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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04433585




Registration number
NCT04433585
Ethics application status
Date submitted
15/06/2020
Date registered
16/06/2020
Date last updated
5/05/2021

Titles & IDs
Public title
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
Secondary ID [1] 0 0
J1P-MC-KFAJ
Secondary ID [2] 0 0
17422
Universal Trial Number (UTN)
Trial acronym
ISLAND-SLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3471851
Treatment: Drugs - Placebo

Experimental: LY3471851 High Dose - LY3471851 administered subcutaneously (SC).

Experimental: LY3471851 Mid Dose - LY3471851 administered SC.

Experimental: LY3471851 Low Dose - LY3471851 administered SC

Placebo Comparator: Placebo - Placebo administered SC.


Treatment: Drugs: LY3471851
Administered SC

Treatment: Drugs: Placebo
Administered SC

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Achieve a =4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score - Percentage of Participants who Achieve a =4 Point Reduction in SLEDAI-2K Score
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants who Achieve British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response - Percentage of Participants who Achieve BICLA Response
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response - Percentage of Participants who Achieve SRI-4 Response
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) - Percentage of Participants who Achieve LLDAS
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851 - PK: Ctrough of LY3471851
Timepoint [4] 0 0
Week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
The Rheumatology Research Unit Sunshine Coast - Maroochydore
Recruitment hospital [2] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aire
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Argentina
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Tucumán
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Cordoba
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Argentina
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San Juan
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Canada
State/province [20] 0 0
Alberta
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Canada
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Newfoundland and Labrador
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha, Hlavní MeŇ°to
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Czechia
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Ostrava
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Germany
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Baden-Württemberg
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Germany
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Nordrhein-Westfalen
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Germany
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North Rhine-Westphalia
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Germany
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Schleswig-Holstein
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Germany
State/province [28] 0 0
Kiel
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Germany
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Köln
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Hungary
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Bekes
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Hungary
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Budapest
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Hungary
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Debrecen
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India
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Andhra Pradesh
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India
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Delhi
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Miyagi
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Japan
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Nagano
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Japan
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Nagasaki
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Japan
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Tokyo
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Japan
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Okayama
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Japan
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Osaka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Korea
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Korea, Republic of
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Seoul, Korea
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Mexico
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Baja California
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Coahuila
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Distrito Federal
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Mexico
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Jalisco
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Poland
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Malopolskie
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Mazowieckie
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Podlaskie
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Bydgoszcz
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Poland
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Slaskie
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Puerto Rico
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Caguas'
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Puerto Rico
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San Juan
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Romania
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Brasov
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Romania
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Bucuresti
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Romania
State/province [68] 0 0
Galati
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Russian Federation
State/province [69] 0 0
Moscow
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Russian Federation
State/province [70] 0 0
Petrozavodsk
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Russian Federation
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Ryazan
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
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Spain
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Sevilla
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung City
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Taichung
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Taiwan
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Taipei City
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Odesa
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Nektar Therapeutics
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04433585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiples sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04433585