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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 : Completed
First Posted : June 16, 2020
Results First Posted : April 23, 2024
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Nektar Therapeutics

Study Description
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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).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: LY3471851 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
Actual Study Start Date : August 19, 2020
Actual Primary Completion Date : January 10, 2023
Actual Study Completion Date : February 16, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3471851 High Dose
LY3471851 administered subcutaneously (SC).
 Drug: LY3471851
Administered SC
Other Names:
  • Rezpegaldesleukin
  • REZPEG
  • NKTR-358
Experimental: LY3471851 Mid Dose
LY3471851 administered SC.
 Drug: LY3471851
Administered SC
Other Names:
  • Rezpegaldesleukin
  • REZPEG
  • NKTR-358
Experimental: LY3471851 Low Dose
LY3471851 administered SC
 Drug: LY3471851
Administered SC
Other Names:
  • Rezpegaldesleukin
  • REZPEG
  • NKTR-358
Placebo Comparator: Placebo
Placebo administered SC.
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24. [ Time Frame: 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).

  2. Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24 [ Time Frame: 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.

  3. Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24 [ Time Frame: 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.

  4. Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851 [ Time Frame: Week 24 ]
    LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433585


Locations
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Sponsors and Collaborators
Nektar Therapeutics
Eli Lilly and Company
Investigators
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Study Director: Study Director Nektar Therapeutics
  Study Documents (Full-Text)

Documents provided by Nektar Therapeutics:
Study Protocol  [PDF] August 19, 2020
Statistical Analysis Plan  [PDF] January 31, 2023

More Information
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Additional Information:

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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT04433585    
Other Study ID Numbers: 17422
J1P-MC-KFAJ ( Other Identifier: Eli Lilly and Company )
2019-003323-38 ( EudraCT Number )
First Posted: June 16, 2020    Key Record Dates
Results First Posted: April 23, 2024
Last Update Posted: April 23, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nektar Therapeutics:
T regulatory cells (Tregs)
Interleukin 2
Interleukin-2
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases