A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT04433585
Last Updated: 2024-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
291 participants
INTERVENTIONAL
2020-08-19
2023-02-16
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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LY3471851 High Dose
LY3471851 administered subcutaneously (SC).
LY3471851
Administered SC
LY3471851 Mid Dose
LY3471851 administered SC.
LY3471851
Administered SC
LY3471851 Low Dose
LY3471851 administered SC
LY3471851
Administered SC
Placebo
Placebo administered SC.
Placebo
Administered SC
Interventions
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LY3471851
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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University of California - San Diego
La Jolla, California, United States
Desert Medical Advances
Palm Desert, California, United States
Stanford University Hospital
Stanford, California, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
University of Miami School of Medicine
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Northwell Health
Great Neck, New York, United States
NYU Langone
New York, New York, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Paramount Medical Research
Middleburg Heights, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Accurate Clinical Management
Baytown, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Fort Bend Clinical Research, LLC
Sugar Land, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
DOM- Centro de Reumatologia
CABA, Buenos Aires, Argentina
Centro Privado de Medicina Familiar / Mindout Research
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
APRILLUS Asistencia E Investigacion de Arcis Salud
CABA, Ciudad Autónoma de Buenos Aire, Argentina
Clinica Adventista Belgrano
CABA, Ciudad Autónoma de Buenos Aire, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, Argentina
Hospital J. M. Ramos Mejía
Ciudad Autónoma de Buenos Aire, , Argentina
Hospital Córdoba
Córdoba, , Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
San Juan, , Argentina
Emeritus Research
Camberwell, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
INREA s.r.o.
Ostrava, Ostrava Město, Czechia
Revmatologicky ustav
Prague, Praha, Hlavní Mešto, Czechia
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universtitätsklinikum Essen AöR
Essen, North Rhine-Westphalia, Germany
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, Germany
Klinikum Bad Bramstedt GmbH
Bad Bramstedt, Schleswig-Holstein, Germany
Universitätsklinikum Köln
Cologne, , Germany
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
Gyula, Bekes County, Hungary
Qualiclinic
Budapest, , Hungary
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, , Hungary
Krishna Institute of Medical Science
Hyderabad, Andhra Pradesh, India
King George Hospital
Visakhapatanam, Andhra Pradesh, India
Amber Clinic
Ahmedabad, Gujarat, India
Swastik Rheumatology Clinic
Ahmedabad, Gujarat, India
Sushruta Multispeciality Hospital & Research Centre
Hubli, Karnataka, India
Government Medical College (GMC) Aurangabad
Aurangabad, Maharashtra, India
Government Medical College
Nagpur, Maharashtra, India
Jasleen Hospital
Nagpur, Maharashtra, India
All India Institute of Medical Sciences - Nagpur
Nagpur, Maharashtra, India
Sancheti Institute for Orthopaedics & Rehabilitation
Pune, Maharashtra, India
Center for Rheumatic Diseases
Pune, Maharashtra, India
Sancheti HealthCare Academy
Pune, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Sheba Medical Center
Ramat Gan, Central District, Israel
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Kojunkai Daido Clinic
Nagoya, Aichi-ken, Japan
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Okayama University Hospital
Okayama, , Japan
Daini Osaka Police Hospital
Osaka, , Japan
St. Luke's International Hospital
Tokyo, , Japan
Keio university hospital
Tokyo, , Japan
CIMAB SA de CV
Torreón, Coahuila, Mexico
Centro Medico del Angel
Mexicali, Estado de Baja California, Mexico
Centro Integral en Reumatologia
Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, Mexico
RM Pharma Specialists S.A. de C.V.
Mexico City, Mexico City, Mexico
Clinica para el Diagnostico y Tratamiento de la Enfermedades
Mexico City, Mexico City, Mexico
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, Poland
Nova Reuma Społka Partnerska
Bialystok, Podlaskie Voivodeship, Poland
Nzoz Bif-Med
Bytom, Silesian Voivodeship, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, , Poland
Centro Reumatologico Caguas
Caguas, PR, Puerto Rico
Latin Clinical Trial Center
San Juan, PR, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, Puerto Rico
Mindful Medical Research
San Juan, PR, Puerto Rico
C.M.D.T.A. Neomed
Brasov, Brașov County, Romania
SC Centrul Medical Sana SRL
Bucharest, , Romania
Spitalul Clinic Sf Maria Bucuresti
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
Galati, , Romania
Karelia Republican Hospital V.A. Baranova
Petrozavodsk, Kareliya, Respublika, Russia
Moscow City Clinical Hospital Number 15
Moscow, Moscow, Russia
V.A. Nasonova Research Institute of Rheumatology
Moscow, , Russia
Ryazan Regional Clinical Cardiology Dispensary
Ryazan, , Russia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, Korea, South Korea
Kyung Hee University Hospital
Seoul, Korea, South Korea
Hanyang University Medical Center
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, Seoul, Korea, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Quiron Infanta Luisa
Seville, , Spain
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Regional Clinical Hospital Center for Emergency medical care
Kharkiv, , Ukraine
Edelweiss Medics LLC
Kyiv, , Ukraine
Kyiv City Clinical Hospital #3
Kyiv, , Ukraine
Multifield Medical Center of Odesa NMU (University Clinic#1)
Odesa, , Ukraine
Vinnytsya Regional Clinical Hospital
Vinnytsia, , Ukraine
Regional Clinical Hospital of Zaporizhzhia
Zaporizhzhia, , Ukraine
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 LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)
Other Identifiers
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J1P-MC-KFAJ
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003323-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17422
Identifier Type: -
Identifier Source: org_study_id
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