Clinical trial NCT04433585: A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: T regulatory cells (Tregs)
Interleukin 2
Interleukin-2
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2020-06-16
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.
timeFrame: Week 24
measure: Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24
timeFrame: Week 24
measure: Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
timeFrame: Week 24
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California - San Diego
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Upland
country: United States
facility: Inland Rheumatology & Osteoporosis Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Danbury
country: United States
facility: Clinical Research Center of CT/NY
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Baytown
country: United States
facility: Accurate Clinical Management
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Fort Bend Clinical Research, LLC
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Caba
country: Argentina
facility: DOM- Centro de Reumatologia
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro Privado de Medicina Familiar / Mindout Research
state: Buenos Aires
city: Caba
country: Argentina
facility: APRILLUS Asistencia E Investigacion de Arcis Salud
state: Ciudad Autónoma De Buenos Aire
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano
state: Ciudad Autónoma De Buenos Aire
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Hospital J. M. Ramos Mejía
city: Córdoba
country: Argentina
facility: Hospital Córdoba
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Ostrava
country: Czechia
facility: INREA s.r.o.
state: Ostrava Město
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
state: Praha, Hlavní Mešto
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universtitätsklinikum Essen AöR
state: North Rhine-Westphalia
city: Bad Bramstedt
country: Germany
facility: Klinikum Bad Bramstedt GmbH
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
state: Békés
city: Budapest
country: Hungary
facility: Qualiclinic
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
city: Hyderabad
country: India
facility: Krishna Institute of Medical Science
state: Andhra Pradesh
city: Visakhapatanam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Amber Clinic
state: Gujarat
city: Ahmedabad
country: India
facility: Swastik Rheumatology Clinic
state: Gujarat
city: Hubli
country: India
facility: Sushruta Multispeciality Hospital & Research Centre
state: Karnataka
city: Aurangabad
country: India
facility: Government Medical College (GMC) Aurangabad
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College
state: Maharashtra
city: Nagpur
country: India
facility: Jasleen Hospital
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences - Nagpur
state: Maharashtra
city: Pune
country: India
facility: Sancheti Institute for Orthopaedics & Rehabilitation
state: Maharashtra
city: Pune
country: India
facility: Center for Rheumatic Diseases
state: Maharashtra
city: Pune
country: India
facility: Sancheti HealthCare Academy
state: Maharashtra
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Nagoya
country: Japan
facility: Kojunkai Daido Clinic
state: Aichi
city: Kitakyushu
country: Japan
facility: University of Occupational and Enviromental Health
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Chiba
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Daini Osaka Police Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Keio university hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul, Korea
city: Mexicali
country: Mexico
facility: Centro Medico del Angel
state: Baja California
city: Torreon
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Mexico City
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Clinica para el Diagnostico y Tratamiento de la Enfermedades
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.
state: Jalisco
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Bialystok
country: Poland
facility: Nova Reuma Społka Partnerska
state: Podlaskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy
city: Bytom
country: Poland
facility: Nzoz Bif-Med
state: Śląskie
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico Caguas
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
state: Brașov
city: Bucuresti
country: Romania
facility: SC Centrul Medical Sana SRL
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf Maria Bucuresti
city: Galati
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
city: Petrozavodsk
country: Russian Federation
facility: Karelia Republican Hospital V.A. Baranova
state: Kareliya, Respublika
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital Number 15
state: Moskva
city: Moscow
country: Russian Federation
facility: V.A. Nasonova Research Institute of Rheumatology
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Cardiology Dispensary
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung Branch
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Kharkiv
country: Ukraine
facility: Regional Clinical Hospital Center for Emergency medical care
city: Kyiv
country: Ukraine
facility: Edelweiss Medics LLC
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Odesa
country: Ukraine
facility: Multifield Medical Center of Odesa NMU (University Clinic#1)
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Regional Clinical Hospital
city: Zaporizhzhia
country: Ukraine
facility: Regional Clinical Hospital of Zaporizhzhia
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: