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A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis (ADmIRe)

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: NCT03831191
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if the study drug LY3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LY3375880 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis: The ADmIRe Study
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : February 14, 2020
Estimated Study Completion Date : February 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: LY3375880 Dose 1
LY3375880 administered subcutaneously (SC).
Drug: LY3375880
Administered SC

Experimental: LY3375880 Dose 2
LY3375880 administered SC.
Drug: LY3375880
Administered SC

Experimental: LY3375880 Dose 3
LY3375880 administered SC.
Drug: LY3375880
Administered SC

Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC




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


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

  2. Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75) [ Time Frame: 16 Weeks ]
    Percentage of Participants Achieving (SCORAD-75)

  3. Percentage of Participants Achieving IGA of 0 [ Time Frame: 16 Weeks ]
    Percentage of Participants Achieving IGA of 0

  4. Mean Change from Baseline in Eczema Area and Severity Index (EASI) Score [ Time Frame: Baseline, 16 Weeks ]
    Mean Change from Baseline in EASI Score

  5. Mean Change from Baseline in SCORAD [ Time Frame: Baseline, 16 Weeks ]
    Mean Change from Baseline in SCORAD

  6. Percentage of Participants Achieving IGA of 0 or 1 [ Time Frame: 52 Weeks ]
    Percentage of Participants Achieving IGA of 0 or 1

  7. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880 [ Time Frame: Pre-dose to Follow-Up (Approximately 60 Weeks) ]
    PK: AUC of LY3375880



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:

  • Participants must have diagnosis of AD >= 12 months according to the American Academy of Dermatology criteria.
  • Participants must have moderate to severe AD at screening and randomization.
  • Participants must have inadequate response to topical medications within 6 months of screening (or history of intolerance).

Exclusion Criteria:

  • Participants must not have concurrent treatment with topical or systemic treatments for AD.

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): NCT03831191


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 64 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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: NCT03831191     History of Changes
Other Study ID Numbers: 17104
I9N-MC-FCAB ( Other Identifier: Eli Lilly and Company )
2018-002401-56 ( EudraCT Number )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 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
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