Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis
21 de outubro de 2013 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
854
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alberta
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Edmonton, Alberta, Canadá, T5J3S9
- Probity Medical Research
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Ontario
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London, Ontario, Canadá, N6A 3H7
- Guenther Dermatology Research Center
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Waterloo, Ontario, Canadá, N2J 1C4
- Probity Medical Research
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A.
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California
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Fresno, California, Estados Unidos, 93710
- Associates in Research Inc.
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Irvine, California, Estados Unidos, 92697
- University of California, Irvine
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La Jolla, California, Estados Unidos, 92037
- Therapeutics Clinical Research
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San Francisco, California, Estados Unidos, 94108
- University of California
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Santa Monica, California, Estados Unidos, 90404
- Clinical Research Specialists Inc.
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Vallejo, California, Estados Unidos, 94589
- Solano Clinical Research
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Vista, California, Estados Unidos, 92083
- Dermatology Specialists Inc
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Colorado
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Denver, Colorado, Estados Unidos, 80210
- Colorado Medical Research Center
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Denver, Colorado, Estados Unidos, 80246
- Cherry Creek Research, Inc.
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Longmont, Colorado, Estados Unidos, 80501
- Longmont Clinic PC
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- The Savin Center P.C.
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010
- Dermatology Associates, P.C. at the Washington Hospital CTR
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Florida
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Jacksonville, Florida, Estados Unidos, 32216
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Estados Unidos, 32204
- North Florida Dermatology Associates, P.A.
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Miami, Florida, Estados Unidos, 33144
- International Dermatology Research
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Georgia
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Alpharetta, Georgia, Estados Unidos, 30005
- Atlanta Dermatology Vein & Research Center
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Illinois
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Buffalo Grove, Illinois, Estados Unidos, 60089
- Scott D. Glazer, MD
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Department of Dermatology
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Clinton Township, Michigan, Estados Unidos, 48038
- Midwest Cutaneous Research Corporation
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Minnesota
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Fridley, Minnesota, Estados Unidos, 55432
- Minnesota Clinical Study Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
- Academic Dermatology Associates
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North Carolina
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Winston Salem, North Carolina, Estados Unidos, 27157
- Wake Forest Univ School of Medicine
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Winston Salem, North Carolina, Estados Unidos, 27103
- Piedmont Medical Research Associates
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Oregon
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Portland, Oregon, Estados Unidos, 97223
- Oregon Medical Research Center, P.C.
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Portland, Oregon, Estados Unidos, 97210
- Northwest Cutaneous Research Specialist
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Tennessee
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Goodlettsville, Tennessee, Estados Unidos, 37072
- Rivergate Dermatology
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Knoxville, Tennessee, Estados Unidos, 37917
- Saint Mary's Centeral Wing Annex
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Nashville, Tennessee, Estados Unidos, 37221
- Tennessee Clinical Research Center
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Texas
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Austin, Texas, Estados Unidos, 78759
- DermResearch Inc
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Dallas, Texas, Estados Unidos, 75230
- Texas Dermatology Research Institute
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Houston, Texas, Estados Unidos, 77030
- Center for Clinical Studies
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Houston, Texas, Estados Unidos, 77058
- Center for Clinical Studies
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Houston, Texas, Estados Unidos, 77030
- University Texas M.D. Anderson Cancer Center
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Virginia Clinical Research, Inc
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Dermatology Associates P.L.L.C.
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Spokane, Washington, Estados Unidos, 99202
- Rockwood Clinic, PS
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de 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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Experimental: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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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
Prazo: 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
Prazo: Week 52
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Week 52
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Percentage of subjects attaining a Physician's Global Assessment (PGA) rating of Cleared or Almost Cleared at Week 12
Prazo: Week 12
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Week 12
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and Week 12
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Baseline and Week 12
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Median time to relapse
Prazo: 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
Prazo: Week 52
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Week 52
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Mean percentage improvement in Psoriatic Area and Severity Index (PASI) Score
Prazo: 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
Prazo: 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
Prazo: Week 36 up to Week 52
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Week 36 up to Week 52
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2004
Conclusão Primária (Real)
1 de junho de 2005
Conclusão do estudo (Real)
1 de junho de 2005
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2004
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de agosto de 2004
Primeira postagem (Estimativa)
26 de agosto de 2004
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
22 de outubro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de outubro de 2013
Última verificação
1 de outubro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 24979
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .