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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04433585
Registration number
NCT04433585
Ethics application status
Date submitted
15/06/2020
Date registered
16/06/2020
Date last updated
23/04/2024
Titles & IDs
Public title
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
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Secondary ID [1]
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J1P-MC-KFAJ
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Secondary ID [2]
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17422
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Universal Trial Number (UTN)
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Trial acronym
ISLAND-SLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved a =4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
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Assessment method [1]
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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).
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.
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Assessment method [1]
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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).
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24
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Assessment method [3]
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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.
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
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Assessment method [4]
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LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.
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Timepoint [4]
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Week 24
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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.
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/02/2023
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Sample size
Target
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Accrual to date
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Final
291
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Emeritus Research - Camberwell
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Recruitment postcode(s) [1]
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3124 - Camberwell
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Recruitment outside Australia
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Zaporizhzhia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Nektar Therapeutics
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Eli Lilly and Company
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04433585
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Study Director
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Address
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Nektar Therapeutics
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04433585
Download to PDF