Study Stopped
The study was terminated for lack of efficacy after an interim analysis was performed
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
3 other identifiers
interventional
136
13 countries
58
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2019
Shorter than P25 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedStudy Start
First participant enrolled
February 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2020
CompletedResults Posted
Study results publicly available
April 20, 2021
CompletedApril 20, 2021
June 1, 2020
1 year
February 4, 2019
February 12, 2021
March 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
Week 16
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
Week 16
Percentage of Participants Achieving vIGA-AD of 0
Week 16
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
Baseline, Week 16
Mean Change From Baseline in SCORAD
Baseline, Week 16
- +2 more secondary outcomes
Study Arms (4)
50 mg LY3375880
EXPERIMENTALInduction Period: Participants received 50 mg LY3375880 administered SC Q4W.
150 mg LY3375880
EXPERIMENTALInduction Period: Participants received 150 mg LY3375880 administered SC Q4W.
600 mg LY3375880
EXPERIMENTALInduction Period: Participants received 600 mg LY3375880 administered SC Q4W.
Placebo
PLACEBO COMPARATORInduction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Participants must not have concurrent treatment with topical or systemic treatments for AD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, 92708, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Quest Dermatology Research
Northridge, California, 91324, United States
Integrative Skin Science and Research
Sacramento, California, 95815, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, 20850, United States
ActivMed Practices & Research, Inc
Portsmouth, New Hampshire, 03801, United States
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, 28277, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28411, United States
Hightower Clinical Trial Services
Norman, Oklahoma, 73072, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
DOM- Centro de Reumatologia
CABA, Buenos Aires, 1111, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1027AAP, Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, C1055AA0, Argentina
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires, C1425BEA, Argentina
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires, C1425DKG, Argentina
Parra Dermatología
Mendoza, 5500, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, T4000AXL, Argentina
Universitätsklinikum Graz
Graz, Styria, 8036, Austria
LKH Feldkirch
Feldkirch, Vorarlberg, 6807, Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna, 1220, Austria
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
Clintrial, s.r.o.
Prague, Hl. M. Praha, 100 00, Czechia
Sanatorium Profesora Arenbergera
Prague, 110 00, Czechia
CHU de Nice Hopital de L'Archet
Nice, 06202, France
Dermatologikum Hamburg
Hamburg, 20354, Germany
TFS Trial Form Support GmbH
Hamburg, 20537, Germany
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, Bekes County, 5900-H, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
UNO Medical Trials Kft.
Budapest, 1135, Hungary
MedMare Bt
Veszprém, 8200, Hungary
Policlinico di Tor Vergata
Rome, Lazio, 00133, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Polic.Umberto I -Univ. La Sapienza
Roma, 00161, Italy
Yasumoto Dermatology Clinic
Chikushino-shi, Fukuoka, 818 0083, Japan
Takagi Dermatological Clinic
Obihiro, Hokkaido, 080-0013, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Meiwa Hospital
Nishinomiya, Hyōgo, 663-8186, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, 8795593, Japan
Kume Clinic
Nishi-ku Sakai-shi, Osaka, 593-8324, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 343 8555, Japan
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, 133-0057, Japan
Matsuda Tomoko Dematological Clinic
Fukuoka, 819 0167, Japan
Grupo Medico Camino S.C.
Mexico City, Mexico City, 03310, Mexico
Derma Norte del Bajío, S.C.
Aguascalientes, Mexico
Office of Dr. Samuel Sanchez PSC
Caguas, PR, 00727, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, PR, 00985, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716, Puerto Rico
GCM Medical Group PSC
San Juan, PR, 00917, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, 31008, Spain
Clinica Universidad De Navarra
Madrid, 28027, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated for lack of efficacy after an interim analysis was performed.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2019
First Posted
February 5, 2019
Study Start
February 12, 2019
Primary Completion
February 27, 2020
Study Completion
February 27, 2020
Last Updated
April 20, 2021
Results First Posted
April 20, 2021
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.