Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-319 · 2 trials · 5 indications
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.
Change from baseline in B cells in blood and tissue.
Cmax of ABBV-319.
Tmax of ABBV-319.
t1/2 of ABBV-319.
AUCt of ABBV-319.
Percentage of participants with detection of ADAs for ABBV-319.
Percentage of participants with detection of nAbs for ABBV-319.
A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum observed serum concentration of ABBV-319.
Area under the serum concentration versus time curve (AUC) of ABBV-319.
Incidence and concentration of anti-drug antibodies.
| Arm | Type | Description |
|---|---|---|
| ABBV-319 Group 1: SLE Participants | EXPERIMENTAL | Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart. |
| ABBV-319 Group 2: SLE Participants | EXPERIMENTAL | SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart. |
| ABBV-319 Group 3: SLE Participants | EXPERIMENTAL | SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart. |
| ABBV-319 Group 4: SLE Participants | EXPERIMENTAL | SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart. |
| ABBV-319 Group 5: SjD Participants | EXPERIMENTAL | Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
| ABBV-319 Group 6: SjD Participants | EXPERIMENTAL | SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
| ABBV-319 Group 7: RA Participants | EXPERIMENTAL | Rheumatoid Arthritis (RA) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
| ABBV-319 Group 8: RA Participants | EXPERIMENTAL | RA participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
| Dose Escalation ABBV-319 | EXPERIMENTAL | Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the doses of ABBV-319 that will be used in the next phase are determined. |
| (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants | EXPERIMENTAL | Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles. |
| (ABBV-319) Follicular Lymphoma (FL) Participants | EXPERIMENTAL | Participants with R/R FL will receive ABBV-319 in 21-day cycles. |
| (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants | EXPERIMENTAL | Participants with R/R CLL will receive ABBV-319 in 21-day cycles. |
| Name | Type | Description |
|---|---|---|
| ABBV-319 | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: * Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6 months prior to Screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College Of Rheumatology (ACR) classification criteria for SLE and a positiv...
ABBV-319 is being studied for Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Dry Eye Syndrome, Systemic Lupus Erythematosus, and Rheumatoid Arthritis. It is an investigational small molecule in Phase 1 clinical development.
ABBV-319 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.
ABBV-319 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
ABBV-319 is being evaluated in two Phase 1 trials. NCT05512390 is studying the drug in relapsed or refractory Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, and Chronic Lymphocytic Leukemia. NCT06977724 is studying it in Systemic Lupus Erythematosus, Sjogren's Disease, and Rheumatoid Arthritis.
Yes, ABBV-319 is being studied in oncology. One of its Phase 1 trials, NCT05512390, is enrolling adult participants with relapsed or refractory Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, or Chronic Lymphocytic Leukemia.
Yes, ABBV-319 is being studied in autoimmune diseases. Trial NCT06977724 is evaluating the drug in adult participants with Systemic Lupus Erythematosus, Sjogren's Disease, and Rheumatoid Arthritis, and it also lists Dry Eye Syndrome as a condition.