Phase 2
Completed N=291
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)
Source: ClinicalTrials.gov NCT04433585 ↗Enrolled (actual)
291
Serious AEs
5.5%
Results posted
Apr 2024
Primary outcomePrimary: Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24 — 20; 27; 22; 22 Participants — p=0.309
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24 |
20; 27; 22; 22 | 0.309 |
| SECONDARY Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24. |
12; 26; 18; 18 | 0.131 |
| SECONDARY Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24 |
20; 27; 22; 22 | 0.944 |
| SECONDARY Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24 |
12; 18; 11; 10 | 0.203 |
| SECONDARY Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851 |
214.4; 133.3; 55.9 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04433585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.