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A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (BREEZE-AD3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334435
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE March 28, 2018
Estimated Primary Completion Date September 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Proportion of Participants with a Response of Investigator's Global Assessment (IGA) 0 or 1 at 16 Weeks [ Time Frame: 16 Weeks ]
    Proportion of participants achieving IGA 0 or 1 at 16 weeks
  • Proportion of Participants with a Response of IGA 0 or 1 at 36 Weeks [ Time Frame: 36 Weeks ]
    Proportion of participants achieving IGA 0 or 1 at 36 weeks
  • Proportion of Participants with a Response of IGA 0 or 1 at 52 Weeks [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0 or 1 at 52 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03334435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Proportion of Participants Achieving IGA 0, 1 or 2 [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0,1 or 2
  • Proportion of Participants Achieving IGA 0 or 1 (non-responders) [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0 or 1
  • Proportion of Participants Achieving Response of Eczema Area and Severity Index (EASI)75 from Baseline of Originating Study [ Time Frame: 52 Weeks ]
    Proportion of participants achieving response of EASI75 from baseline of originating study
  • Proportion of Participants with a 4-Point Improvement from Baseline of Originating Study in Itch NRS [ Time Frame: 16 Weeks ]
    Proportion of participants with a 4 point improvement from baseline of originating study in Itch NRS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
Official Title  ICMJE A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
Brief Summary The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally
    Other Name: LY3009104
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: Baricitinib High Dose Nonresponders
    Baricitinib administered orally. Placebo administered orally to maintain the blind.
    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
  • Experimental: Baricitinib High Dose Nonresponders Rescued
    Baricitinib administered orally. Placebo administered orally to maintain the blind.
    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
  • Experimental: Baricitinib Mid Dose Nonresponders Rescued
    Baricitinib administered orally. Placebo administered orally to maintain the blind.
    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
  • Experimental: Baricitinib High Dose Responders
    Baricitinib administered orally. Placebo administered orally to maintain the blind.
    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
  • Experimental: Baricitinib Mid Dose Responders
    Baricitinib administered orally. Placebo administered orally to maintain the blind.
    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
  • Experimental: Baricitinib Low Dose Responders
    Baricitinib administered orally. Placebo administered orally to maintain the blind.
    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
  • Placebo Comparator: Placebo Responders
    Placebo administered orally.
    Intervention: Drug: Placebo
  • Experimental: Baricitinib Open Label Extension
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2019)
1760
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
1170
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have completed the final active treatment visit for an originating study eligible to enroll participants directly into study BREEZE-AD3 OR
  • Meet criteria for NCT03334396 or NCT03334422.

Exclusion Criteria:

  • Had investigational product permanently discontinued at any time during a previous baricitinib study.
  • 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.
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: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Czechia,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Spain,   Switzerland,   Taiwan
Removed Location Countries Canada,   Ireland,   Swaziland
 
Administrative Information
NCT Number  ICMJE NCT03334435
Other Study ID Numbers  ICMJE 16587
I4V-MC-JAHN ( Other Identifier: Eli Lilly and Company )
2017-000873-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
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: Call 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 January 1, 2020

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