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)
Recruiting · NCT06977724 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 ≥3 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.
Where it is running
11 locations listed across 4 US states.
- Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239 - Avon Park, Florida, United States
- Clinical Research Of West Florida - Phase I Unit /ID# 275834 - Clearwater, Florida, United States
- Life Clinical Trials - Colonial Drive - Margate /ID# 276050 - Margate, Florida, United States
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836 - Tampa, Florida, United States
- Advanced Quality Medical Research /ID# 278462 - Orland Park, Illinois, United States
- Private Practice - Dr. Ramesh C. Gupta /ID# 275826 - Memphis, Tennessee, United States
- Integrative Rheumatology of South Texas - Harlingen /ID# 276458 - Harlingen, Texas, United States
- Universitair Medisch Centrum Utrecht /ID# 273398 - Utrecht, Netherlands
- Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692 - Strasbourg, Alsace, France
- CHU de Montpellier - Hopital Lapeyronie /ID# 279892 - Montpellier, Herault, France
- Amsterdam University Medical Center /ID# 274286 - Amsterdam, North Holland, Netherlands