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A Study of Baricitinib (LY3009104) in Adults With Moderate to Severe Atopic Dermatitis (BREEZE-AD1)

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ClinicalTrials.gov Identifier: NCT03334396
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : December 4, 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 efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : July 18, 2019
Estimated Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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

Drug: Placebo
Administered orally.

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




Primary Outcome Measures :
  1. Proportion of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥ 2 Point Improvement [ Time Frame: 16 Weeks ]
    Proportion of participants achieving IGA of 0 or 1 with a ≥ 2 point improvement


Secondary Outcome Measures :
  1. Proportion of Participants Achieving IGA of 0 or 1 with a ≥ 2 Point Improvement (Mid or Low Dose) [ Time Frame: 16 Weeks ]
    Proportion of participants achieving IGA of 0 or 1 with a ≥ 2 point improvement

  2. Proportion of Participants Achieving Eczema Area and Severity Index 75 (EASI75) [ Time Frame: 16 Weeks ]
    Proportion of participants achieving EASI75

  3. Proportion of Participants Achieving EASI90 [ Time Frame: 16 Weeks ]
    Proportion of participants achieving EASI90

  4. Percent Change from Baseline in EASI Score [ Time Frame: Baseline, 16 Weeks ]
    Percent change from baseline in EASI score

  5. Proportion of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) [ Time Frame: 16 Weeks ]
    Proportion of participants achieving SCORAD75

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

  7. Change from Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the score of item #2 of the ADSS

  8. Change from Baseline in the Skin Pain NRS [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the skin pain NRS

  9. Proportion of Participants Achieving EASI50 [ Time Frame: 16 Weeks ]
    Proportion of participants achieving EASI50

  10. Proportion of Participants Achieving IGA of 0 [ Time Frame: 16 Weeks ]
    Proportion of participants achieving IGA of 0

  11. Change from Baseline in SCORAD [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in SCORAD

  12. Proportion of Participants Achieving SCORAD90 [ Time Frame: 16 Weeks ]
    Proportion of participants achieving SCORAD90

  13. Change from Baseline in Body Surface Area (BSA) Affected [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in BSA affected

  14. Proportion of Participants Developing Skin Infections Requiring Antibiotic Treatment [ Time Frame: 16 Weeks ]
    Proportion of participants developing skin infections requiring antibiotic treatment

  15. Percent Change from Baseline in Itch NRS [ Time Frame: Baseline, 16 Weeks ]
    Percent change from baseline in Itch NRS

  16. Change from Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the total score of the POEM

  17. Change from Baseline in the Patient Global Impression of Severity—Atopic Dermatitis (PGI-S-AD) Score [ Time Frame: Baseline, 16 Weeks ]
    Change from Baseline in the PGI-S-AD

  18. Change from Baseline on the Hospital Anxiety Depression Scale (HADS) [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline on the HADS

  19. Change from Baseline in the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline on the DLQI

  20. Change from Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline on the WPAI-AD questionnaire

  21. Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline on the EQ-5D-5L



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 diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
  • Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
  • Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
  • Agree to use emollients daily.

Exclusion Criteria:

  • Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
  • A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
  • Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
  • Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
  • Have been treated with the following therapies:

    • Monoclonal antibody for less than 5 half-lives prior to randomization.
    • Received prior treatment with any oral Janus kinase (JAK) inhibitor.
    • Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
    • Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
  • Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
  • Have had major surgery within the past eight weeks or are planning major surgery during the study.
  • Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
  • Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
  • Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
  • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
  • Have specific laboratory abnormalities.
  • Have received certain treatments that are contraindicated.
  • 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): NCT03334396


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 93 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: NCT03334396     History of Changes
Other Study ID Numbers: 16580
I4V-MC-JAHL ( Other Identifier: Eli Lilly and Company )
2017-000870-12 ( EudraCT Number )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 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