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

21 oktober 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

854

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Geneesmiddel: 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.
Experimenteel: Onercept
Geneesmiddel: 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.
Andere namen:
  • recombinant human tumor necrosis factor binding protein-1 (r-hTBP-1)

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Tijdsspanne: Week 12
Week 12
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Tijdsspanne: 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
Tijdsspanne: Baseline up to Week 12
Baseline up to Week 12
Mean percentage improvement in the itching scale
Tijdsspanne: 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
Tijdsspanne: Baseline and Week 12
Baseline and Week 12
Median time to relapse
Tijdsspanne: 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
Tijdsspanne: Week 52
Week 52
Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Tijdsspanne: 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
Tijdsspanne: Baseline up to Week 52
Baseline up to Week 52
Mean Psoriatic Area and Severity Index (PASI) score
Tijdsspanne: Week 36 up to Week 52
Week 36 up to Week 52

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

EMD Serono

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2004

Primaire voltooiing (Werkelijk)

1 juni 2005

Studie voltooiing (Werkelijk)

1 juni 2005

Studieregistratiedata

Eerst ingediend

24 augustus 2004

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2004

Eerst geplaatst (Schatting)

26 augustus 2004

Updates van studierecords

Laatste update geplaatst (Schatting)

22 oktober 2013

Laatste update ingediend die voldeed aan QC-criteria

21 oktober 2013

Laatst geverifieerd

1 oktober 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 24979

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