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

Systemic Lupus Erythematosus Clinical Trial

— ISLAND-SLE  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433585
• Other study ID #: 17422
• Secondary ID: J1P-MC-KFAJ2019-
• Status: Completed
• Phase: Phase 2
• Start date: August 19, 2020
• Est. completion date: February 16, 2023

Study information

• Verified date: March 2024
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: February 16, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• LY3471851
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
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	DOM- Centro de Reumatologia	Caba	Buenos Aires
Argentina	Centro Privado de Medicina Familiar / Mindout Research	Ciudad Autónoma de Buenos Aire	Buenos Aires
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	Centro de Investigaciones Médicas Tucuman	SAN M. DE Tucuman	Tucumán
Australia	Emeritus Research	Camberwell	Victoria
Canada	University of Calgary	Calgary	Alberta
Czechia	INREA s.r.o.	Ostrava	Ostrava Mesto
Czechia	Revmatologicky ustav	Praha 2	Praha, Hlavní Mešto
Germany	Klinikum Bad Bramstedt GmbH	Bad Bramstedt	Schleswig-Holstein
Germany	Universtitätsklinikum Essen AöR	Essen	North Rhine-Westphalia
Germany	Rheumazentrum Ruhrgebiet	Herne	Nordrhein-Westfalen
Germany	Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Universitätsklinikum Köln	Köln
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Hungary	Qualiclinic	Budapest
Hungary	Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum	Debrecen
Hungary	Békés Megyei Központi Kórház Pándy Kálmán Tagkórház	Gyula	Békés
India	Amber Clinic	Ahmedabad	Gujarat
India	Swastik Rheumatology Clinic	Ahmedabad	Gujarat
India	Government Medical College (GMC) Aurangabad	Aurangabad	Maharashtra
India	Sushruta Multispeciality Hospital & Research Centre	Hubli	Karnataka
India	Krishna Institute of Medical Science	Hyderabad	Andhra Pradesh
India	All India Institute of Medical Sciences - Nagpur	Nagpur	Maharashtra
India	Government Medical College	Nagpur	Maharashtra
India	Jasleen Hospital	Nagpur	Maharashtra
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Center for Rheumatic Diseases	Pune	Maharashtra
India	Sancheti HealthCare Academy	Pune	Maharashtra
India	Sancheti Institute for Orthopaedics & Rehabilitation	Pune	Maharashtra
India	King George Hospital	Visakhapatanam	Andhra Pradesh
Israel	Rambam Medical Center	Haifa
Israel	Meir Medical Center	Kfar Saba
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	University of Occupational and Enviromental Health	Kitakyushu	Fukuoka
Japan	Shinshu University Hospital	Matsumoto	Nagano
Japan	Kojunkai Daido Clinic	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama
Japan	Daini Osaka Police Hospital	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sasebo Chuo Hospital	Sasebo	Nagasaki
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Keio university hospital	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Korea, Republic of	Inha University Hospital	Incheon	Korea
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Hanyang University Medical Center	Seoul	Korea
Korea, Republic of	Kyung Hee University Hospital	Seoul	Korea
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul, Korea
Mexico	Centro Integral en Reumatologia	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S. C.	Guadalajara	Jalisco
Mexico	Centro Medico del Angel	Mexicali	Baja California
Mexico	Clinica para el Diagnostico y Tratamiento de la Enfermedades	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists S.A. de C.V.	Mexico City	Distrito Federal
Mexico	CIMAB SA de CV	Torreon	Coahuila
Poland	Nova Reuma Spolka Partnerska	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki Nr 2 w Bydgoszczy	Bydgoszcz
Poland	Nzoz Bif-Med	Bytom	Slaskie
Poland	MICS Centrum Medyczne Warszawa	Warszawa	Mazowieckie
Puerto Rico	Centro Reumatologico Caguas	Caguas
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Puerto Rico	Latin Clinical Trial Center	San Juan
Puerto Rico	Mindful Medical Research	San Juan
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	SC Centrul Medical Sana SRL	Bucuresti
Romania	Spitalul Clinic Sf Maria Bucuresti	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei	Galati
Russian Federation	Moscow City Clinical Hospital Number 15	Moscow	Moskva
Russian Federation	V.A. Nasonova Research Institute of Rheumatology	Moscow
Russian Federation	Karelia Republican Hospital V.A. Baranova	Petrozavodsk	Kareliya, Respublika
Russian Federation	Ryazan Regional Clinical Cardiology Dispensary	Ryazan
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Quiron Infanta Luisa	Sevilla
Taiwan	Chang Gung Memorial Hospital - Kaohsiung Branch	Kaohsiung City
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	National Taiwan University Hospital	Taipei City
Ukraine	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	Vinnytsya
Ukraine	Regional Clinical Hospital of Zaporizhzhia	Zaporizhzhia
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	Accurate Clinical Management	Baytown	Texas
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Clinical Research Center of CT/NY	Danbury	Connecticut
United States	NECCR PrimaCare Research	Fall River	Massachusetts
United States	Northwell Health	Great Neck	New York
United States	Accurate Clinical Research	Houston	Texas
United States	University of California - San Diego	La Jolla	California
United States	New Horizon Research Center	Miami	Florida
United States	University of Miami School of Medicine	Miami	Florida
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Yale University School of Medicine	New Haven	Connecticut
United States	NYU Langone	New York	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Desert Medical Advances	Palm Desert	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Stanford University Hospital	Stanford	California
United States	Fort Bend Clinical Research, LLC	Sugar Land	Texas
United States	Inland Rheumatology & Osteoporosis Medical Group	Upland	California

Sponsors (2)

Lead Sponsor	Collaborator
Nektar Therapeutics	Eli Lilly and Company

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.	Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as: Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by =1 new BILAG-2004 A or =2 new BILAG-2004 B.; No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K.; No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase =0.30 points on a 3-point PGA visual analogue scale (VAS).	Week 24
Secondary	Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24	Percentage of Participants who Achieved a SRI-4 Response at Week 24. A SRI-4 response is defined as a decrease in SLEDAI-2K >= 4 from baseline. No new BILAG A and no more than 1 new BILAG B disease activity score / organ domain (both compared with baseline), and no worsening in PGA (defined as an increase of 0.3 points [10 mm] from baseline.	Week 24
Secondary	Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24	Percentage of Participants who Achieved LLDAS at Week 24. A LLDAS response is defined as a low level of disease activity attained without use of low-dose steroids and/or standard-of-care immunosuppressant medications.	Week 24
Secondary	Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851	LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.	Week 24

External Links

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