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

21. Oktober 2013 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

854

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: 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.
Experimental: Onercept
Arzneimittel: 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)

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

EMD Serono

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2004

Primärer Abschluss (Tatsächlich)

1. Juni 2005

Studienabschluss (Tatsächlich)

1. Juni 2005

Studienanmeldedaten

Zuerst eingereicht

24. August 2004

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. August 2004

Zuerst gepostet (Schätzen)

26. August 2004

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

22. Oktober 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Oktober 2013

Zuletzt verifiziert

1. Oktober 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 24979

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