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A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis

10 de junio de 2020 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

124

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90045
        • Dermatology Research Associates
    • Florida
      • Tampa, Florida, Estados Unidos, 33624
        • Forward Clinical Trials, Inc
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Medical Dermatology Specialists
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
    • New York
      • New York, New York, Estados Unidos, 10029
        • Icahn School of Medicine
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Menter Dermatology Research Institute
      • Houston, Texas, Estados Unidos, 77004
        • Center for Clinical Studies
      • Houston, Texas, Estados Unidos, 77065
        • Center for Clinical Studies
      • Webster, Texas, Estados Unidos, 77598
        • Center for Clinical Studies
  • Japón
      • Fukuoka-shi, Japón, 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.
      • Sapporo, Japón, 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.
      • Takaoka-shi, Japón, 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

    1. EASI of 12 or more
    2. Greater than or equal to 10% of body surface area involvement
    3. 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Baricitinib

Administered once daily in multiple oral dose cohorts for 16 weeks

(Triamcinolone 0.1% topical also permitted)
Droga: Baricitinib
Administrado por vía oral
Otros nombres:
  • LY3009104
  • INCB028050
Droga: Triamcinolone (Optional)
Administered topically
Comparador de placebos: Placebo

Administered orally once daily, for 16 weeks

(Triamcinolone 0.1% topical also permitted)
Droga: Placebo
Administrado por vía oral
Droga: Triamcinolone (Optional)
Administered topically

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
Periodo de tiempo: Week 16
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.
Week 16

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in the EASI at Week 16
Periodo de tiempo: Baseline, Week 16
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.
Baseline, Week 16
Percentage Change From Baseline in the EASI at Week 16
Periodo de tiempo: Baseline, Week 16
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.
Baseline, Week 16
Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16
Periodo de tiempo: Baseline, Week 16
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.
Baseline, Week 16
Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16
Periodo de tiempo: Baseline, Week 16
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).
Baseline, Week 16
Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16
Periodo de tiempo: Baseline, Week 16
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.
Baseline, Week 16
Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16
Periodo de tiempo: Baseline, Week 16
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.
Baseline, Week 16
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib
Periodo de tiempo: 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.
Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib
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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2016

Finalización primaria (Actual)

1 de febrero de 2017

Finalización del estudio (Actual)

1 de marzo de 2017

Fechas de registro del estudio

Enviado por primera vez

14 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

14 de octubre de 2015

Publicado por primera vez (Estimar)

15 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 16284
  • I4V-MC-JAHG (Otro identificador: Eli Lilly and Company)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir 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

Criterios de acceso compartido de IPD

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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