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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: LY3471851 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Estimated Primary Completion Date :||December 23, 2022|
|Estimated Study Completion Date :||March 23, 2023|
Experimental: LY3471851 High Dose
LY3471851 administered subcutaneously (SC).
Other Name: NKTR-358
Experimental: LY3471851 Mid Dose
LY3471851 administered SC.
Other Name: NKTR-358
Experimental: LY3471851 Low Dose
LY3471851 administered SC
Other Name: NKTR-358
Placebo Comparator: Placebo
Placebo administered SC.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
J1P-MC-KFAJ ( Other Identifier: Eli Lilly and Company )
2019-003323-38 ( EudraCT Number )
|First Posted:||June 16, 2020 Key Record Dates|
|Last Update Posted:||August 10, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|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.|
Statistical Analysis Plan (SAP)
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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
T regulatory cells (Tregs)
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases