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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

Tracking Information
First Submitted Date  ICMJE June 6, 2018
First Posted Date  ICMJE June 18, 2018
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE June 27, 2018
Estimated Primary Completion Date November 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
Proportion of Participants Achieving Eczema Area and Severity Index (EASI75) [ Time Frame: Week 16 ]
Proportion of participants achieving EASI75
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
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
Change History Complete list of historical versions of study NCT03559270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • 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
  • Proportion of Participants Achieving a Body Surface Area of ≤3% [ Time Frame: Week 16 ]
    Proportion of participants achieving a body surface area of ≤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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • Proportion of Participants Achieving Eczema Area and Severity Index (EASI75) [ Time Frame: Week 16 ]
    Proportion of participants achieving EASI75
  • Proportion of Participants Achieving a Body Surface Area of ≤3% [ Time Frame: Week 16 ]
    Proportion of participants achieving a body surface area of ≤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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Drug: Baricitinib
Administered orally
Other Name: LY3009104
Study Arms  ICMJE Experimental: Baricitinib
Baricitinib administered orally.
Intervention: Drug: Baricitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 27, 2021
Estimated Primary Completion Date November 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03559270
Other Study ID Numbers  ICMJE 17064
I4V-MC-JAIX ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Incyte Corporation
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 15, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP