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

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3375880
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, atopic eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology
  • Dermatology Research Associates
  • Quest Dermatology Research
  • Integrative Skin Science and Research
  • Arlington Dermatology
  • The South Bend Clinic
  • Dermatology and Skin Cancer Specialists
  • ActivMed Practices & Research, Inc
  • Piedmont Plastic Surgery and Dermatology
  • PMG Research of Wilmington, LLC
  • Hightower Clinical Trial Services
  • Oregon Dermatology and Research Center
  • Clinical Partners LLC
  • Center for Clinical Studies
  • DOM- Centro de Reumatologia
  • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires Skin
  • Instituto de Neumonología y Dermatología
  • Psoriahue Medicina Interdisciplinaria
  • Parra Dermatología
  • Centro Medico Privado de Reumatologia
  • Universitätsklinikum Graz
  • LKH Feldkirch
  • Sozialmed. Zentrum Ost - Donauspital
  • The Guenther Dermatology Research Centre
  • Clintrial, s.r.o.
  • Sanatorium Profesora Arenbergera
  • CHU de Nice Hopital de L'Archet
  • Dermatologikum Hamburg
  • TFS Trial Form Support GmbH
  • Oroshaza Varosi Onkormanyzat Korhaza
  • Allergo-Derm Bakos Kft
  • UNO Medical Trials Kft.
  • MedMare Bt
  • Policlinico di Tor Vergata
  • Istituto Clinico Humanitas
  • Polic.Umberto I -Univ. La Sapienza
  • Yasumoto Dermatology Clinic
  • Takagi Dermatological Clinic
  • Kobe University Hospital
  • Meiwa Hospital
  • Kyoto Prefectural University of Medicine
  • Oita University Hospital
  • Kume Clinic
  • Dokkyo Medical University Saitama Medical Center
  • Sumire Dermatology Clinic
  • Matsuda Tomoko Dematological Clinic
  • Grupo Medico Camino S.C.
  • Derma Norte del Bajío, S.C.
  • Office of Dr. Samuel Sanchez PSC
  • Office of Dr. Alma M. Cruz
  • Ponce School of Medicine CAIMED Center
  • Clinical Research Puerto Rico, Inc.
  • GCM Medical Group PSC
  • Hospital Universitari de Bellvitge
  • Clinica Universitaria De Navarra
  • Clinica Universidad De Navarra
  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

50 mg LY3375880

150 mg LY3375880

600 mg LY3375880

Placebo

Arm Description

Induction Period: Participants received 50 mg LY3375880 administered SC Q4W.

Induction Period: Participants received 150 mg LY3375880 administered SC Q4W.

Induction Period: Participants received 600 mg LY3375880 administered SC Q4W.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
February 4, 2019
Last Updated
March 24, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03831191
Brief Title
A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
Acronym
ADmIRe
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated for lack of efficacy after an interim analysis was performed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema, atopic eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 mg LY3375880
Arm Type
Experimental
Arm Description
Induction Period: Participants received 50 mg LY3375880 administered SC Q4W.
Arm Title
150 mg LY3375880
Arm Type
Experimental
Arm Description
Induction Period: Participants received 150 mg LY3375880 administered SC Q4W.
Arm Title
600 mg LY3375880
Arm Type
Experimental
Arm Description
Induction Period: Participants received 600 mg LY3375880 administered SC Q4W.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
Intervention Type
Drug
Intervention Name(s)
LY3375880
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Achieving vIGA-AD of 0
Description
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.
Time Frame
Week 16
Title
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
Description
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.
Time Frame
Baseline, Week 16
Title
Mean Change From Baseline in SCORAD
Description
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.
Time Frame
Baseline, Week 16
Title
Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52
Description
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.
Time Frame
Week 52
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Quest Dermatology Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Arlington Dermatology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
The South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Dermatology and Skin Cancer Specialists
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
ActivMed Practices & Research, Inc
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Piedmont Plastic Surgery and Dermatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Facility Name
Hightower Clinical Trial Services
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Clinical Partners LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
DOM- Centro de Reumatologia
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1111
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Buenos Aires Skin
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1055AA0
Country
Argentina
Facility Name
Instituto de Neumonología y Dermatología
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425BEA
Country
Argentina
Facility Name
Psoriahue Medicina Interdisciplinaria
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425DKG
Country
Argentina
Facility Name
Parra Dermatología
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Universitätsklinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
LKH Feldkirch
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6807
Country
Austria
Facility Name
Sozialmed. Zentrum Ost - Donauspital
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Clintrial, s.r.o.
City
Praha 10
State/Province
Hl. M. Praha
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Sanatorium Profesora Arenbergera
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
CHU de Nice Hopital de L'Archet
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Dermatologikum Hamburg
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
TFS Trial Form Support GmbH
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Oroshaza Varosi Onkormanyzat Korhaza
City
Oroshaza
State/Province
Bekes
ZIP/Postal Code
5900-H
Country
Hungary
Facility Name
Allergo-Derm Bakos Kft
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
MedMare Bt
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Policlinico di Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Polic.Umberto I -Univ. La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Yasumoto Dermatology Clinic
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818 0083
Country
Japan
Facility Name
Takagi Dermatological Clinic
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Meiwa Hospital
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8186
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Oita University Hospital
City
Yufu-shi
State/Province
Oita
ZIP/Postal Code
8795593
Country
Japan
Facility Name
Kume Clinic
City
Nishi-ku Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343 8555
Country
Japan
Facility Name
Sumire Dermatology Clinic
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
133-0057
Country
Japan
Facility Name
Matsuda Tomoko Dematological Clinic
City
Fukuoka
ZIP/Postal Code
819 0167
Country
Japan
Facility Name
Grupo Medico Camino S.C.
City
México City
State/Province
Distrito Federal
ZIP/Postal Code
03310
Country
Mexico
Facility Name
Derma Norte del Bajío, S.C.
City
Aguascalientes
Country
Mexico
Facility Name
Office of Dr. Samuel Sanchez PSC
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Facility Name
Office of Dr. Alma M. Cruz
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Facility Name
Ponce School of Medicine CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico, Inc.
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group PSC
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Clinica Universitaria De Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Clinica Universidad De Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.clinicalstudydatarequest.com
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/4hXeeEjeZhqtnDW4onAZx3#?postal=
Description
A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis

Learn more about this trial

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

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