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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04433585
Recruitment Status : Active, not recruiting
First Posted : June 16, 2020
Last Update Posted : August 10, 2022
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 15, 2020
First Posted Date  ICMJE June 16, 2020
Last Update Posted Date August 10, 2022
Actual Study Start Date  ICMJE August 19, 2020
Estimated Primary Completion Date December 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)		 Percentage of Participants who Achieve a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score [ Time Frame: Week 24 ]
Percentage of Participants who Achieve a ≥4 Point Reduction in SLEDAI-2K Score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • Percentage of Participants who Achieve British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response [ Time Frame: Week 24 ]
    Percentage of Participants who Achieve BICLA Response
  • Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response [ Time Frame: Week 24 ]
    Percentage of Participants who Achieve SRI-4 Response
  • Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 24 ]
    Percentage of Participants who Achieve LLDAS
  • Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851 [ Time Frame: Week 24 ]
    PK: Ctrough of LY3471851
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: LY3471851
    Administered SC
    Other Name: NKTR-358
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: LY3471851 High Dose
    LY3471851 administered subcutaneously (SC).
    Intervention: Drug: LY3471851
  • Experimental: LY3471851 Mid Dose
    LY3471851 administered SC.
    Intervention: Drug: LY3471851
  • Experimental: LY3471851 Low Dose
    LY3471851 administered SC
    Intervention: Drug: LY3471851
  • Placebo Comparator: Placebo
    Placebo administered SC.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)		 280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 23, 2023
Estimated Primary Completion Date December 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Czechia,   Germany,   Hungary,   India,   Israel,   Japan,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT04433585
Other Study ID Numbers  ICMJE 17422
J1P-MC-KFAJ ( Other Identifier: Eli Lilly and Company )
2019-003323-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Nektar Therapeutics
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP