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Clinical Trials List

Protocol NumberJ1P-MC-KFAJ

NCT Number(ClinicalTrials.gov Identfier)NCT04433585

Completed

2020-07-13 - 2024-04-30

Phase II

Recruiting4

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

Trial Applicant

ELI LILLY AND COMPANY(TAIWAN), INC.
Sponsor

Eli Lilly and Company
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 邱文燦 Division of Rheumatology

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Joung-Liang Lan 風濕免疫科

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator WEN-NAN HUANG Division of Rheumatology

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator SONG-CHOU HSIEH Division of Rheumatology

National Taiwan University Hospital

Co-Principal Investigator

KO-JEN LI Division of Rheumatology
CHENG-HAN WU Division of Rheumatology
呂政勳 Division of Rheumatology
CHIEH-YU SHEN Division of Rheumatology
郭佑民 Division of Rheumatology

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Systemic Lupus Erythematosus

Objectives

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). 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.

Test Drug

LY3471851

Active Ingredient

LY3471851

Dosage Form

Vial

Dosage

0.5

Endpoints

Primary Outcome Measures :
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

Secondary Outcome Measures :
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

Inclution 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

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.

The Estimated Number of Participants

Taiwan

29 participants
Global

280 participants