A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT03831191
Last Updated: 2021-04-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
136 participants
INTERVENTIONAL
2019-02-12
2020-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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50 mg LY3375880
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
LY3375880
Administered SC
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
LY3375880
Administered SC
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
LY3375880
Administered SC
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
Placebo
Administered SC
Interventions
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LY3375880
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Quest Dermatology Research
Northridge, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
The South Bend Clinic
South Bend, Indiana, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, United States
ActivMed Practices & Research, Inc
Portsmouth, New Hampshire, United States
Piedmont Plastic Surgery and Dermatology
Charlotte, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Hightower Clinical Trial Services
Norman, Oklahoma, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Center for Clinical Studies
Houston, Texas, United States
DOM- Centro de Reumatologia
CABA, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires, , Argentina
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires, , Argentina
Parra Dermatología
Mendoza, , Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, , Argentina
Universitätsklinikum Graz
Graz, Styria, Austria
LKH Feldkirch
Feldkirch, Vorarlberg, Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna, , Austria
The Guenther Dermatology Research Centre
London, Ontario, Canada
Clintrial, s.r.o.
Prague, Hl. M. Praha, Czechia
Sanatorium Profesora Arenbergera
Prague, , Czechia
CHU de Nice Hopital de L'Archet
Nice, , France
Dermatologikum Hamburg
Hamburg, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, Bekes County, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, Hungary
UNO Medical Trials Kft.
Budapest, , Hungary
MedMare Bt
Veszprém, , Hungary
Policlinico di Tor Vergata
Rome, Lazio, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Polic.Umberto I -Univ. La Sapienza
Roma, , Italy
Yasumoto Dermatology Clinic
Chikushino-shi, Fukuoka, Japan
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Meiwa Hospital
Nishinomiya, Hyōgo, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, Japan
Kume Clinic
Nishi-ku Sakai-shi, Osaka, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, Japan
Sumire Dermatology Clinic
Edogawa-ku, Tokyo, Japan
Matsuda Tomoko Dematological Clinic
Fukuoka, , Japan
Grupo Medico Camino S.C.
Mexico City, Mexico City, Mexico
Derma Norte del Bajío, S.C.
Aguascalientes, , Mexico
Office of Dr. Samuel Sanchez PSC
Caguas, PR, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, PR, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, , Puerto Rico
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, Spain
Clinica Universidad De Navarra
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
Other Identifiers
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I9N-MC-FCAB
Identifier Type: OTHER
Identifier Source: secondary_id
2018-002401-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17104
Identifier Type: -
Identifier Source: org_study_id
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