Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04433585 | A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) | PHASE2 | COMPLETED | 291 | — | — | Aug 19, 2020 | Feb 16, 2023 | Apr 23, 2024 | 112 | United States, Argentina +17 |
| NCT03556007 | A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE) | PHASE1 | COMPLETED | 48 | — | — | Apr 18, 2018 | Aug 29, 2019 | Nov 18, 2023 | 14 | United States |
Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
Safety and tolerability of LY3471851 as assessed through collection of adverse events, serious adverse events, change in vital signs (body temperature, blood pressure, heart rate, rate of breathing and oxygen in blood); electrocardiograms (ECG); laboratory evaluations (hematology, chemistry, liver function and urine analysis).
| Arm | Type | Description |
|---|---|---|
| LY3471851 High Dose | EXPERIMENTAL | LY3471851 administered subcutaneously (SC). |
| LY3471851 Mid Dose | EXPERIMENTAL | LY3471851 administered SC. |
| LY3471851 Low Dose | EXPERIMENTAL | LY3471851 administered SC |
| Placebo | PLACEBO_COMPARATOR | Placebo administered SC. |
| Cohort 1 - 3 μg/kg LY3471851 | EXPERIMENTAL | Participants received 3 microgram per kilogram (μg/kg) of LY3471851 or placebo on days 1, 15 and 29 by subcutaneous (SC) injection. |
| Cohort 1 - 6 μg/kg LY3471851 | EXPERIMENTAL | Participants received 6 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. |
| Cohort 1 - 12 μg/kg LY3471851 | EXPERIMENTAL | Participants received 12 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. |
| Cohort 1 - 24 μg/kg LY3471851 | EXPERIMENTAL | Participants received 24 μg/kg of LY3471851 or placebo on days 1, 15 and 29 by SC injection. |
| Name | Type | Description |
|---|---|---|
| LY3471851 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
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) criter...