A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
10 de junho de 2020 atualizado por: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Baricitinib in Patients With Moderate-to-Severe Atopic Dermatitis
The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
124
Estágio
- Fase 2
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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California
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Los Angeles, California, Estados Unidos, 90045
- Dermatology Research Associates
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Florida
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Tampa, Florida, Estados Unidos, 33624
- Forward Clinical Trials, Inc
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Medical Dermatology Specialists
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Menter Dermatology Research Institute
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Houston, Texas, Estados Unidos, 77004
- Center for Clinical Studies
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Houston, Texas, Estados Unidos, 77065
- Center for Clinical Studies
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Webster, Texas, Estados Unidos, 77598
- Center for Clinical Studies
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Fukuoka-shi, Japão, 815-0082
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sapporo, Japão, 060-0063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Takaoka-shi, Japão, 933-0871
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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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:
Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:
- EASI of 12 or more
- Greater than or equal to 10% of body surface area involvement
- Diagnosed with AD at least 2 years prior
- Have a history of inadequate clinical response to other eczema treatments
Exclusion Criteria:
- Females who are pregnant or nursing
- Participants who do not agree to use adequate contraception
Are currently experiencing or have a history of:
- Skin conditions such as psoriasis or lupus erythematosus
- Skin disease that requires frequent hospitalizations or intravenous treatment
- Compromised immunity
- Serious illness that could interfere with study participation, or a clinically important deviation in physical examination, vital sign measurements, electrocardiograms, or abnormalities on laboratory tests
Currently experiencing or have a history of:
- Active or latent Tuberculosis or specific immunity disorders and infections
- Malignancy or lymphoproliferative diseases in the last 5 years (or cervical, basal or squamous skin cancer re-occurrence in the last 3 years)
- Human Immunodeficiency Virus (HIV)
- Hepatitis B, Hepatitis C, or chronic liver disease
- Have received certain types of vaccinations
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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Experimental: Baricitinib
Administered once daily in multiple oral dose cohorts for 16 weeks (Triamcinolone 0.1% topical also permitted) |
Administrado por via oral
Outros nomes:
Administered topically
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Comparador de Placebo: Placebo
Administered orally once daily, for 16 weeks (Triamcinolone 0.1% topical also permitted) |
Administrado por via oral
Administered topically
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
Prazo: Week 16
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The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
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Week 16
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in the EASI at Week 16
Prazo: Baseline, Week 16
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The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
Change from baseline were analyzed with a Mixed-effect Model Repeated Measure (MMRM) with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
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Baseline, Week 16
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Percentage Change From Baseline in the EASI at Week 16
Prazo: Baseline, Week 16
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The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.
Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
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Baseline, Week 16
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Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16
Prazo: Baseline, Week 16
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The SCORAD index uses the rule of nines to assess disease extent and evaluates five clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation and (5) lichenification.
SCORAD also assesses subjective symptoms of pruritus and sleep loss with Visual Analogue Scales (VAS) where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness).
These three aspects: extent of disease (A: 0-102), disease severity (B: 0-18) and subjective symptoms (C:0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103 where 0 = no disease and 103 = severe disease.
Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.
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Baseline, Week 16
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Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16
Prazo: Baseline, Week 16
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The IGA consists of a 6-point severity scale to measure characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment.
The scale ranges from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease).
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Baseline, Week 16
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Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16
Prazo: Baseline, Week 16
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The DLQI is a simple, participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively.
Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0".
For all questions, if unanswered the question is scored as "0".
Totals range from 0 to 30 (less to more impairment).
Changes from baseline in DLQI score were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.
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Baseline, Week 16
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Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16
Prazo: Baseline, Week 16
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The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable."
Overall severity of a participant's itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Changes from baseline were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.
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Baseline, Week 16
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Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib
Prazo: Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.
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Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib
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Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.
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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
- King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
- Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
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 fevereiro de 2016
Conclusão Primária (Real)
1 de fevereiro de 2017
Conclusão do estudo (Real)
1 de março de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
14 de outubro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de outubro de 2015
Primeira postagem (Estimativa)
15 de outubro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de junho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de junho de 2020
Última verificação
1 de junho de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças de pele
- Doenças do sistema imunológico
- Hipersensibilidade, Imediata
- Doenças Genéticas, Congênitas
- Doenças de Pele Genéticas
- Hipersensibilidade
- Doenças de Pele, Eczematosas
- Dermatite
- Eczema
- Dermatite Atópica
- Efeitos Fisiológicos das Drogas
- Antiinflamatórios
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Triancinolona
Outros números de identificação do estudo
- 16284
- I4V-MC-JAHG (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Prazo de Compartilhamento de IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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 .