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 an investigational small molecule being studied for Dry Eye Syndrome and Diffuse Large B-Cell Lymphoma (DLBCL). It is also being evaluated in clinical trials for related conditions including Chronic Lymphocytic Leukemia, Follicular Lymphoma, Systemic Lupus Erythematosus, Sjogren's Disease, and Rheumatoid Arthritis. The drug is 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. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in adult participants.
ABBV-319 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies are ongoing: one in relapsed or refractory B-cell malignancies and another in autoimmune conditions including Dry Eye Syndrome.
ABBV-319 is being studied in two Phase 1 clinical trials. NCT05512390 is evaluating the drug in adults with relapsed or refractory Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, or Chronic Lymphocytic Leukemia across the United States, Australia, Canada, Israel, South Korea, and Spain. NCT06977724 is studying it in adults with Systemic Lupus Erythematosus, Sjogren's Disease, and Rheumatoid Arthritis in the United States, France, and the Netherlands.
ABBV-319 is the sole name provided for this investigational drug. No alternative names or brand names have been associated with it in the available clinical trial information. It is identified only by its development code ABBV-319 in the studies registered on ClinicalTrials.gov.