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

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ClinicalTrials.gov Identifier: NCT03334435
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : December 21, 2020
Estimated Study Completion Date : January 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Baricitinib High Dose Nonresponders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib High Dose Nonresponders Rescued
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib Mid Dose Nonresponders Rescued
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib High Dose Responders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib Mid Dose Responders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Experimental: Baricitinib Low Dose Responders
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Drug: Placebo
Administered orally

Placebo Comparator: Placebo Responders
Placebo administered orally.
Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Proportion of Participants Achieving IGA 0, 1 or 2 [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0,1 or 2

  2. Proportion of Participants Achieving IGA 0 or 1 (non-responders) [ Time Frame: 52 Weeks ]
    Proportion of participants achieving IGA 0 or 1

  3. 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

  4. 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



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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 completed the final active treatment visit for an originating study eligible to enroll participants directly into study BREEZE-AD3.

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.

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): NCT03334435


Contacts
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

  Show 179 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03334435     History of Changes
Other Study ID Numbers: 16587
I4V-MC-JAHN ( Other Identifier: Eli Lilly and Company )
2017-000873-35 ( EudraCT Number )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
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.


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:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases