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A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)

RecruitingPhase 1Ages 18 Years - 75 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 positive antinuclear antibody (ANA) \>= 1:80 drawn at Screening. * SLE Population - Anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome Ag A (SSA) Abs above the upper limit of normal (ULN). * Sjogren's Disease (SjD) Population - Primary diagnosis of SjD at least 6 months prior to Screening as defined by the ACR/EULAR 2016 Criteria. * SjD Population - EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) \>= 5 at Screening. * SjD Population - EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) \>= 5 at Screening. * Rheumatoid Arthritis (RA) Population - Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA. * RA Population - Rheumatoid Factor (RF) or ACPA above the ULN at Screening. * RA Population - Confirmation of at least moderate disease activity at Screening, defined by both of the following disease activity criteria: * Presence of at least 6 swollen and 6 tender joints at Screening using the 68 (tender)/66 (swollen) joint count. * hs-CRP โ‰ฅ3 mg/L. Exclusion Criteria: * History of infection as defined in the protocol. * Any of the medical diseases or disorders listed in the protocol. * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the 6 months prior to Screening. * Any planned elective surgery that would impact study procedures or assessments through the completion of the Day 365 assessments. * Any clinically significant ECG abnormalities at Screening. * RA-Specific Exclusion Criteria - History of RA overlap syndromes, including but not limited to, SLE, SjD, scleroderma, mixed connective tissue disease, or polymyositis.
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What it tests

  • ABBV-319
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Where

11 sites
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239
Avon Park, United States
Clinical Research Of West Florida - Phase I Unit /ID# 275834
Clearwater, United States
Life Clinical Trials - Colonial Drive - Margate /ID# 276050
Margate, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, United States
Advanced Quality Medical Research /ID# 278462
Orland Park, United States
Private Practice - Dr. Ramesh C. Gupta /ID# 275826
Memphis, United States
Integrative Rheumatology of South Texas - Harlingen /ID# 276458
Harlingen, United States
Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692
Strasbourg, France

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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