Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis
21 octobre 2013 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
854
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alberta
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Edmonton, Alberta, Canada, T5J3S9
- Probity Medical Research
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Ontario
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London, Ontario, Canada, N6A 3H7
- Guenther Dermatology Research Center
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Waterloo, Ontario, Canada, N2J 1C4
- Probity Medical Research
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
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California
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Fresno, California, États-Unis, 93710
- Associates in Research Inc.
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Irvine, California, États-Unis, 92697
- University of California, Irvine
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La Jolla, California, États-Unis, 92037
- Therapeutics Clinical Research
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San Francisco, California, États-Unis, 94108
- University of California
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Santa Monica, California, États-Unis, 90404
- Clinical Research Specialists Inc.
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Vallejo, California, États-Unis, 94589
- Solano Clinical Research
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Vista, California, États-Unis, 92083
- Dermatology Specialists Inc
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Colorado
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Denver, Colorado, États-Unis, 80210
- Colorado Medical Research Center
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Denver, Colorado, États-Unis, 80246
- Cherry Creek Research, Inc.
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Longmont, Colorado, États-Unis, 80501
- Longmont Clinic PC
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Connecticut
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New Haven, Connecticut, États-Unis, 06511
- The Savin Center P.C.
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010
- Dermatology Associates, P.C. at the Washington Hospital CTR
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Florida
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Jacksonville, Florida, États-Unis, 32216
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, États-Unis, 32204
- North Florida Dermatology Associates, P.A.
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Miami, Florida, États-Unis, 33144
- International Dermatology Research
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Georgia
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Alpharetta, Georgia, États-Unis, 30005
- Atlanta Dermatology Vein & Research Center
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Illinois
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Buffalo Grove, Illinois, États-Unis, 60089
- Scott D. Glazer, MD
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan Department of Dermatology
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Clinton Township, Michigan, États-Unis, 48038
- Midwest Cutaneous Research Corporation
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Minnesota
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Fridley, Minnesota, États-Unis, 55432
- Minnesota Clinical Study Center
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87106
- Academic Dermatology Associates
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North Carolina
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Winston Salem, North Carolina, États-Unis, 27157
- Wake Forest Univ School of Medicine
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Winston Salem, North Carolina, États-Unis, 27103
- Piedmont Medical Research Associates
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Oregon
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Portland, Oregon, États-Unis, 97223
- Oregon Medical Research Center, P.C.
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Portland, Oregon, États-Unis, 97210
- Northwest Cutaneous Research Specialist
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Tennessee
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Goodlettsville, Tennessee, États-Unis, 37072
- Rivergate Dermatology
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Knoxville, Tennessee, États-Unis, 37917
- Saint Mary's Centeral Wing Annex
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Nashville, Tennessee, États-Unis, 37221
- Tennessee Clinical Research Center
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Texas
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Austin, Texas, États-Unis, 78759
- DermResearch Inc
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Dallas, Texas, États-Unis, 75230
- Texas Dermatology Research Institute
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Houston, Texas, États-Unis, 77030
- Center for Clinical Studies
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Houston, Texas, États-Unis, 77058
- Center for Clinical Studies
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Houston, Texas, États-Unis, 77030
- University Texas M.D. Anderson Cancer Center
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Virginia
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Norfolk, Virginia, États-Unis, 23507
- Virginia Clinical Research, Inc
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Washington
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Seattle, Washington, États-Unis, 98101
- Dermatology Associates P.L.L.C.
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Spokane, Washington, États-Unis, 99202
- Rockwood Clinic, PS
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Placebo
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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.
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Expérimental: Onercept
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 12
Délai: Week 12
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Week 12
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Percentage of subjects with at least a 75 percent improvement in Psoriatic Area and Severity Index (PASI) score at Week 52
Délai: Week 52
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Week 52
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Délai: Week 12
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Week 12
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Délai: Baseline up to Week 12
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Baseline up to Week 12
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Percentage of subjects with at least a 90 percent improvement in the Psoriatic Area and Severity Index (PASI) score
Délai: Baseline up to Week 12
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Baseline up to Week 12
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Mean percentage improvement in the itching scale
Délai: Baseline up to Week 12
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Baseline up to Week 12
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Change from Baseline in Mean improvement of Dermatology Life Quality Index (DLQI) quality of life assessment at Week 12
Délai: Baseline and Week 12
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Baseline and Week 12
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Median time to relapse
Délai: Week 12 up to Week 36
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Week 12 up to Week 36
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 52
Délai: Week 52
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Week 52
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Délai: Baseline up to Week 48
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Baseline up to Week 48
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score up to Week 52
Délai: Baseline up to Week 52
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Baseline up to Week 52
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Mean Psoriatic Area and Severity Index (PASI) score
Délai: Week 36 up to Week 52
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Week 36 up to Week 52
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2004
Achèvement primaire (Réel)
1 juin 2005
Achèvement de l'étude (Réel)
1 juin 2005
Dates d'inscription aux études
Première soumission
24 août 2004
Première soumission répondant aux critères de contrôle qualité
25 août 2004
Première publication (Estimation)
26 août 2004
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
22 octobre 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 octobre 2013
Dernière vérification
1 octobre 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24979
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .