stater, 45408
        • Site Reference ID/Investigator# 7659
    • Oregon
      • Lake Oswego, Oregon, Forenede Stater, 97035
        • Site Reference ID/Investigator# 6727
      • Portland, Oregon, Forenede Stater, 97210
        • Site Reference ID/Investigator# 6894
      • Portland, Oregon, Forenede Stater, 97223
        • Site Reference ID/Investigator# 6578
      • Portland, Oregon, Forenede Stater, 97239
        • Site Reference ID/Investigator# 7295
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Site Reference ID/Investigator# 7879
      • Philadelphia, Pennsylvania, Forenede Stater, 19103
        • Site Reference ID/Investigator# 6712
    • Rhode Island
      • Johnston, Rhode Island, Forenede Stater, 02919
        • Site Reference ID/Investigator# 6580
      • Providence, Rhode Island, Forenede Stater, 02903
        • Site Reference ID/Investigator# 6576
    • South Carolina
      • Greer, South Carolina, Forenede Stater, 29651
        • Site Reference ID/Investigator# 6589
    • Tennessee
      • Goodlettsville, Tennessee, Forenede Stater, 37072
        • Site Reference ID/Investigator# 6586
      • Knoxville, Tennessee, Forenede Stater, 37934
        • Site Reference ID/Investigator# 7668
      • Nashville, Tennessee, Forenede Stater, 37215
        • Site Reference ID/Investigator# 6915
    • Texas
      • Arlington, Texas, Forenede Stater, 76011
        • Site Reference ID/Investigator# 6825
      • Austin, Texas, Forenede Stater, 78759
        • Site Reference ID/Investigator# 6762
      • Dallas, Texas, Forenede Stater, 75230
        • Site Reference ID/Investigator# 6822
      • Dallas, Texas, Forenede Stater, 75246-1613
        • Site Reference ID/Investigator# 7671
      • Houston, Texas, Forenede Stater, 77030
        • Site Reference ID/Investigator# 6705
      • San Antonio, Texas, Forenede Stater, 78229
        • Site Reference ID/Investigator# 6708
      • San Antonio, Texas, Forenede Stater, 78229
        • Site Reference ID/Investigator# 7081
      • Tyler, Texas, Forenede Stater, 75703
        • Site Reference ID/Investigator# 6912
      • Webster, Texas, Forenede Stater, 77598
        • Site Reference ID/Investigator# 7306
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Site Reference ID/Investigator# 8101
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Site Reference ID/Investigator# 6807
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Site Reference ID/Investigator# 6801
      • Spokane, Washington, Forenede Stater, 99204
        • Site Reference ID/Investigator# 7519
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Site Reference ID/Investigator# 7080

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:

  • 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

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
Placebo komparator: 1
Arm #1 is used for entire study. At week 12, arm is rerandomized.
Medicin: 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.

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

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

Sponsor

AbbVie (prior sponsor, Abbott)

Efterforskere

  • Studiestol: Martin Kaul, MD, AbbVie

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. november 2007

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

7. december 2007

Først indsendt, der opfyldte QC-kriterier

10. december 2007

Først opslået (Skøn)

11. december 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. februar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M06-890

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 Plaque Psoriasis

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United States

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner