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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT04433585
• Date of registration: 15/06/2020
• Prospective Registration: Yes
• Primary sponsor: Nektar Therapeutics
• Public title: A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) ISLAND-SLE
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus
• Date of first enrolment: August 19, 2020
• Target sample size: 291
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04433585
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Canada, Czechia, Germany, Hungary, India, Israel, Japan, Korea, Republic of, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Nektar Therapeutics

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: LY3471851

Primary Outcome(s)

Percentage of Participants who Achieve a =4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score [Time Frame: Week 24]

Secondary Outcome(s)

Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851 [Time Frame: Week 24]

Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response [Time Frame: Week 24]

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 Lupus Low Disease Activity State (LLDAS) [Time Frame: Week 24]

Secondary ID(s)

17422

J1P-MC-KFAJ

2019-003323-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company