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

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

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).

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: LY3375880

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1027AAP
    • Centro de Investigaciones Metabólicas (CINME)
  • Ciudad Autonoma Buenos Aires, Argentina, C1055AA0
    • Buenos Aires Skin
  • Ciudad Autonoma Buenos Aires, Argentina, C1425BEA
    • Instituto de Neumonologia y Dermatologia
  • Ciudad Autonoma Buenos Aires, Argentina, C1425DKG
    • Psoriahue Medicina Interdisciplinaria
  • Mendoza, Argentina, 5500
    • Parra Dermatología
  • Tucuman, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1111
      • DOM- Centro de Reumatologia
• Austria
  • Wien, Austria, 1220
    • Sozialmed. Zentrum Ost - Donauspital
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Universitätsklinikum Graz
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6807
      • LKH Feldkirch
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre
• Czechia
  • Praha 1, Czechia, 110 00
    • Sanatorium Profesora Arenbergera
  • Hl. M. Praha
    • Praha 10, Hl. M. Praha, Czechia, 100 00
      • CLINTRIAL, s.r.o.
• France
  • Nice cedex 3, France, 06202
    • CHU De Nice Hopital De l'Archet
• Germany
  • Hamburg, Germany, 20354
    • Dermatologikum Hamburg
  • Hamburg, Germany, 20537
    • TFS Trial Form Support GmbH
• Hungary
  • Budapest, Hungary, 1135
    • UNO Medical Trials Kft.
  • Veszprem, Hungary, 8200
    • Medmare Bt
  • Bekes
    • Oroshaza, Bekes, Hungary, 5900-H
      • Oroshaza Varosi Onkormanyzat Korhaza
  • Jasz-Nagykun-Szolnok
    • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
      • Allergo-Derm Bakos Kft
• Italy
  • Roma, Italy, 00161
    • Polic.Umberto I -Univ. La Sapienza
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Policlinico Di Tor Vergata
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
• Japan
  • Fukuoka, Japan, 819 0167
    • Matsuda Tomoko Dematological Clinic
  • Fukuoka
    • Chikushino, Fukuoka, Japan, 818 0083
      • Yasumoto Dermatology Clinic
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Hospital
    • Nishinomiya, Hyogo, Japan, 663-8186
      • Meiwa Hospital
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 602-8566
      • Kyoto Prefectural University of Medicine
  • Oita
    • Yufu-shi, Oita, Japan, 8795593
      • Oita University Hospital
  • Osaka
    • Nishi-ku Sakai-shi, Osaka, Japan, 593-8324
      • Kume Clinic
  • Saitama
    • Koshigaya, Saitama, Japan, 343 8555
      • Dokkyo Medical University Saitama Medical Center
  • Tokyo
    • Edogawa-ku, Tokyo, Japan, 133-0057
      • Sumire Dermatology Clinic
• Mexico
  • Aguascalientes, Mexico
    • Derma Norte del Bajío, S.C.
  • Distrito Federal
    • México City, Distrito Federal, Mexico, 03310
      • Grupo Medico Camino S.C.
• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Office of Dr. Samuel Sanchez PSC
  • Carolina, Puerto Rico, 00985
    • Office of Dr. Alma M. Cruz
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine CAIMED Center
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico, Inc.
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group PSC
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Tien Q. Nguyen, MD inc. DBA First OC Dermatology
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Northridge, California, United States, 91324
      • Quest Dermatology Research
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
  • Indiana
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermatology and Skin Cancer Specialists
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research, Inc
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Piedmont Plastic Surgery and Dermatology
    • Wilmington, North Carolina, United States, 28411
      • PMG Research of Wilmington, LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Hightower Clinical Trial Services
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners LLC
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement	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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)	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.	Week 16
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)	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.	Week 16
Percentage of Participants Achieving vIGA-AD of 0	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.	Week 16
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score	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.	Baseline, Week 16
Mean Change From Baseline in SCORAD	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.	Baseline, Week 16
Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at 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.	Week 52
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880	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).	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): February 27, 2020

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: eczema; atopic eczema
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 17104; I9N-MC-FCAB (Other Identifier: Eli Lilly and Company); 2018-002401-56 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No