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Trial record 13 of 62 for:    Baricitinib

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis (BREEZE-AD-PEDS)

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ClinicalTrials.gov Identifier: NCT03952559
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : January 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Baricitinib Open Label High Dose
Baricitinib administered orally.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

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

Drug: Topical corticosteroid
Administered as standard-of-care

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

Drug: Topical corticosteroid
Administered as standard-of-care

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

Drug: Topical corticosteroid
Administered as standard-of-care

Placebo Comparator: Placebo
Placebo administered orally. Matching placebo administered orally to maintain the blind.
Drug: Placebo
Administered orally

Drug: Topical corticosteroid
Administered as standard-of-care




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

  2. Open Label Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009104 [ Time Frame: Baseline through 2 Weeks ]
    PK: Cmax of LY3009104

  3. Open Label PK: Area Under the Concentration Time Curve (AUC) of LY3009104 [ Time Frame: Baseline through 2 Weeks ]
    PK: AUC of LY3009104


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) [ Time Frame: 16 Weeks ]
    Percentage of participants achieving EASI75

  2. Percentage of Participants Achieving EASI90 [ Time Frame: 16 Weeks ]
    Percentage of participants achieving EASI90

  3. Change from Baseline on EASI Score [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline on EASI Score

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

  5. Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants ≥10 Years Old [ Time Frame: 16 Weeks ]
    Percentage of participants achieving a 4-point improvement in Itch NRS for participants ≥10 years old

  6. Percentage of Participants Achieving EASI50 [ Time Frame: 16 Weeks ]
    Percentage of participants achieving EASI50

  7. Percentage of Participants Achieving IGA of 0 [ Time Frame: 16 Weeks ]
    Percentage of participants achieving IGA of 0

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

  9. Percentage of Participants Achieving SCORAD90 [ Time Frame: 16 Weeks ]
    Percentage of participants achieving SCORAD90

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

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

  12. Mean Number of Days without Use of Background Topical Corticosteroid (TCS) [ Time Frame: Baseline through 16 Weeks ]
    Mean number of days without use of background TCS

  13. Mean Gram Quantity of TCS Use (Tube Weights) [ Time Frame: Baseline through 16 Weeks ]
    Mean gram quantity of TCS use (tube weights)

  14. Change from Baseline in Itch NRS [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in itch NRS

  15. Change from Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants <10 years old [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the PRISM for participants <10 years old

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

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

  18. Change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pediatric Depression [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the PROMIS-pediatric depression

  19. Change from Baseline in the PROMIS-Pediatric Anxiety [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the PROMIS-pediatric anxiety

  20. Change from Baseline in the Children's/Infants's Dermatology Life Quality Index (CDLQI/IDQOL) [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the CDLQI/IDQOL

  21. Change from Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline on the WPAI-AD-CG score

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

  23. Change from Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants ≥10 Years Old [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in the score of item 2 of the ADSS for participants ≥10 years old

  24. Change from Baseline in Skin Pain NRS for Participants ≥10 Years Old [ Time Frame: Baseline, 16 Weeks ]
    Change from baseline in Skin Pain NRS for participants ≥10 years old

  25. Acceptability Assessment (PK Lead-In) [ Time Frame: 2 Weeks ]
    Participants were evaluated for baricitinib acceptability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the ease of use of baricitinib: Very difficult (or hard), difficult (or hard), neither easy nor hard, easy, or very easy.

  26. Palatability Assessment (PK Lead-In) [ Time Frame: 2 Weeks ]
    Participants were evaluated for baricitinib palatability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the taste and smell of baricitinib: Disliked very much, disliked, neither liked nor disliked, liked, or like very much.

  27. Change of Immunoglobulin G (IgG) Titers [ Time Frame: Pre-Vaccination to 12 Weeks Post-Vaccination ]
    Change of IgG titers

  28. Height Growth Rate (in Centimeters/Year) [ Time Frame: 124 Weeks ]
    Height growth rate (in centimeters/year)

  29. PK: Cmax of LY3009104 [ Time Frame: Baseline through 16 Weeks ]
    PK: Cmax of LY3009104

  30. PK: AUC of LY3009104 [ Time Frame: Baseline through 16 Weeks ]
    PK: AUC of LY3009104



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At or above the 5th percentile of weight for age.
  • Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).
  • 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 beginning study treatment.
    • 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 initiation of study drug 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 initiation of study drug.
  • Have high blood pressure characterized by a repeated systolic or diastolic blood pressure >95th percentile based on age, sex and height.
  • 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 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 (shingles or chicken pox), 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): NCT03952559


Contacts
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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 90 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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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:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03952559     History of Changes
Other Study ID Numbers: 16966
I4V-MC-JAIP ( Other Identifier: Eli Lilly and Company )
2018-000349-38 ( EudraCT Number )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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