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Systemic Lupus ErythematosusPhase 2ISLAND-SLENCT04433585

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

A Phase 2 study testing LY3471851 in people with Systemic Lupus Erythematosus, run by Nektar Therapeutics at 112 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
LY3471851
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
291 participants
Where
112 sitesin 19 countries
Study dates
19 Aug 2020to 16 Feb 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

112 sites in 19 countries.

112 sites in 19 countries

United States23 sites

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

  • Accurate Clinical Management

    Baytown, Texas, 77521

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Clinical Research Center of CT/NY

    Danbury, Connecticut, 06810

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Northwell Health

    Great Neck, New York, 11021

  • Accurate Clinical Research

    Houston, Texas, 77089

  • University of California - San Diego

    La Jolla, California, 92037

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • New Horizon Research Center

    Miami, Florida, 33165 3338

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • NYU Langone

    New York, New York, 10016

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104-5046

  • Desert Medical Advances

    Palm Desert, California, 92260

  • University of Washington Medical Center

    Seattle, Washington, 98195-6422

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Stanford University Hospital

    Stanford, California, 94305

  • Fort Bend Clinical Research, LLC

    Sugar Land, Texas, 77479

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California, 91786

Other trials in United States

India13 sites

  • Amber Clinic

    Ahmedabad, Gujarat, 380015

  • Swastik Rheumatology Clinic

    Ahmedabad, Gujarat, 380054

  • Government Medical College (GMC) Aurangabad

    Chhatrapati Sambhajinagar, Maharashtra, 431001

  • Sushruta Multispeciality Hospital & Research Centre

    Hubli, Karnataka, 580021

  • Krishna Institute of Medical Science

    Hyderabad, Andhra Pradesh, 500003

  • Government Medical College

    Nagpur, Maharashtra, 440003

  • Jasleen Hospital

    Nagpur, Maharashtra, 440012

  • All India Institute of Medical Sciences - Nagpur

    Nagpur, Maharashtra, 441108

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Sancheti Institute for Orthopaedics & Rehabilitation

    Pune, Maharashtra, 41005

  • Center for Rheumatic Diseases

    Pune, Maharashtra, 411001

  • Sancheti HealthCare Academy

    Pune, Maharashtra, 411005

  • King George Hospital

    Visakhapatanam, Andhra Pradesh, 530002

Other trials in India

Japan12 sites

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, 260-8712

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

  • University of Occupational and Enviromental Health

    Kitakyushu, Fukuoka, 807-8556

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

  • Kojunkai Daido Clinic

    Nagoya, Aichi-ken, 4570818

  • Okayama University Hospital

    Okayama, 700-8558

  • Daini Osaka Police Hospital

    Osaka, 543-0042

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Sasebo Chuo Hospital

    Sasebo, Nagasaki, 857-1195

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Keio university hospital

    Tokyo, 160 8582

Other trials in Japan

Argentina8 sites

  • DOM- Centro de Reumatologia

    CABA, Buenos Aires, 1111

  • APRILLUS Asistencia E Investigacion de Arcis Salud

    CABA, Ciudad Autónoma de Buenos Aire, 1406

  • Clinica Adventista Belgrano

    CABA, Ciudad Autónoma de Buenos Aire, C1430EGF

  • Centro Privado de Medicina Familiar / Mindout Research

    Ciudad Autónoma de Buenos Aire, Buenos Aires, 1417

  • Hospital J. M. Ramos Mejía

    Ciudad Autónoma de Buenos Aire, C1221ADC

  • Hospital Córdoba

    Córdoba, 5004

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

    San Juan, J5402DIL

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

Other trials in Argentina

Germany6 sites

  • Klinikum Bad Bramstedt GmbH

    Bad Bramstedt, Schleswig-Holstein, 24576

  • Universitätsklinikum Köln

    Cologne, 50924

  • Universtitätsklinikum Essen AöR

    Essen, North Rhine-Westphalia, 45147

  • Rheumazentrum Ruhrgebiet

    Herne, North Rhine-Westphalia, 44649

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

    Kiel, 24105

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Mexico6 sites

  • Centro Integral en Reumatologia

    Guadalajara, Jalisco, 44160

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco, 44650

  • Centro Medico del Angel

    Mexicali, Estado de Baja California, 21100

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

    Mexico City, Mexico City, 03100

  • Clinica para el Diagnostico y Tratamiento de la Enfermedades

    Mexico City, Mexico City, 06700

  • CIMAB SA de CV

    Torreón, Coahuila, 27000

Other trials in Mexico

Ukraine6 sites

  • Regional Clinical Hospital Center for Emergency medical care

    Kharkiv

  • Edelweiss Medics LLC

    Kyiv, 02002

  • Kyiv City Clinical Hospital #3

    Kyiv

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

    Odesa, 65026

  • Vinnytsya Regional Clinical Hospital

    Vinnytsia, 21018

  • Regional Clinical Hospital of Zaporizhzhia

    Zaporizhzhya, 69600

Other trials in Ukraine

South Korea5 sites

  • Inha University Hospital

    Incheon, Korea, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Kyung Hee University Hospital

    Seoul, Korea, 02447

  • Hanyang University Medical Center

    Seoul, Korea, 04763

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080

Other trials in South Korea

Israel4 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 4428164

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Poland4 sites

  • Nova Reuma Społka Partnerska

    Bialystok, Podlaskie Voivodeship, 15-707

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy

    Bydgoszcz, 85-168

  • Nzoz Bif-Med

    Bytom, Silesian Voivodeship, 41-902

  • MICS Centrum Medyczne Warszawa

    Warsaw, Masovian Voivodeship, 00874

Other trials in Poland

Puerto Rico4 sites

  • Centro Reumatologico Caguas

    Caguas, PR, 00725

  • Latin Clinical Trial Center

    San Juan, PR, 00909

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 00917

  • Mindful Medical Research

    San Juan, PR, 00918

Other trials in Puerto Rico

Romania4 sites

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283

  • SC Centrul Medical Sana SRL

    Bucharest, 011025

  • Spitalul Clinic Sf Maria Bucuresti

    Bucharest, 011172

  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

    Galati, 800578

Other trials in Romania

Russia4 sites

  • Moscow City Clinical Hospital Number 15

    Moscow, Moscow, 111539

  • V.A. Nasonova Research Institute of Rheumatology

    Moscow, 115522

  • Karelia Republican Hospital V.A. Baranova

    Petrozavodsk, Kareliya, Respublika, 185019

  • Ryazan Regional Clinical Cardiology Dispensary

    Ryazan, 390026

Other trials in Russia

Taiwan4 sites

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10048

Other trials in Taiwan

Hungary3 sites

  • Qualiclinic

    Budapest, 1036

  • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

    Debrecen, 4004

  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

    Gyula, Bekes County, 5700

Other trials in Hungary

Czechia2 sites

  • INREA s.r.o.

    Ostrava, Ostrava Město, 70300

  • Revmatologicky ustav

    Prague, Praha, Hlavní Mešto, 12850

Other trials in Czechia

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Quiron Infanta Luisa

    Seville, 41010

Other trials in Spain

Australia1 site

  • Emeritus Research

    Camberwell, Victoria, 3124

Other trials in Australia

Canada1 site

  • University of Calgary

    Calgary, Alberta, T2N 4N1

Other trials in Canada

About this study

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

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).

Read the 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.

Being tested
LY3471851, Placebo
Keywords
T regulatory cells (Tregs), Interleukin 2, Interleukin-2
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3471851Drug

    Also called Rezpegaldesleukin, REZPEG, NKTR-358

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT04433585
Study groupRoleWhat they receive
LY3471851 High DoseExperimentalLY3471851 administered subcutaneously (SC).
Receives: Drug: LY3471851
LY3471851 Mid DoseExperimentalLY3471851 administered SC.
Receives: Drug: LY3471851
LY3471851 Low DoseExperimentalLY3471851 administered SC
Receives: Drug: LY3471851
PlaceboPlacebo comparatorPlacebo administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 24

Secondary outcomes (4)

  1. 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).

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

    Measured: Week 24

  4. 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.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start19 Aug 2020
  3. Primary completion10 Jan 2023
  4. Study completion16 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04433585
Sponsor's protocol ID
17422
Other IDs
J1P-MC-KFAJ, 2019-003323-38, 2019
Acronym
ISLAND-SLE
Status last verified
Mar 2024
First submitted
15 Jun 2020
Last updated
23 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3471851 in people with Systemic Lupus Erythematosus, run by Nektar Therapeutics at 112 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, India, Japan, Argentina, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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