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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT04433585

Run by

Nektar Therapeutics

People needed

291

Starts

2020-08-19

Expected to finish

2023-02-16

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hanyang University Medical Center — Seoul, Korea, South Korea
• Seoul National University Hospital — Seoul, Seoul, Korea, South Korea
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Quiron Infanta Luisa — Seville, Spain
• Chang Gung Memorial Hospital - Kaohsiung Branch — Kaohsiung City, Taiwan
• China Medical University Hospital — Taichung, Taiwan
• Taichung Veterans General Hospital — Taichung, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• Regional Clinical Hospital Center for Emergency medical care — Kharkiv, Ukraine
• Edelweiss Medics LLC — Kyiv, Ukraine
• Kyiv City Clinical Hospital #3 — Kyiv, Ukraine
• Multifield Medical Center of Odesa NMU (University Clinic#1) — Odesa, Ukraine
• Vinnytsya Regional Clinical Hospital — Vinnytsia, Ukraine
• Regional Clinical Hospital of Zaporizhzhia — Zaporizhzhya, Ukraine
• University of California - San Diego — La Jolla, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Stanford University Hospital — Stanford, California, United States
• Inland Rheumatology & Osteoporosis Medical Group — Upland, California, United States
• University of Colorado School of Medicine — Aurora, Colorado, United States
• Clinical Research Center of CT/NY — Danbury, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• University of Miami School of Medicine — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Kyung Hee University Hospital — Seoul, Korea, South Korea

Full record on ClinicalTrials.gov

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