Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-519 · 1 trial · 2 indications
Change from baseline in B cells in blood.
Cmax of ABBV-519
Tmax of ABBV-519
t1/2 of ABBV-519
AUCt of ABBV-519
Percentage of participants with detection of ADAs for ABBV-519
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Group 1: Dose A | EXPERIMENTAL | Participants will receive a single intravenous (IV) dose of ABBV-519 |
| Group 2: Dose B | EXPERIMENTAL | Participants will receive a single intravenous (IV) dose of ABBV-519 |
| Group 3: Dose C | EXPERIMENTAL | Participants will receive a single intravenous (IV) dose of ABBV-519 |
| Group 4: Dose D | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of ABBV-519 |
| Group 5: Dose E | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of ABBV-519 |
| Name | Type | Description |
|---|---|---|
| ABBV-519 | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: Key Inclusion Criteria: * Individuals between 18 and 75 years of age inclusive at the time of Screening. * Minimum baseline B-cell count of 50 cells/mcL. Inclusion Criteria for SLE Participants: * Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification crit...
Top 20 of 32 competitors
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| 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 |
ABBV-519 is an investigational small molecule being developed for systemic lupus erythematosus (SLE). It is also being studied in rheumatoid arthritis (RA). The drug is administered by intravenous infusion or subcutaneous injection and is currently in Phase 1 clinical development.
ABBV-519 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting a Phase 1 clinical trial of the drug in adult participants with systemic lupus erythematosus or rheumatoid arthritis.
ABBV-519 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study is currently recruiting participants to assess adverse events, how the drug moves through the body, and its effectiveness.
ABBV-519 is being studied in a Phase 1 clinical trial with the identifier NCT07607964. The study is recruiting 30 adult participants with systemic lupus erythematosus or rheumatoid arthritis in the United States. The trial is controlled but not randomized or double-blinded.
ABBV-519 is administered by intravenous infusion or subcutaneous injection. The Phase 1 clinical trial is evaluating both routes of administration in adult participants with systemic lupus erythematosus or rheumatoid arthritis.