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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519157-10 | Other Identifier | EU CT | |
| 2024-519157-10-00 | EU Trial (CTIS) Number |
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Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity and Sjorgren's disease (SjD) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. ABBV-319 exhibits potential B cell depletion in SLE and SjD which are characterized by B cell hyperactivity. The purpose of this study is to assess the pharmacokinetics, safety, and efficacy of ABBV-319 in adult participants with SLE or SjD.
ABBV-319 is an investigational drug being developed for the treatment of SLE and SjD. Participants are placed in 1 of 6 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE or SjD. Around 36 adult participants with SLE or SjD will be enrolled at approximately 10 sites worldwide.
Participants will receive 2 doses of IV ABBV-319 21 days apart and will be followed for up to 343 days.
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 |
|---|---|---|---|
| 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. |
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| ABBV-319 Group 3: SLE Participants | Experimental | SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart. |
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| ABBV-319 Group 4: SLE Participants | Experimental | SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart. |
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| ABBV-319 Group 5: SjD Participants | Experimental | Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
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| ABBV-319 Group 6: SjD Participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-319 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 approximately 400 days |
| Change from Baseline in B Cells in Blood and Tissue | Change from baseline in B cells in blood and tissue. | Up to approximately 400 days |
| Maximum Plasma Concentration (Cmax) of ABBV-319 | Cmax of ABBV-319. | Up to approximately 400 days |
| Time to Cmax (Tmax) of ABBV-319 | Tmax of ABBV-319. | Up to approximately 400 days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 | t1/2 of ABBV-319. | Up to approximately 400 days |
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319 | AUCt of ABBV-319. | Up to approximately 400 days |
| Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319 | Percentage of participants with detection of ADAs for ABBV-319. | Up to approximately 400 days |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Life Clinical Trials - Colonial Drive - Margate /ID# 276050 | Recruiting | Margate | Florida | 33063 | United States | |
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SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
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| Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319 |
Percentage of participants with detection of nAbs for ABBV-319. |
| Up to approximately 400 days |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836 |
| Recruiting |
| Tampa |
| Florida |
| 33606 |
| United States |
| Private Practice - Dr. Ramesh C. Gupta I /ID# 275826 | Recruiting | Memphis | Tennessee | 38119 | United States |
|
| Integrative Rheumatology of South Texas - Harlingen /ID# 276458 | Recruiting | Harlingen | Texas | 78550 | United States |
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| Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692 | Recruiting | Strasbourg | Alsace | 67200 | France |
| Amsterdam UMC, locatie AMC /ID# 274286 | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 273398 | Recruiting | Utrecht | 3584 CX | Netherlands |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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