Condition: Dry Eye Syndrome · Systemic Lupus Erythematosus · Sponsor: AbbVie
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.
This description comes directly from the study's public registry record.
ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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| Life Clinical Trials - Colonial Drive - Margate /ID# 276050 | Margate, Florida, United States | Recruiting |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836 | Tampa, Florida, United States | Recruiting |
| Private Practice - Dr. Ramesh C. Gupta I /ID# 275826 | Memphis, Tennessee, United States | Recruiting |
| Integrative Rheumatology of South Texas - Harlingen /ID# 276458 | Harlingen, Texas, United States | Recruiting |
| Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692 | Strasbourg, Alsace, France | Recruiting |
| Amsterdam UMC, locatie AMC /ID# 274286 | Amsterdam, North Holland, Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht /ID# 273398 | Utrecht, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06977724