Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. 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 and Rheumatoid arthritis (RA) is a long-lasting autoimmune disease that causes the body's immune system to attack itself. RA targets the body's joints, causing inflammation (swelling, pain, and redness). ABBV-319 exhibits potential B cell depletion in SLE, SjD and RA 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, SjD and RA. ABBV-319 is an investigational drug being developed for the treatment of SLE , SjD and RA. Participants are placed in 1 of 8 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE, SjD or RA. Around 48 adult participants with SLE, SjD or RA will be enrolled at approximately up to 17 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Intravenous (IV) Infusion
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239
Avon Park, Florida, United States
NOT_YET_RECRUITINGClinical Research Of West Florida - Phase I Unit /ID# 275834
Clearwater, Florida, United States
NOT_YET_RECRUITINGLife Clinical Trials - Colonial Drive - Margate /ID# 276050
Margate, Florida, United States
RECRUITINGClinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, Florida, United States
RECRUITINGAdvanced Quality Medical Research /ID# 278462
Orland Park, Illinois, United States
RECRUITINGPrivate Practice - Dr. Ramesh C. Gupta /ID# 275826
Memphis, Tennessee, United States
RECRUITINGIntegrative Rheumatology of South Texas - Harlingen /ID# 276458
Harlingen, Texas, United States
RECRUITINGLes Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692
Strasbourg, Alsace, France
RECRUITINGCHU de Montpellier - Hopital Lapeyronie /ID# 279892
Montpellier, Herault, France
RECRUITINGAmsterdam University Medical Center /ID# 274286
Amsterdam, North Holland, Netherlands
RECRUITING...and 1 more locations
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.
Time frame: 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.
Time frame: Up to approximately 400 days
Maximum Plasma Concentration (Cmax) of ABBV-319
Cmax of ABBV-319.
Time frame: Up to approximately 400 days
Time to Cmax (Tmax) of ABBV-319
Tmax of ABBV-319.
Time frame: Up to approximately 400 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
t1/2 of ABBV-319.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 400 days
Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319
Percentage of participants with detection of nAbs for ABBV-319.
Time frame: Up to approximately 400 days
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