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Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.
This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-519 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in B Cells in Blood | Change from baseline in B cells in blood. | Up to 365 Days |
| Maximum Plasma Concentration (Cmax) of ABBV-519. | Cmax of ABBV-519 | Up to 85 Days |
| Time to Cmax (Tmax) of ABBV-519 | Tmax of ABBV-519 | Up to 85 Days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-519 | t1/2 of ABBV-519 | Up to 85 Days |
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519 | AUCt of ABBV-519 | Up to 85 Days |
| Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519 | Percentage of participants with detection of ADAs for ABBV-519 | Up to 169 Days |
| Number of Participants with Adverse Events (AEs) | 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. | Up to 425 Days |
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Inclusion Criteria:
Key Inclusion Criteria:
Inclusion Criteria for SLE Participants:
Inclusion Criteria for RA Participants:
Exclusion Criteria:
Key Exclusion Criteria:
Exclusion for SLE Participants:
Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).
- Unstable or progressive glomerulonephritis (active class III or IV).
SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.
Exclusion for RA Participants:
-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group /ID# 278677 | Recruiting | Anniston | Alabama | 36207 | United States | |
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| ABBV-519 | Drug | Subcutaneous (SC) Injection |
|
| UCLA Health West Medical Campus /ID# 282811 |
| Withdrawn |
| Los Angeles |
| California |
| 90095 |
| United States |
| Solace Research /ID# 279155 | Recruiting | Tustin | California | 92780 | United States |
| Clinical Research Of West Florida - Phase I Unit /ID# 279292 | Recruiting | Clearwater | Florida | 33765 | United States |
| Finlay Medical Research - Greenacres /ID# 278380 | Recruiting | Greenacres City | Florida | 33467 | United States |
| Clinical Research of Osceola /ID# 278374 | Recruiting | Kissimmee | Florida | 34741 | United States |
| Discovery Health Research Center /ID# 279691 | Recruiting | Plantation | Florida | 33317 | United States |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130 | Recruiting | Tampa | Florida | 33606 | United States |
| Advanced Quality Medical Research /ID# 279147 | Recruiting | Orland Park | Illinois | 60462 | United States |
| Epic Medical Research /ID# 279180 | Recruiting | Red Oak | Texas | 75154 | United States |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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