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

10 juin 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

124

Phase

  • Phase 2

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

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

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:

  • 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 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
Expérimental: Baricitinib

Administered once daily in multiple oral dose cohorts for 16 weeks

(Triamcinolone 0.1% topical also permitted)
Médicament: Baricitinib
Administré par voie orale
Autres noms:
  • LY3009104
  • OICS028050
Médicament: Triamcinolone (Optional)
Administered topically
Comparateur placebo: Placebo

Administered orally once daily, for 16 weeks

(Triamcinolone 0.1% topical also permitted)
Médicament: Placebo
Administré par voie orale
Médicament: Triamcinolone (Optional)
Administered topically

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in the EASI at Week 16
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

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.

Publications générales

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 février 2016

Achèvement primaire (Réel)

1 février 2017

Achèvement de l'étude (Réel)

1 mars 2017

Dates d'inscription aux études

Première soumission

14 octobre 2015

Première soumission répondant aux critères de contrôle qualité

14 octobre 2015

Première publication (Estimation)

15 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2020

Dernière vérification

1 juin 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 16284
  • I4V-MC-JAHG (Autre identifiant: Eli Lilly and Company)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage 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

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

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 .

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