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A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis

16. januar 2013 oppdatert av: Centocor Research & Development, Inc.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.

The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Although numerous therapeutic options exist for the treatment of psoriasis, there is still a significant unmet medical need due to the limited effectiveness and/or significant side effect profile of current treatment options. Preclinical studies and early phase clinical studies suggest that interleukins-12 and -23, two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. Ustekinumab (CNTO 1275) is a monoclonal antibody directed against interleukins -12 and -23. This is a randomized (study drug assigned by chance like flipping a coin), double blind (neither physician nor patient knows the name of the assigned drug), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of ustekinumab (CNTO 1275) administered subcutaneously (under the skin) as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The hypothesis is that ustekinumab (CNTO 1275) will be more effective in treatment of psoriasis than placebo, that the improvement in psoriasis will result in an improved quality of life for treated patients and that ustekinumab (CNTO 1275) will be generally well tolerated. Patients will receive ustekinumab (CNTO 1275), 45 or 90 mg, or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52. For patients who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks. Patients will enter long term extension portion of the study at week 52 during which patients will continue to receive treatment with ustekinumab (CNTO 1275) and will be followed for a total of up to 264 weeks from the initial (week 0) administration of study agent.

The dose of ustekinumab (CNTO 1275) will be 45 or 90 mg or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter. For patients who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks.

Studietype

Intervensjonell

Registrering (Faktiske)

1230

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
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Surrey, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • North Bay, Ontario, Canada
      • Toronto, Ontario, Canada
      • Waterloo, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sainte-Foy, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater
    • Arkansas
      • Little Rock, Arkansas, Forente stater
    • California
      • La Jolla, California, Forente stater
      • Los Angeles, California, Forente stater
      • San Diego, California, Forente stater
    • Florida
      • Jacksonville, Florida, Forente stater
      • Miami, Florida, Forente stater
    • Illinois
      • Normal, Illinois, Forente stater
      • Skokie, Illinois, Forente stater
    • Indiana
      • Indianapolis, Indiana, Forente stater
    • Kentucky
      • Louisville, Kentucky, Forente stater
    • Massachusetts
      • Andover, Massachusetts, Forente stater
      • Boston, Massachusetts, Forente stater
    • Michigan
      • Port Huron, Michigan, Forente stater
    • Missouri
      • Saint Louis, Missouri, Forente stater
    • Nevada
      • Las Vegas, Nevada, Forente stater
    • New Jersey
      • New Brunswick, New Jersey, Forente stater
    • New York
      • New York, New York, Forente stater
    • North Carolina
      • Winston Salem, North Carolina, Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater
    • Oregon
      • Portland, Oregon, Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater
      • Plymouth Meeting, Pennsylvania, Forente stater
    • South Carolina
      • Mt. Pleasant, South Carolina, Forente stater
    • Tennessee
      • Nashville, Tennessee, Forente stater
    • Texas
      • Houston, Texas, Forente stater
      • San Antonio, Texas, Forente stater
    • Utah
      • Salt Lake City, Utah, Forente stater
  • Frankrike
      • Nice, Frankrike
  • Storbritannia
      • London, Storbritannia
      • Salford, Storbritannia
      • Southampton Trials Carried Out, Storbritannia
  • Sveits
      • Genève, Sveits
      • Zurich N/A, Sveits
  • Tyskland
      • Berlin, Tyskland
      • Brandenburg, Tyskland
      • Dresden, Tyskland
      • Erlangen, Tyskland
      • Frankfurt, Tyskland
      • Hamburg, Tyskland
      • Kiel, Tyskland
      • Mainz, Tyskland
      • Munchen, Tyskland
  • Østerrike
      • Graz, Østerrike
      • Innsbruck, Østerrike
      • Wien, Østerrike

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:

  • Plaque-type psoriasis diagnosed >= 6 months prior
  • Plaque-type psoriasis covering at least 10% of total body surface areas
  • Psoriasis area-and-severity index score of >=12 at screening and baseline
  • Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
  • Women of childbearing potential and all men must agree to use adequate birth control measures throughout the trials and for 12 months following the last injection of study agent
  • Have no history of latent or active tuberculosis (TB)

Exclusion Criteria:

  • Currently have nonplaque forms of psoriasis or drug-induced psoriasis
  • Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
  • Patients who have used any therapeutic agent targeted at reducing IL-12 or IL-23
  • Patients who have had a Bacillus Calmette-Guerin (BCG) vaccination within the previous 12 months prior to screening
  • Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months prior to screening
  • Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
  • Patients known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
  • Patients participating in another trial using an investigational agent or procedure
  • Systemic immunosuppressants within 4 weeks of the first administration of study agent

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Group I: Placebo
Legemiddel: Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg
Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
Eksperimentell: Group II: Ustekinumab 45 mg
Legemiddel: Ustekinumab (CNTO 1275) 45 mg
Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264
Eksperimentell: Group III: Ustekinumab 90 mg
Legemiddel: Ustekinumab (CNTO 1275) 90 mg
Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12
Tidsramme: Week 0 to Week 12
Number of participants achieving greater than or equal to 75 percent improvement in PASI at Week 12. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Week 0 to Week 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12
Tidsramme: Week 12
Number of participants achieving a physician global assessment (PGA) (0 [none] to 5 [severe]) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).
Week 12
Change in Dermatology Life Quality Index (DLQI) at Week 12
Tidsramme: Baseline to Week 12
Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Baseline to Week 12
Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52
Tidsramme: Week 40 to Week 52
Number of visits at which participants randomized at Week 28 achieved at least 75 percent improvement from baseline in PASI from Week 40 through Week 52 in participants randomized at Week 28. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Week 40 to Week 52

Samarbeidspartnere og etterforskere

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

Sponsor

Centocor Research & Development, Inc.

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

1. mai 2005

Primær fullføring (Faktiske)

1. desember 2006

Studiet fullført (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først innsendt

24. mars 2006

Først innsendt som oppfylte QC-kriteriene

24. mars 2006

Først lagt ut (Anslag)

28. mars 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR006325
  • C0743T09 (Annen identifikator: Centocor R&D, USA)
  • 2005-003530-17 (EudraCT-nummer)

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. .

Kliniske studier på Psoriasis

Kliniske studier på Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg

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