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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07607964 | 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 (SLE) or Rheumatoid Arthritis (RA) | PHASE1 | RECRUITING | 30 | — | — | May 28, 2026 | Jan 1, 2029 | Jun 2, 2026 | 5 | United States |
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...