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Trial record 6 of 62 for:    Baricitinib

A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis (BREEZE-AD6)

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ClinicalTrials.gov Identifier: NCT03559270
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2018
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD), who have completed participation in study BREEZE-AD5/Study JAIW (NCT03435081). This 204-week outpatient study, includes a treatment period of approximately 200-weeks and up to 17 planned study visits.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Baricitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : November 25, 2021
Estimated Study Completion Date : December 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Baricitinib
Baricitinib administered orally.
Drug: Baricitinib
Administered orally
Other Name: LY3009104




Primary Outcome Measures :
  1. Proportion of Participants Achieving Eczema Area and Severity Index (EASI75) [ Time Frame: Week 16 ]
    Proportion of participants achieving EASI75


Secondary Outcome Measures :
  1. Proportion of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 [ Time Frame: Week 16 ]
    Proportion of participants achieving IGA of 0 or 1

  2. Proportion of Participants Achieving a Body Surface Area of ≤3% [ Time Frame: Week 16 ]
    Proportion of participants achieving a body surface area of ≤3%

  3. Proportion of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS) [ Time Frame: Week 16 ]
    Proportion of participants achieving a ≥4-point improvement in itch NRS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been discontinued from study JAIW, and completed at least 16 weeks on treatment.

Exclusion Criteria:

  • Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
  • Have a known hypersensitivity to baricitinib or any component of this investigational product.
  • Had investigational product permanently discontinued at any time during a previous baricitinib study, except for participants who had investigational product discontinued during originating study because of rescue with an oral systemic AD therapy (e.g., corticosteroid, cyclosporine, methotrexate).
  • Had temporary investigational product interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study.
  • Pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559270


  Show 75 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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Study Director: 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03559270     History of Changes
Other Study ID Numbers: 17064
I4V-MC-JAIX ( Other Identifier: Eli Lilly and Company )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
eczema
atopic eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases