A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04433585
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Argentina, Australia, Canada, Czechia, Germany, Hungary, India, Israel, Japan, Korea, Republic of, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: LY3471851 High Dose

LY3471851 administered subcutaneously (SC).

Experimental: LY3471851 Mid Dose

LY3471851 administered SC.

Experimental: LY3471851 Low Dose

LY3471851 administered SC

Placebo Comparator: Placebo

Placebo administered SC.

Interventions

Drug: - LY3471851

Administered SC

Drug: - Placebo

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California - San Diego, La Jolla, California

Status

Not yet recruiting

Address

University of California - San Diego

La Jolla, California, 92037

Desert Medical Advances, Palm Desert, California

Status

Recruiting

Address

Desert Medical Advances

Palm Desert, California, 92260

Stanford University Hospital, Palo Alto, California

Status

Not yet recruiting

Address

Stanford University Hospital

Palo Alto, California, 94304

Upland, California

Status

Recruiting

Address

Inland Rheumatology & Osteoporosis Medical Group

Upland, California, 91786

Aurora, Colorado

Status

Not yet recruiting

Address

University of Colorado School of Medicine

Aurora, Colorado, 80045

Clinical Research Center of CT/NY, Danbury, Connecticut

Status

Recruiting

Address

Clinical Research Center of CT/NY

Danbury, Connecticut, 06810

Yale University School of Medicine, New Haven, Connecticut

Status

Not yet recruiting

Address

Yale University School of Medicine

New Haven, Connecticut, 06519

Stamford Therapeutics Consortium, Stamford, Connecticut

Status

Recruiting

Address

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

New Horizon Research Center, Miami, Florida

Status

Recruiting

Address

New Horizon Research Center

Miami, Florida, 33165 3338

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

NECCR PrimaCare Research, Fall River, Massachusetts

Status

Recruiting

Address

NECCR PrimaCare Research

Fall River, Massachusetts, 02721

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Northwell Health, Great Neck, New York

Status

Recruiting

Address

Northwell Health

Great Neck, New York, 11021

NYU Langone, New York, New York

Status

Recruiting

Address

NYU Langone

New York, New York, 10016

Joint and Muscle Medical Care, Charlotte, North Carolina

Status

Recruiting

Address

Joint and Muscle Medical Care

Charlotte, North Carolina, 28204

MetroHealth Medical Center, Cleveland, Ohio

Status

Not yet recruiting

Address

MetroHealth Medical Center

Cleveland, Ohio, 44109

Paramount Medical Research, Middleburg Heights, Ohio

Status

Recruiting

Address

Paramount Medical Research

Middleburg Heights, Ohio, 44130

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma

Status

Recruiting

Address

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104-5046

Accurate Clinical Management, Baytown, Texas

Status

Recruiting

Address

Accurate Clinical Management

Baytown, Texas, 77521

Metroplex Clinical Research Center, Dallas, Texas

Status

Recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

Dallas, Texas

Status

Recruiting

Address

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390

Accurate Clinical Research, Houston, Texas

Status

Recruiting

Address

Accurate Clinical Research

Houston, Texas, 77089

University of Washington Medical Center, Seattle, Washington

Status

Not yet recruiting

Address

University of Washington Medical Center

Seattle, Washington, 98195-6422

International Sites

DOM- Centro de Reumatologia, Caba, Buenos Aires, Argentina

Status

Recruiting

Address

DOM- Centro de Reumatologia

Caba, Buenos Aires, 1111

Caba, Buenos Aires, Argentina

Status

Recruiting

Address

Aprillus Asistencia e Investigacion - Servicio de neurologia

Caba, Buenos Aires, C1046AAQ

Clinica Adventista Belgrano, Caba, Ciudad Autónoma De Buenos Aire, Argentina

Status

Recruiting

Address

Clinica Adventista Belgrano

Caba, Ciudad Autónoma De Buenos Aire, C1430EGF

Centro Medico Privado de Reumatologia, SAN M. DE Tucuman, Tucumán, Argentina

Status

Recruiting

Address

Centro Medico Privado de Reumatologia

SAN M. DE Tucuman, Tucumán, T4000AXL

Hospital Ramos Mejia, Ciudad Autonoma de Buenos Aire, Argentina

Status

Recruiting

Address

Hospital Ramos Mejia

Ciudad Autonoma de Buenos Aire, , C1221ADC

Ciudad Autonoma de Buenos Aire, Argentina

Status

Recruiting

Address

Centro de Medicina Familiar Mindout Research

Ciudad Autonoma de Buenos Aire, , C1417EYG

Hospital Cordoba, Cordoba, Argentina

Status

Recruiting

Address

Hospital Cordoba

Cordoba, , X5004CDT

San Juan, Argentina

Status

Recruiting

Address

Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

San Juan, , J5402DIL

Maroochydore, Queensland, Australia

Status

Recruiting

Address

The Rheumatology Research Unit Sunshine Coast

Maroochydore, Queensland, 4558

Emeritus Research, Camberwell, Victoria, Australia

Status

Recruiting

Address

Emeritus Research

Camberwell, Victoria, 3124

University of Calgary, Calgary, Alberta, Canada

Status

Not yet recruiting

Address

University of Calgary

Calgary, Alberta, T2N 4N1

NewLab Clinical Research Inc., St. John's, Newfoundland and Labrador, Canada

Status

Not yet recruiting

Address

NewLab Clinical Research Inc.

St. John's, Newfoundland and Labrador, A1C2H5

Revmatologicky ustav, Praha 2, Praha, Hlavní Mešto, Czechia

Status

Recruiting

Address

Revmatologicky ustav

Praha 2, Praha, Hlavní Mešto, 12850

INREA s.r.o., Ostrava, Czechia

Status

Recruiting

Address

INREA s.r.o.

Ostrava, , 70300

Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany

Status

Recruiting

Address

Universitätsklinikum Tübingen

Tübingen, Baden-Württemberg, 72076

Rheumazentrum Ruhrgebiet, Herne, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Rheumazentrum Ruhrgebiet

Herne, Nordrhein-Westfalen, 44649

Universtitätsklinikum Essen AöR, Essen, North Rhine-Westphalia, Germany

Status

Recruiting

Address

Universtitätsklinikum Essen AöR

Essen, North Rhine-Westphalia, 45147

Rheumaklinik Bad Branstedt GmbH, Bad Bramstedt, Schleswig-Holstein, Germany

Status

Recruiting

Address

Rheumaklinik Bad Branstedt GmbH

Bad Bramstedt, Schleswig-Holstein, 24576

Kiel, Germany

Status

Recruiting

Address

Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , 24105

Universitätsklinikum Köln, Köln, Germany

Status

Recruiting

Address

Universitätsklinikum Köln

Köln, , 50924

Bekes Megyei Pandy Kalman Korhaz, Gyula, Bekes, Hungary

Status

Recruiting

Address

Bekes Megyei Pandy Kalman Korhaz

Gyula, Bekes, 5700

Qualiclinic Kft, Budapest, Hungary

Status

Recruiting

Address

Qualiclinic Kft

Budapest, , 1036

Debrecen, Hungary

Status

Recruiting

Address

Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

Debrecen, , 4004

Krishna Institute of Medical Science, Hyderabad, Andhra Pradesh, India

Status

Not yet recruiting

Address

Krishna Institute of Medical Science

Hyderabad, Andhra Pradesh, 500003

King George Hospital, Visakhapatanam, Andhra Pradesh, India

Status

Not yet recruiting

Address

King George Hospital

Visakhapatanam, Andhra Pradesh, 530002

Sir Ganga Ram Hospital, New Delhi, Delhi, India

Status

Not yet recruiting

Address

Sir Ganga Ram Hospital

New Delhi, Delhi, 110060

Amber Clinic, Ahmedabad, Gujarat, India

Status

Not yet recruiting

Address

Amber Clinic

Ahmedabad, Gujarat, 380015

Swastik Rheumatology Clinic, Ahmedabad, Gujarat, India

Status

Not yet recruiting

Address

Swastik Rheumatology Clinic

Ahmedabad, Gujarat, 380054

Hubli, Karnataka, India

Status

Not yet recruiting

Address

Sushruta Multispecialty Hospital & Research Center Pvt Ltd

Hubli, Karnataka, 580021

Aurangabad, Maharashtra, India

Status

Not yet recruiting

Address

Government Medical College (GMC) Aurangabad

Aurangabad, Maharashtra, 431001

Government Medical College, Nagpur, Maharashtra, India

Status

Not yet recruiting

Address

Government Medical College

Nagpur, Maharashtra, 440003

Jasleen Hospital, Nagpur, Maharashtra, India

Status

Recruiting

Address

Jasleen Hospital

Nagpur, Maharashtra, 44012

Nagpur, Maharashtra, India

Status

Not yet recruiting

Address

All India Institute of Medical Sciences - Nagpur

Nagpur, Maharashtra, 441108

Pune, Maharashtra, India

Status

Recruiting

Address

Sancheti Institute for Orthopaedics & Rehabilitation

Pune, Maharashtra, 41005

Center for Rheumatic Diseases, Pune, Maharashtra, India

Status

Recruiting

Address

Center for Rheumatic Diseases

Pune, Maharashtra, 411001

Rambam Medical Center, Haifa, Israel

Status

Recruiting

Address

Rambam Medical Center

Haifa, , 3109601

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, , 4428164

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, , 5265601

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, , 6423906

Kojunkai Daido Clinic, Nagoya, Aichi, Japan

Status

Recruiting

Address

Kojunkai Daido Clinic

Nagoya, Aichi, 4570818

National Chiba-East-Hospital, Chuo-ku, Chiba, Japan

Status

Recruiting

Address

National Chiba-East-Hospital

Chuo-ku, Chiba, 260-8712

Kitakyushu, Fukuoka, Japan

Status

Recruiting

Address

University of Occupational and Enviromental Health

Kitakyushu, Fukuoka, 807-8556

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

Status

Recruiting

Address

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648

Tohoku University Hospital, Sendai-shi, Miyagi, Japan

Status

Recruiting

Address

Tohoku University Hospital

Sendai-shi, Miyagi, 980-8574

Shinshu University Hospital, Matsumoto, Nagano, Japan

Status

Recruiting

Address

Shinshu University Hospital

Matsumoto, Nagano, 390-8621

Sasebo Chuo Hospital, Sasebo, Nagasaki, Japan

Status

Recruiting

Address

Sasebo Chuo Hospital

Sasebo, Nagasaki, 857-1195

St. Lukes International Hospital, Chuo-Ku, Tokyo, Japan

Status

Recruiting

Address

St. Lukes International Hospital

Chuo-Ku, Tokyo, 104 8560

Keio University Hospital, Shinjuku-Ku, Tokyo, Japan

Status

Recruiting

Address

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582

Fukuoka, Japan

Status

Recruiting

Address

National Hospital Organization Kyushu Medical Center

Fukuoka, , 810 8563

Okayama University Hospital, Okayama, Japan

Status

Recruiting

Address

Okayama University Hospital

Okayama, , 700-8558

Daini Osaka Police Hospital, Osaka, Japan

Status

Recruiting

Address

Daini Osaka Police Hospital

Osaka, , 543-0042

Seongnam-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620

Inha University Hospital, Incheon, Korea, Korea, Republic of

Status

Recruiting

Address

Inha University Hospital

Incheon, Korea, 22332

Kyung Hee University Hospital, Seoul, Korea, Korea, Republic of

Status

Not yet recruiting

Address

Kyung Hee University Hospital

Seoul, Korea, 02447

Hanyang University Medical Center, Seoul, Korea, Korea, Republic of

Status

Recruiting

Address

Hanyang University Medical Center

Seoul, Korea, 04763

Seoul National University Hospital, Seoul, Seoul, Korea, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, Seoul, Korea, 03080

Centro Medico del Angel, Mexicali, Baja California, Mexico

Status

Not yet recruiting

Address

Centro Medico del Angel

Mexicali, Baja California, 21100

Dr. Alberto Esteban Bazzoni Ruiz, Torreon, Coahuila, Mexico

Status

Recruiting

Address

Dr. Alberto Esteban Bazzoni Ruiz

Torreon, Coahuila, 27000

RM Pharma Specialists S.A. de C.V., Mexico City, Distrito Federal, Mexico

Status

Not yet recruiting

Address

RM Pharma Specialists S.A. de C.V.

Mexico City, Distrito Federal, 03100

Mexico City, Distrito Federal, Mexico

Status

Not yet recruiting

Address

Clinica para el Diagnostico y Tratamiento de la Enfermedades

Mexico City, Distrito Federal, 06700

Centro Integral en Reumatologia SA de CV, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Centro Integral en Reumatologia SA de CV

Guadalajara, Jalisco, 44160

Guadalajara, Jalisco, Mexico

Status

Not yet recruiting

Address

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Jalisco, 44650

Diamond Clinic, Krakow, Malopolskie, Poland

Status

Recruiting

Address

Diamond Clinic

Krakow, Malopolskie, 31-559

Medycyna Kliniczna, Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Medycyna Kliniczna

Warszawa, Mazowieckie, 00874

Reuma Clinic, Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Reuma Clinic

Bialystok, Podlaskie, 15-166

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

Bydgoszcz, , 85-168

Nzoz Bif-Med, Bytom, Śląskie, Poland

Status

Recruiting

Address

Nzoz Bif-Med

Bytom, Śląskie, 41-902

Centro Reumatologico Caguas, Caguas', Puerto Rico

Status

Recruiting

Address

Centro Reumatologico Caguas

Caguas', , 00725

Latin Clinical Trial Center, San Juan, Puerto Rico

Status

Recruiting

Address

Latin Clinical Trial Center

San Juan, , 00909

GCM Medical Group, PSC - Hato Rey Site, San Juan, Puerto Rico

Status

Recruiting

Address

GCM Medical Group, PSC - Hato Rey Site

San Juan, , 00917

Mindful Medical Research, San Juan, Puerto Rico

Status

Recruiting

Address

Mindful Medical Research

San Juan, , 00918

SC CMDTA Neomed SRL, Brasov, Romania

Status

Recruiting

Address

SC CMDTA Neomed SRL

Brasov, , 500283

SC Centrul Medical Sana SRL, Bucuresti, Romania

Status

Recruiting

Address

SC Centrul Medical Sana SRL

Bucuresti, , 011025

Spitalul Clinic Sf Maria Bucuresti, Bucuresti, Romania

Status

Recruiting

Address

Spitalul Clinic Sf Maria Bucuresti

Bucuresti, , 011172

Spitalul Clinic Sf Maria Bucuresti, Bucuresti, Romania

Status

Recruiting

Address

Spitalul Clinic Sf Maria Bucuresti

Bucuresti, , 011172

Galati, Romania

Status

Recruiting

Address

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

Galati, , 800578

Moscow, Russian Federation

Status

Not yet recruiting

Address

City Clinical Hospital #15 named after O.M. Filatov

Moscow, , 111539

Moscow, Russian Federation

Status

Recruiting

Address

V.A. Nasonova Research Institute of Rheumatology

Moscow, , 115522

Petrozavodsk, Russian Federation

Status

Recruiting

Address

Karelia Republican Hospital V.A. Baranova

Petrozavodsk, , 185019

Ryazan, Russian Federation

Status

Recruiting

Address

Ryazan Regional Clinical Cardiology Dispensary

Ryazan, , 390026

Centre Medico Teknon, Barcelona, Spain

Status

Recruiting

Address

Centre Medico Teknon

Barcelona, , 08022

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, , 08035

Hospital Quiron Infanta Luisa, Sevilla, Spain

Status

Recruiting

Address

Hospital Quiron Infanta Luisa

Sevilla, , 41010

Kaohsiung City, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, , 83301

China Medical University Hospital, Taichung City, Taiwan

Status

Recruiting

Address

China Medical University Hospital

Taichung City, , 40447

Taichung Veterans General Hospital, Taichung, Taiwan

Status

Recruiting

Address

Taichung Veterans General Hospital

Taichung, , 40705

National Taiwan University Hospital, Taipei City, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei City, , 10048

Kharkiv, Ukraine

Status

Recruiting

Address

Regional Clinical Hospital Center for Emergency medical care

Kharkiv, ,

Edelweiss Medics LLC, Kyiv, Ukraine

Status

Recruiting

Address

Edelweiss Medics LLC

Kyiv, , 02002

Kyiv, Ukraine

Status

Recruiting

Address

National Scientific Center "Strazhesko institute of cardio"

Kyiv, , 03680

Kyiv City Clinical Hospital #3, Kyiv, Ukraine

Status

Recruiting

Address

Kyiv City Clinical Hospital #3

Kyiv, ,

Odesa, Ukraine

Status

Recruiting

Address

Multifield Medical Center of Odesa NMU (University Clinic#1)

Odesa, , 65026

Vinnytsya Regional Clinical Hospital, Vinnytsya, Ukraine

Status

Recruiting

Address

Vinnytsya Regional Clinical Hospital

Vinnytsya, , 21018

Zaporizhzhia, Ukraine

Status

Recruiting

Address

Regional Clinical Hospital of Zaporizhzhia

Zaporizhzhia, , 69600