A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
- Registration Number
- NCT04433585
- Lead Sponsor
- Nektar Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3471851 Low Dose LY3471851 LY3471851 administered SC LY3471851 High Dose LY3471851 LY3471851 administered subcutaneously (SC). LY3471851 Mid Dose LY3471851 LY3471851 administered SC. Placebo Placebo Placebo administered SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24 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).
- Secondary Outcome Measures
Name Time Method 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 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).Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24 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.
Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24 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.
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851 Week 24 LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.
Trial Locations
- Locations (112)
Clinical Research Center of CT/NY
🇺🇸Danbury, Connecticut, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Northwell Health
🇺🇸Great Neck, New York, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, 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
Revmatologicky ustav
🇨🇿Praha 2, Praha, Hlavní Mešto, Czechia
Sushruta Multispeciality Hospital & Research Centre
🇮🇳Hubli, Karnataka, India
Amber Clinic
🇮🇳Ahmedabad, Gujarat, India
Inha University Hospital
🇰🇷Incheon, Korea, Korea, Republic of
Clinica para el Diagnostico y Tratamiento de la Enfermedades
🇲🇽Mexico City, Distrito Federal, Mexico
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Universtitätsklinikum Essen AöR
🇩🇪Essen, North Rhine-Westphalia, Germany
Klinikum Bad Bramstedt GmbH
🇩🇪Bad Bramstedt, Schleswig-Holstein, Germany
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Hospital Córdoba
🇦🇷Córdoba, Argentina
Krishna Institute of Medical Science
🇮🇳Hyderabad, Andhra Pradesh, India
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Universitätsklinikum Köln
🇩🇪Köln, Germany
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
DOM- Centro de Reumatologia
🇦🇷Caba, Buenos Aires, Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
🇦🇷San Juan, Argentina
Rheumazentrum Ruhrgebiet
🇩🇪Herne, Nordrhein-Westfalen, Germany
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Universitätsklinikum Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Qualiclinic
🇭🇺Budapest, Hungary
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
NECCR PrimaCare Research
🇺🇸Fall River, Massachusetts, United States
Clinica Adventista Belgrano
🇦🇷Caba, Ciudad Autónoma De Buenos Aire, 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
Hospital J. M. Ramos Mejía
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
Center for Rheumatic Diseases
🇮🇳Pune, Maharashtra, India
All India Institute of Medical Sciences - Nagpur
🇮🇳Nagpur, Maharashtra, India
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Nagasaki, Japan
Sancheti HealthCare Academy
🇮🇳Pune, Maharashtra, India
University of Calgary
🇨🇦Calgary, Alberta, Canada
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
University of Occupational and Enviromental Health
🇯🇵Kitakyushu, Fukuoka, Japan
Daini Osaka Police Hospital
🇯🇵Osaka, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
Seoul National University Hospital
🇰🇷Seoul, Seoul, Korea, Korea, Republic of
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Moscow City Clinical Hospital Number 15
🇷🇺Moscow, Moskva, Russian Federation
Chang Gung Memorial Hospital - Kaohsiung Branch
🇨🇳Kaohsiung City, Taiwan
Vinnytsya Regional Clinical Hospital
🇺🇦Vinnytsya, Ukraine
Sancheti Institute for Orthopaedics & Rehabilitation
🇮🇳Pune, Maharashtra, India
Jasleen Hospital
🇮🇳Nagpur, Maharashtra, India
V.A. Nasonova Research Institute of Rheumatology
🇷🇺Moscow, Russian Federation
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
RM Pharma Specialists S.A. de C.V.
🇲🇽Mexico City, Distrito Federal, Mexico
SC Centrul Medical Sana SRL
🇷🇴Bucuresti, Romania
Karelia Republican Hospital V.A. Baranova
🇷🇺Petrozavodsk, Kareliya, Respublika, Russian Federation
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
🇷🇴Galati, Romania
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Kyiv City Clinical Hospital #3
🇺🇦Kyiv, Ukraine
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Korea, Republic of
Spitalul Clinic Sf Maria Bucuresti
🇷🇴Bucuresti, Romania
Edelweiss Medics LLC
🇺🇦Kyiv, Ukraine
Centro Integral en Reumatologia
🇲🇽Guadalajara, Jalisco, Mexico
Hanyang University Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Nova Reuma Społka Partnerska
🇵🇱Bialystok, Podlaskie, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Nzoz Bif-Med
🇵🇱Bytom, Śląskie, Poland
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
C.M.D.T.A. Neomed
🇷🇴Brasov, Brașov, Romania
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Regional Clinical Hospital Center for Emergency medical care
🇺🇦Kharkiv, Ukraine
Multifield Medical Center of Odesa NMU (University Clinic#1)
🇺🇦Odesa, Ukraine
Desert Medical Advances
🇺🇸Palm Desert, California, United States
University of California - San Diego
🇺🇸La Jolla, 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
Paramount Medical Research
🇺🇸Middleburg Heights, Ohio, United States
NYU Langone
🇺🇸New York, New York, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Accurate Clinical Management
🇺🇸Baytown, Texas, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
INREA s.r.o.
🇨🇿Ostrava, Ostrava Město, Czechia
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
🇭🇺Gyula, Békés, Hungary
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
🇭🇺Debrecen, Hungary
King George Hospital
🇮🇳Visakhapatanam, Andhra Pradesh, India
Swastik Rheumatology Clinic
🇮🇳Ahmedabad, Gujarat, India
Government Medical College (GMC) Aurangabad
🇮🇳Aurangabad, Maharashtra, India
Government Medical College
🇮🇳Nagpur, Maharashtra, India
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Kojunkai Daido Clinic
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization Chibahigashi National Hospital
🇯🇵Chiba, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Keio university hospital
🇯🇵Tokyo, Japan
Centro Medico del Angel
🇲🇽Mexicali, Baja California, Mexico
CIMAB SA de CV
🇲🇽Torreon, Coahuila, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
🇲🇽Guadalajara, Jalisco, Mexico
Centro Reumatologico Caguas
🇵🇷Caguas, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Mindful Medical Research
🇵🇷San Juan, Puerto Rico
Ryazan Regional Clinical Cardiology Dispensary
🇷🇺Ryazan, Russian Federation
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Spain
China Medical University Hospital
🇨🇳Taichung City, Taiwan
Regional Clinical Hospital of Zaporizhzhia
🇺🇦Zaporizhzhia, Ukraine