Back to resultsA Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3471851
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring T regulatory cells (Tregs), Interleukin 2, Interleukin-2
Eligibility Criteria
Inclusion Criteria:
- Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
- Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
- Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
- Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
- Have a clinical SLEDAI-2K score ≥4 at randomization.
- Have active arthritis and/or active rash.
Exclusion Criteria:
- Have severe active lupus nephritis.
- Have active central nervous system (CNS) lupus.
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
Sites / Locations
- University of California - San Diego
- Desert Medical Advances
- Stanford University Hospital
- Inland Rheumatology & Osteoporosis Medical Group
- University of Colorado School of Medicine
- Clinical Research Center of CT/NY
- Yale University School of Medicine
- Stamford Therapeutics Consortium
- University of Miami School of Medicine
- New Horizon Research Center
- NECCR PrimaCare Research
- Washington University School of Medicine
- Northwell Health
- NYU Langone
- MetroHealth Medical Center
- Paramount Medical Research
- Oklahoma Medical Research Foundation
- Accurate Clinical Management
- Metroplex Clinical Research Center
- University of Texas Southwestern Medical Center at Dallas
- Accurate Clinical Research
- Fort Bend Clinical Research, LLC
- University of Washington Medical Center
- DOM- Centro de Reumatologia
- Centro Privado de Medicina Familiar / Mindout Research
- APRILLUS Asistencia E Investigacion de Arcis Salud
- Clinica Adventista Belgrano
- Centro de Investigaciones Médicas Tucuman
- Hospital J. M. Ramos Mejía
- Hospital Córdoba
- Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
- Emeritus Research
- University of Calgary
- INREA s.r.o.
- Revmatologicky ustav
- Universitätsklinikum Tübingen
- Rheumazentrum Ruhrgebiet
- Universtitätsklinikum Essen AöR
- Klinikum Bad Bramstedt GmbH
- Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
- Universitätsklinikum Köln
- Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
- Qualiclinic
- Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
- Krishna Institute of Medical Science
- King George Hospital
- Sir Ganga Ram Hospital
- Amber Clinic
- Swastik Rheumatology Clinic
- Sushruta Multispeciality Hospital & Research Centre
- Government Medical College (GMC) Aurangabad
- Government Medical College
- Jasleen Hospital
- All India Institute of Medical Sciences - Nagpur
- Sancheti Institute for Orthopaedics & Rehabilitation
- Center for Rheumatic Diseases
- Sancheti HealthCare Academy
- Sheba Medical Center
- Rambam Medical Center
- Meir Medical Center
- Tel Aviv Sourasky Medical Center
- Kojunkai Daido Clinic
- University of Occupational and Enviromental Health
- Hokkaido University Hospital
- Tohoku University Hospital
- Shinshu University Hospital
- Sasebo Chuo Hospital
- National Hospital Organization Chibahigashi National Hospital
- National Hospital Organization Kyushu Medical Center
- Okayama University Hospital
- Daini Osaka Police Hospital
- St. Luke's International Hospital
- Keio university hospital
- Seoul National University Bundang Hospital
- Inha University Hospital
- Kyung Hee University Hospital
- Hanyang University Medical Center
- Seoul National University Hospital
- Centro Medico del Angel
- CIMAB SA de CV
- RM Pharma Specialists S.A. de C.V.
- Clinica para el Diagnostico y Tratamiento de la Enfermedades
- Centro Integral en Reumatologia
- Clinica de Investigacion en Reumatologia y Obesidad S. C.
- MICS Centrum Medyczne Warszawa
- Nova Reuma Społka Partnerska
- Szpital Uniwersytecki Nr 2 w Bydgoszczy
- Nzoz Bif-Med
- Centro Reumatologico Caguas
- Latin Clinical Trial Center
- GCM Medical Group, PSC - Hato Rey Site
- Mindful Medical Research
- C.M.D.T.A. Neomed
- SC Centrul Medical Sana SRL
- Spitalul Clinic Sf Maria Bucuresti
- Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
- Karelia Republican Hospital V.A. Baranova
- Moscow City Clinical Hospital Number 15
- V.A. Nasonova Research Institute of Rheumatology
- Ryazan Regional Clinical Cardiology Dispensary
- Hospital Universitari Vall d'Hebron
- Hospital Quiron Infanta Luisa
- Chang Gung Memorial Hospital - Kaohsiung Branch
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Taiwan University Hospital
- Regional Clinical Hospital Center for Emergency medical care
- Edelweiss Medics LLC
- Kyiv City Clinical Hospital #3
- Multifield Medical Center of Odesa NMU (University Clinic#1)
- Vinnytsya Regional Clinical Hospital
- Regional Clinical Hospital of Zaporizhzhia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
LY3471851 High Dose
LY3471851 Mid Dose
LY3471851 Low Dose
Placebo
Arm Description
LY3471851 administered subcutaneously (SC).
LY3471851 administered SC.
LY3471851 administered SC
Placebo administered SC.
Outcomes
Primary Outcome Measures
Percentage of Participants who Achieve a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score
Percentage of Participants who Achieve a ≥4 Point Reduction in SLEDAI-2K Score
Secondary Outcome Measures
Percentage of Participants who Achieve British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response
Percentage of Participants who Achieve BICLA Response
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
Percentage of Participants who Achieve SRI-4 Response
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS)
Percentage of Participants who Achieve LLDAS
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
PK: Ctrough of LY3471851
Full Information
NCT ID
NCT04433585
First Posted
June 15, 2020
Last Updated
April 12, 2023
Sponsor
Eli Lilly and Company
Collaborators
Nektar Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT04433585
Brief Title
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Acronym
ISLAND-SLE
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
February 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Nektar Therapeutics
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 LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).
Detailed Description
LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
T regulatory cells (Tregs), Interleukin 2, Interleukin-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3471851 High Dose
Arm Type
Experimental
Arm Description
LY3471851 administered subcutaneously (SC).
Arm Title
LY3471851 Mid Dose
Arm Type
Experimental
Arm Description
LY3471851 administered SC.
Arm Title
LY3471851 Low Dose
Arm Type
Experimental
Arm Description
LY3471851 administered SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3471851
Other Intervention Name(s)
NKTR-358
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score
Description
Percentage of Participants who Achieve a ≥4 Point Reduction in SLEDAI-2K Score
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response
Description
Percentage of Participants who Achieve BICLA Response
Time Frame
Week 24
Title
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
Description
Percentage of Participants who Achieve SRI-4 Response
Time Frame
Week 24
Title
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS)
Description
Percentage of Participants who Achieve LLDAS
Time Frame
Week 24
Title
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
Description
PK: Ctrough of LY3471851
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
Have a clinical SLEDAI-2K score ≥4 at randomization.
Have active arthritis and/or active rash.
Exclusion Criteria:
Have severe active lupus nephritis.
Have active central nervous system (CNS) lupus.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
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
University of California - San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Inland Rheumatology & Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Clinical Research Center of CT/NY
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165 3338
Country
United States
Facility Name
NECCR PrimaCare Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Paramount Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5046
Country
United States
Facility Name
Accurate Clinical Management
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Fort Bend Clinical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6422
Country
United States
Facility Name
DOM- Centro de Reumatologia
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1111
Country
Argentina
Facility Name
Centro Privado de Medicina Familiar / Mindout Research
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1417
Country
Argentina
Facility Name
APRILLUS Asistencia E Investigacion de Arcis Salud
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
1406
Country
Argentina
Facility Name
Clinica Adventista Belgrano
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Tucuman
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Hospital J. M. Ramos Mejía
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Hospital Córdoba
City
Córdoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
INREA s.r.o.
City
Ostrava
State/Province
Ostrava Město
ZIP/Postal Code
70300
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
State/Province
Praha, Hlavní Mešto
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44649
Country
Germany
Facility Name
Universtitätsklinikum Essen AöR
City
Essen
State/Province
North Rhine-Westphalia
ZIP/Postal Code
45147
Country
Germany
Facility Name
Klinikum Bad Bramstedt GmbH
City
Bad Bramstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
24576
Country
Germany
Facility Name
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
City
Gyula
State/Province
Békés
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Qualiclinic
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Krishna Institute of Medical Science
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
King George Hospital
City
Visakhapatanam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Amber Clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Swastik Rheumatology Clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
Sushruta Multispeciality Hospital & Research Centre
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580021
Country
India
Facility Name
Government Medical College (GMC) Aurangabad
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Government Medical College
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
Jasleen Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
All India Institute of Medical Sciences - Nagpur
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
441108
Country
India
Facility Name
Sancheti Institute for Orthopaedics & Rehabilitation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
41005
Country
India
Facility Name
Center for Rheumatic Diseases
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Sancheti HealthCare Academy
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411005
Country
India
Facility Name
Sheba Medical Center
City
Ramat Gan
State/Province
HaMerkaz
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Kojunkai Daido Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4570818
Country
Japan
Facility Name
University of Occupational and Enviromental Health
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Sasebo Chuo Hospital
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
National Hospital Organization Chibahigashi National Hospital
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810 8563
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Daini Osaka Police Hospital
City
Osaka
ZIP/Postal Code
543-0042
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Keio university hospital
City
Tokyo
ZIP/Postal Code
160 8582
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
State/Province
Korea
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul, Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Centro Medico del Angel
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21100
Country
Mexico
Facility Name
CIMAB SA de CV
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
RM Pharma Specialists S.A. de C.V.
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Clinica para el Diagnostico y Tratamiento de la Enfermedades
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Centro Integral en Reumatologia
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S. C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
MICS Centrum Medyczne Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00874
Country
Poland
Facility Name
Nova Reuma Społka Partnerska
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-707
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Nzoz Bif-Med
City
Bytom
State/Province
Śląskie
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Centro Reumatologico Caguas
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Mindful Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
C.M.D.T.A. Neomed
City
Brasov
State/Province
Brașov
ZIP/Postal Code
500283
Country
Romania
Facility Name
SC Centrul Medical Sana SRL
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Spitalul Clinic Sf Maria Bucuresti
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
Karelia Republican Hospital V.A. Baranova
City
Petrozavodsk
State/Province
Kareliya, Respublika
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital Number 15
City
Moscow
State/Province
Moskva
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
V.A. Nasonova Research Institute of Rheumatology
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Cardiology Dispensary
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Chang Gung Memorial Hospital - Kaohsiung Branch
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Regional Clinical Hospital Center for Emergency medical care
City
Kharkiv
Country
Ukraine
Facility Name
Edelweiss Medics LLC
City
Kyiv
ZIP/Postal Code
02002
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #3
City
Kyiv
Country
Ukraine
Facility Name
Multifield Medical Center of Odesa NMU (University Clinic#1)
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Hospital
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Regional Clinical Hospital of Zaporizhzhia
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
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
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/2NrKmN7Zwj52k3UG9QrLqS
Description
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)
Learn more about this trial
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
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