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

NCT04433585 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 17422J1P-MC-KFAJ2019-003323-38
• Study Type: interventional
• Target: 291
• Locations: 19 countries
• Sites: 112

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).

Conditions

Systemic Lupus Erythematosus

Keywords

T regulatory cells (Tregs); Interleukin 2; Interleukin-2

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24

  Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).

  Week 24

Secondary Outcomes (4)

• Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.

  Week 24

• Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24

  Week 24

• Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24

  Week 24

• Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851

  Week 24

Study Arms (4)

LY3471851 High Dose

EXPERIMENTAL

LY3471851 administered subcutaneously (SC).

Drug: LY3471851

LY3471851 Mid Dose

EXPERIMENTAL

LY3471851 administered SC.

Drug: LY3471851

LY3471851 Low Dose

EXPERIMENTAL

LY3471851 administered SC

Drug: LY3471851

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3471851 DRUG

Administered SC

Also known as: Rezpegaldesleukin, REZPEG, NKTR-358

LY3471851 High Dose; LY3471851 Low Dose; LY3471851 Mid Dose

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nektar Therapeutics: lead
• Eli Lilly and Company: collaborator

Study Sites (112)

University of California - San Diego

La Jolla, California, 92037, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Stanford University Hospital

Stanford, California, 94305, United States

Location

Inland Rheumatology & Osteoporosis Medical Group

Upland, California, 91786, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Clinical Research Center of CT/NY

Danbury, Connecticut, 06810, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

New Horizon Research Center

Miami, Florida, 33165 3338, United States

Location

NECCR PrimaCare Research

Fall River, Massachusetts, 02721, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Paramount Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104-5046, United States

Location

Accurate Clinical Management

Baytown, Texas, 77521, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Accurate Clinical Research

Houston, Texas, 77089, United States

Location

Fort Bend Clinical Research, LLC

Sugar Land, Texas, 77479, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6422, United States

Location

DOM- Centro de Reumatologia

CABA, Buenos Aires, 1111, Argentina

Location

Centro Privado de Medicina Familiar / Mindout Research

Ciudad Autónoma de Buenos Aire, Buenos Aires, 1417, Argentina

Location

APRILLUS Asistencia E Investigacion de Arcis Salud

CABA, Ciudad Autónoma de Buenos Aire, 1406, Argentina

Location

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, C1430EGF, Argentina

Location

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

Location

Hospital J. M. Ramos Mejía

Ciudad Autónoma de Buenos Aire, C1221ADC, Argentina

Location

Hospital Córdoba

Córdoba, 5004, Argentina

Location

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

San Juan, J5402DIL, Argentina

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

INREA s.r.o.

Ostrava, Ostrava Město, 70300, Czechia

Location

Revmatologicky ustav

Prague, Praha, Hlavní Mešto, 12850, Czechia

Location

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universtitätsklinikum Essen AöR

Essen, North Rhine-Westphalia, 45147, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, North Rhine-Westphalia, 44649, Germany

Location

Klinikum Bad Bramstedt GmbH

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

Location

Universitätsklinikum Köln

Cologne, 50924, Germany

Location

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

Kiel, 24105, Germany

Location

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

Gyula, Bekes County, 5700, Hungary

Location

Qualiclinic

Budapest, 1036, Hungary

Location

Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

Debrecen, 4004, Hungary

Location

Krishna Institute of Medical Science

Hyderabad, Andhra Pradesh, 500003, India

Location

King George Hospital

Visakhapatanam, Andhra Pradesh, 530002, India

Location

Amber Clinic

Ahmedabad, Gujarat, 380015, India

Location

Swastik Rheumatology Clinic

Ahmedabad, Gujarat, 380054, India

Location

Sushruta Multispeciality Hospital & Research Centre

Hubli, Karnataka, 580021, India

Location

Government Medical College (GMC) Aurangabad

Aurangabad, Maharashtra, 431001, India

Location

Government Medical College

Nagpur, Maharashtra, 440003, India

Location

Jasleen Hospital

Nagpur, Maharashtra, 440012, India

Location

All India Institute of Medical Sciences - Nagpur

Nagpur, Maharashtra, 441108, India

Location

Sancheti Institute for Orthopaedics & Rehabilitation

Pune, Maharashtra, 41005, India

Location

Center for Rheumatic Diseases

Pune, Maharashtra, 411001, India

Location

Sancheti HealthCare Academy

Pune, Maharashtra, 411005, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Kojunkai Daido Clinic

Nagoya, Aichi-ken, 4570818, Japan

Location

University of Occupational and Enviromental Health

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Shinshu University Hospital

Matsumoto, Nagano, 390-8621, Japan

Location

Sasebo Chuo Hospital

Sasebo, Nagasaki, 857-1195, Japan

Location

National Hospital Organization Chibahigashi National Hospital

Chiba, 260-8712, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810 8563, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Daini Osaka Police Hospital

Osaka, 543-0042, Japan

Location

St. Luke's International Hospital

Tokyo, 104-8560, Japan

Location

Keio university hospital

Tokyo, 160 8582, Japan

Location

CIMAB SA de CV

Torreón, Coahuila, 27000, Mexico

Location

Centro Medico del Angel

Mexicali, Estado de Baja California, 21100, Mexico

Location

Centro Integral en Reumatologia

Guadalajara, Jalisco, 44160, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Jalisco, 44650, Mexico

Location

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

Mexico City, Mexico City, 03100, Mexico

Location

Clinica para el Diagnostico y Tratamiento de la Enfermedades

Mexico City, Mexico City, 06700, Mexico

Location

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, 00874, Poland

Location

Nova Reuma Społka Partnerska

Bialystok, Podlaskie Voivodeship, 15-707, Poland

Location

Nzoz Bif-Med

Bytom, Silesian Voivodeship, 41-902, Poland

Location

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

Centro Reumatologico Caguas

Caguas, PR, 00725, Puerto Rico

Location

Latin Clinical Trial Center

San Juan, PR, 00909, Puerto Rico

Location

GCM Medical Group, PSC - Hato Rey Site

San Juan, PR, 00917, Puerto Rico

Location

Mindful Medical Research

San Juan, PR, 00918, Puerto Rico

Location

C.M.D.T.A. Neomed

Brasov, Brașov County, 500283, Romania

Location

SC Centrul Medical Sana SRL

Bucharest, 011025, Romania

Location

Spitalul Clinic Sf Maria Bucuresti

Bucharest, 011172, Romania

Location

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

Galati, 800578, Romania

Location

Karelia Republican Hospital V.A. Baranova

Petrozavodsk, Kareliya, Respublika, 185019, Russia

Location

Moscow City Clinical Hospital Number 15

Moscow, Moscow, 111539, Russia

Location

V.A. Nasonova Research Institute of Rheumatology

Moscow, 115522, Russia

Location

Ryazan Regional Clinical Cardiology Dispensary

Ryazan, 390026, Russia

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Inha University Hospital

Incheon, Korea, 22332, South Korea

Location

Kyung Hee University Hospital

Seoul, Korea, 02447, South Korea

Location

Hanyang University Medical Center

Seoul, Korea, 04763, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, Korea, 03080, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Quiron Infanta Luisa

Seville, 41010, Spain

Location

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Regional Clinical Hospital Center for Emergency medical care

Kharkiv, Ukraine

Location

Edelweiss Medics LLC

Kyiv, 02002, Ukraine

Location

Kyiv City Clinical Hospital #3

Kyiv, Ukraine

Location

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

Odesa, 65026, Ukraine

Location

Vinnytsya Regional Clinical Hospital

Vinnytsia, 21018, Ukraine

Location

Regional Clinical Hospital of Zaporizhzhia

Zaporizhzhia, 69600, Ukraine

Location

Related Links

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

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Nektar Therapeutics

StudyInquiry@nektar.com

8554828676

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 16, 2020
• Study Start: August 19, 2020
• Primary Completion: January 10, 2023
• Study Completion: February 16, 2023
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (6); PR (4); TW (4); RU (4); CA (1); AU (1); ES (2); PL (4); RO (4); US (23); IL (4); HU (3); DE (6); IN (13); CZ (2); JP (12); AR (8); ME (6); KR (5)