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

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ClinicalTrials.gov Identifier: NCT03831191
Recruitment Status : Terminated (The study was terminated for lack of efficacy after an interim analysis was performed)
First Posted : February 5, 2019
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
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)
Actual Enrollment : 136 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
Actual Primary Completion Date : February 27, 2020
Actual Study Completion Date : February 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 50 mg LY3375880

Induction Period:

Participants received 50 mg LY3375880 administered SC Q4W.

Drug: LY3375880
Administered SC

Experimental: 150 mg LY3375880

Induction Period:

Participants received 150 mg LY3375880 administered SC Q4W.

Drug: LY3375880
Administered SC

Experimental: 600 mg LY3375880

Induction Period:

Participants received 600 mg LY3375880 administered SC Q4W.

Drug: LY3375880
Administered SC

Placebo Comparator: Placebo

Induction Period:

Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement [ Time Frame: Week 16 ]
    vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) [ Time Frame: Week 16 ]
    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.

  2. Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75) [ Time Frame: Week 16 ]
    The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.

  3. Percentage of Participants Achieving vIGA-AD of 0 [ Time Frame: Week 16 ]
    vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.

  4. Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score [ Time Frame: Baseline, Week 16 ]
    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.

  5. Mean Change From Baseline in SCORAD [ Time Frame: Baseline, Week 16 ]
    The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.

  6. Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52 [ Time Frame: Week 52 ]
    vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.

  7. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880 [ Time Frame: Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose ]
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).



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


Locations
Show Show 58 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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] July 25, 2019
Statistical Analysis Plan  [PDF] November 27, 2019

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03831191    
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
Results First Posted: April 20, 2021
Last Update Posted: April 20, 2021
Last Verified: June 2020
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