Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3471851 · 8 trials · 4 indications
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).
PK: Cmax of LY3471851
PK: AUC of LY3471851
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
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. |
| LY3471851 (Test formulation) | EXPERIMENTAL | LY3471851 administered subcutaneously (SC). |
| LY3471851 (Test) + Levocetirizine | EXPERIMENTAL | LY3471851 administered SC in combination with levocetirizine given orally. |
| LY3471851 (Reference formulation) | ACTIVE_COMPARATOR | LY3471851 administered SC. |
| LY3471851 (Abdomen) | EXPERIMENTAL | LY3471851 administered subcutaneously (SC) into the abdomen. |
| LY3471851 (Thigh) | EXPERIMENTAL | LY3471851 administered SC into the thigh. |
| 10 µg/kg LY3471851 | ACTIVE_COMPARATOR | Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| 12 µg/kg LY3471851 | ACTIVE_COMPARATOR | Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| 24 µg/kg LY3471851 | ACTIVE_COMPARATOR | Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| Cohort 1 - 10 (Microgram Per Kilogram) μg/kg LY3471851 | EXPERIMENTAL | Participants received 10 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks. |
| Cohort 2 - 24 μg/kg LY3471851 | EXPERIMENTAL | Participants received 24 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks. |
| LY3471851 | EXPERIMENTAL | Participants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (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 |
| Levocetirizine | DRUG | Administered orally. |
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...
Top 20 of 32 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Biogen Inc. | BIIB | 5 | PHASE3 | Litifilimab |
| Bristol-Myers Squibb Company | BMY | 7 | PHASE3 | Deucravacitinib |
| Viatris, Inc. | VTRS | 5 | PHASE3 | Cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE2 | Obexelimab |
| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
| Fate Therapeutics, Inc. | FATE | 2 | PHASE2 | FT819 |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
| Cartesian Therapeutics, Inc. | RNAC | 2 | PHASE2 | Descartes-08 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-1045 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363, Fludarabine, Cyclophosphamide |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
LY3471851 is an investigational small molecule being studied for the treatment of psoriasis, atopic dermatitis, and systemic lupus erythematosus. It has also been evaluated in healthy participants to assess its safety and tolerability. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
LY3471851 is being developed by Nektar Therapeutics, a biopharmaceutical company listed on NASDAQ under the ticker symbol NKTR. The drug is also known as NKTR-358, as referenced in some clinical trial titles. Nektar is conducting Phase 1 studies to evaluate the drug's safety and efficacy.
LY3471851 is in Phase 1 clinical development. All four clinical trials for this drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval. It is being studied for psoriasis, atopic dermatitis, and systemic lupus erythematosus.
LY3471851 has been studied in four completed Phase 1 clinical trials. These include NCT04119557 in participants with psoriasis, NCT04133116 in healthy participants, NCT04380324 in healthy participants, and NCT05565729 in healthy participants. All trials were conducted in the United States and have been completed.
Yes, LY3471851 is the same drug as NKTR-358. One of the clinical trials, NCT04380324, is titled 'A Study of NKTR-358 (LY3471851) in Healthy Participants,' confirming that both names refer to the same investigational compound. The drug is being developed by Nektar Therapeutics.
LY3471851 is a small molecule being developed by Nektar Therapeutics. The specific molecular target or mechanism of action has not been disclosed in the available clinical trial information. The drug is being studied for its potential effects in psoriasis, atopic dermatitis, and systemic lupus erythematosus.