Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis

21. oktober 2013 oppdatert av: EMD Serono

A Multicentre, Randomised, Double-blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-treatment of Subjects With Moderate to Severe Plaque Psoriasis

The is a double-blind, placebo-controlled, randomized, and multicenter study consisting of a first treatment (FT) period followed by either an observation (OB) period and a re-treatment (RT) period or an open-label (OL) treatment period, depending on FT period response, and a 4-week safety follow-up (FU) period. The purpose of this study is to evaluate the safety and efficacy of onercept, to be administered as 150 milligram (mg) three times a week, compared to matching placebo, for the induction of remission in subjects with moderate to severe plaque psoriasis.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

854

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
      • Edmonton, Alberta, Canada, T5J3S9
        • Probity Medical Research
    • Ontario
      • London, Ontario, Canada, N6A 3H7
        • Guenther Dermatology Research Center
      • Waterloo, Ontario, Canada, N2J 1C4
        • Probity Medical Research
  • Forente stater
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
    • California
      • Fresno, California, Forente stater, 93710
        • Associates in Research Inc.
      • Irvine, California, Forente stater, 92697
        • University of California, Irvine
      • La Jolla, California, Forente stater, 92037
        • Therapeutics Clinical Research
      • San Francisco, California, Forente stater, 94108
        • University of California
      • Santa Monica, California, Forente stater, 90404
        • Clinical Research Specialists Inc.
      • Vallejo, California, Forente stater, 94589
        • Solano Clinical Research
      • Vista, California, Forente stater, 92083
        • Dermatology Specialists Inc
    • Colorado
      • Denver, Colorado, Forente stater, 80210
        • Colorado Medical Research Center
      • Denver, Colorado, Forente stater, 80246
        • Cherry Creek Research, Inc.
      • Longmont, Colorado, Forente stater, 80501
        • Longmont Clinic PC
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06511
        • The Savin Center P.C.
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010
        • Dermatology Associates, P.C. at the Washington Hospital CTR
    • Florida
      • Jacksonville, Florida, Forente stater, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, Forente stater, 32204
        • North Florida Dermatology Associates, P.A.
      • Miami, Florida, Forente stater, 33144
        • International Dermatology Research
    • Georgia
      • Alpharetta, Georgia, Forente stater, 30005
        • Atlanta Dermatology Vein & Research Center
    • Illinois
      • Buffalo Grove, Illinois, Forente stater, 60089
        • Scott D. Glazer, MD
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Department of Dermatology
      • Clinton Township, Michigan, Forente stater, 48038
        • Midwest Cutaneous Research Corporation
    • Minnesota
      • Fridley, Minnesota, Forente stater, 55432
        • Minnesota Clinical Study Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Academic Dermatology Associates
    • North Carolina
      • Winston Salem, North Carolina, Forente stater, 27157
        • Wake Forest Univ School of Medicine
      • Winston Salem, North Carolina, Forente stater, 27103
        • Piedmont Medical Research Associates
    • Oregon
      • Portland, Oregon, Forente stater, 97223
        • Oregon Medical Research Center, P.C.
      • Portland, Oregon, Forente stater, 97210
        • Northwest Cutaneous Research Specialist
    • Tennessee
      • Goodlettsville, Tennessee, Forente stater, 37072
        • Rivergate Dermatology
      • Knoxville, Tennessee, Forente stater, 37917
        • Saint Mary's Centeral Wing Annex
      • Nashville, Tennessee, Forente stater, 37221
        • Tennessee Clinical Research Center
    • Texas
      • Austin, Texas, Forente stater, 78759
        • DermResearch Inc
      • Dallas, Texas, Forente stater, 75230
        • Texas Dermatology Research Institute
      • Houston, Texas, Forente stater, 77030
        • Center for Clinical Studies
      • Houston, Texas, Forente stater, 77058
        • Center for Clinical Studies
      • Houston, Texas, Forente stater, 77030
        • University Texas M.D. Anderson Cancer Center
    • Virginia
      • Norfolk, Virginia, Forente stater, 23507
        • Virginia Clinical Research, Inc
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Dermatology Associates P.L.L.C.
      • Spokane, Washington, Forente stater, 99202
        • Rockwood Clinic, PS

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:

  • Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care
  • At least 18 years of age

  • Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:

    • Being post-menopausal (that is at least 12 months passed last menses) or surgically sterile, or
    • Using an effective form of contraception (that is, condoms, oral contraceptives or intrauterine device) (Confirmation that the subject is not pregnant must be established by a negative urinary human chorionic gonadotrophin test within 7 days before Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterile)
  • An out-patient status at the time of enrollment
  • Plaque psoriasis for at least 12 months
  • Plaque psoriasis covering at least 10 percent of total body surface area and a PASI score of 12.0 or more
  • Candidate for phototherapy or systemic therapy
  • Static Physician's Global Assessment (sPGA) of 3 or more

Exclusion Criteria:

  • Use of more than one Non-steroidal anti-inflammatory drug (NSAID) to treat psoriatic arthritis or having a change in chronic NSAID regimen during the 28 days before Study Day 1 to treat psoriatic arthritis
  • Previous systemic treatment with biologics, including interferon, and/or cytokines/anti cytokines (for example, anti- tumor necrosis factor-alpha, anti-cluster of differentiation [CD]4, interleukin [IL]-10, IL-1ra, anti-CD11a, etc.) within 3 months before Study Day 1
  • Participation in any other investigational study or experimental therapeutic procedure considered to interfere with the study within 3 months before Study Day 1
  • Treatment with any systemic corticosteroids or intra-articular corticosteroid injection during the 28 days before Study Day 1
  • Experimental or off-label treatments for psoriasis and/or psoriatic arthritis such as azathioprine, hydroxyurea / hydroxycarbamide, mycophenolate, chlorambucil, leflunomide or cyclophosphamide within 1 year prior to Study Day 1
  • Treatment with cyclosporin, methotrexate, oral retinoids (that is, acitretin), or fumaric acid esters within 28 days (3 months for acitretin) before Study Day 1
  • Treatment with any topical therapies, such as Vitamin D derivatives, corticosteroids, tars and tar oils, dithranol for chronic or short contact therapy, salicylic acid and topical retinoids, within 14 days before Study Day 1
  • Phototherapy within 28 days before Study Day 1
  • Use of tanning booths within 14 days before Study Day 1
  • Abnormal liver function, defined by a total bilirubin greater than or equal to 1.2 times the upper limit of normal values, (except in the case of Gilbert's syndrome), or aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase levels greater than or equal to 2.5 times the upper limit of normal values

  • Inadequate bone marrow reserve, defined as:

    • Leukocytes less than or equal to 3.5 * 10^9 per liter (/L), or
    • Thrombocytes less than or equal to 100 * 10^9 /L, or
    • Hemoglobin less than or equal to 5 millimole per liter (mmol/L) (8.9 gram per deciliter).
  • Abnormal renal function, defined by serum creatinine greater than 150 micromole per liter.
  • Sero-positivity for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV)
  • Planned major surgery within the treatment period of the study.
  • History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin). Any history of hematopoietic cancer
  • History of active tuberculosis, current active tuberculosis or candidacy for prophylactic therapy for tuberculosis
  • Active severe infection (or non-severe infection at the discretion of the Investigator).
  • History of any opportunistic infection (for example, viral, fungal, protozoal, or bacterial) in the 6 months preceding Study Day 1 related to any clinical condition of immunodeficiency
  • Clinically significant and serious abnormalities on electrocardiography or chest X-ray, (at the discretion of the Investigator)
  • Other serious concomitant disorders incompatible with the study. In particular, subjects with congestive heart failure, prior or current history of blood dyscrasia or central nervous system demyelinating disorders should not be included in the study
  • History of or current drug (including narcotics) abuse, or current active problems with alcohol abuse
  • Requirement for immunization, allergy desensitization or vaccination during the entire study period (it is recommended that these procedures be scheduled at least 14 days prior to Study Day 1 or greater than 3 months after the last injection of study drug), with the exception of killed influenza vaccines which are allowed at any time during the study
  • Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
  • Evidence of skin conditions other than psoriasis (for example, eczema) that would interfere with psoriasis disease assessments
  • Clinically significant psoriasis flares during screening or at the time of enrollment necessitating immediate relief (at the Investigator's discretion)
  • Live or killed virus or bacteria vaccines (within 14 days before Study Day 1) with the exception of killed influenza vaccines which are allowed both prior to Study Day 1 and at any time during the study
  • Bedridden status
  • Previous use of onercept

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo
Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
Eksperimentell: Onercept
Legemiddel: Onercept
Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
Andre navn:
  • recombinant human tumor necrosis factor binding protein-1 (r-hTBP-1)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Tidsramme: Week 12
Week 12
Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52
Tidsramme: Week 52
Week 52

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Tidsramme: Week 12
Week 12
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Tidsramme: Baseline up to Week 12
Baseline up to Week 12
Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score
Tidsramme: Baseline up to Week 12
Baseline up to Week 12
Mean percentage improvement in the itching scale
Tidsramme: Baseline up to Week 12
Baseline up to Week 12
Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12
Tidsramme: Baseline and Week 12
Baseline and Week 12
Median time to relapse
Tidsramme: Week 12 up to Week 36
Week 12 up to Week 36
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 52
Tidsramme: Week 52
Week 52
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Tidsramme: Baseline up to Week 48
Baseline up to Week 48
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52
Tidsramme: Baseline up to Week 52
Baseline up to Week 52
Mean Psoriatic Area and Severity Index (PASI) score
Tidsramme: Week 36 up to Week 52
Week 36 up to Week 52

Samarbeidspartnere og etterforskere

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

Sponsor

EMD Serono

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. september 2004

Primær fullføring (Faktiske)

1. juni 2005

Studiet fullført (Faktiske)

1. juni 2005

Datoer for studieregistrering

Først innsendt

24. august 2004

Først innsendt som oppfylte QC-kriteriene

25. august 2004

Først lagt ut (Anslag)

26. august 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. oktober 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. oktober 2013

Sist bekreftet

1. oktober 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 24979

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. .

Abonnere