A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
31 de março de 2015 atualizado por: Centocor, Inc.
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 (Human Monoclonal Antibody to IL-12) in Subjects With Moderate to Severe Psoriasis
The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis).
The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses.
Patients who inadequately respond to their treatment may receive one additional dose.
Patients will be monitored for the safety throughout the study.
Tipo de estudo
Intervencional
Inscrição (Real)
320
Estágio
- Fase 2
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:
- Have had a diagnosis of plaque-type psoriasis at least 6 months
- Plaque-type psoriasis covering at least 10% of total body surface areas
- Psoriasis area-and-severity index score of 12 or greater
- Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
- Women of childbearing potential and all men must agree to use adequate birth control measures
- Have no history of latent or active tuberculosis
Exclusion Criteria:
- Currently have nonplaque forms of psoriasis or drug-induced psoriasis
- Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
- Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months
- Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
- Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
- Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
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 |
|---|---|
|
Comparador de Placebo: Group I (Placebo)
Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16.
At week 20, all patients will receive a single dose of ustekinumab 90 mg.
|
Patients in the placebo group will receive placebo medication.
|
|
Experimental: Group II (Ustekinumab 45 mg)
Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3.
At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg.
At week 20, all patients will receive placebo.
|
Patients in the placebo group will receive placebo medication.
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Outros nomes:
|
|
Experimental: Group III (Ustekinumab 90 mg)
Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3.
At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg.
At week 20, all patients will receive placebo.
|
Patients in the placebo group will receive placebo medication.
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Outros nomes:
|
|
Experimental: Group IV
Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3.
At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg.
At week 20, all patients will receive placebo.
|
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Outros nomes:
|
|
Experimental: Group V
Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3.
At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg.
At week 20, all patients will receive placebo.
|
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
Prazo: Week 12
|
Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12.
This is a test of how bad a person's psoriasis is.
The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
|
Week 12
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
Prazo: Week 12
|
Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12.
The PGA is used to determine the participants psoriasis lesions overall at a given time point.
Overall lesions will be graded for induration, erythema, and scaling.
The sum of the 3 scales will be divided by 3 to obtain a final PGA score.
|
Week 12
|
|
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32
Prazo: Week 32
|
Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16.
This is a test of how bad a person's psoriasis is.
The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
|
Week 32
|
|
Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28
Prazo: Week 28
|
Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16.
This is a test of how bad a person's psoriasis is.
The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
|
Week 28
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:
- Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M; CNTO 1275 Psoriasis Study Group. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007 Feb 8;356(6):580-92. doi: 10.1056/NEJMoa062382.
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 novembro de 2003
Conclusão Primária (Real)
1 de junho de 2004
Conclusão do estudo (Real)
1 de março de 2005
Datas de inscrição no estudo
Enviado pela primeira vez
28 de abril de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de abril de 2006
Primeira postagem (Estimativa)
3 de maio de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
20 de abril de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de março de 2015
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR005416
- C0379T04 (Outro identificador: Centocor)
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 .