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...
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ABBV-519 is an investigational small molecule drug being developed by AbbVie Inc. for immunology indications, including systemic lupus erythematosus. It is in Phase 1 clinical development and is not approved for any use. It is being studied as both an intravenous infusion and a subcutaneous injection in adults.
ABBV-519 is being studied for the treatment of systemic lupus erythematosus and rheumatoid arthritis in adults. It is an investigational therapy and has not been approved for these or any other indications. Clinical testing is at the Phase 1 stage, which primarily assesses safety, tolerability and how the drug moves through the body.
ABBV-519 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug in immunology indications, including systemic lupus erythematosus and rheumatoid arthritis.
ABBV-519 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting, and no trials have been completed. Because it remains investigational, ABBV-519 is not FDA approved for any indication, and its safety and efficacy have not been established.
ABBV-519 is being evaluated in the Phase 1 trial NCT07607964, titled a study to assess adverse events, how the drug moves through the body and effectiveness of intravenous infusions and subcutaneous injections of ABBV-519 in adult participants with systemic lupus erythematosus or rheumatoid arthritis. The trial is recruiting and plans to enroll 30 participants in the United States and Japan.