NCT06977724RecruitingPhase 1
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)
A Phase1b, Multiple Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Safety, and Efficacy of ABBV-319 in Subjects With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 12 May 2025
- Start date
- 26 Aug 2025
- Primary completion date
- Mar 2029
- Lead sponsor
- AbbVie
- Diseases
- Sjögren's disease, Lupus (SLE), Rheumatoid arthritis
- NCT number
- NCT06977724
- EU CT number
- 2024-519157-10-00
- EudraCT number
- 2024-519157-10
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 26 Aug 2025 to the primary completion date, Mar 2029
- 11 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of infection as defined in the protocol.
- Any of the medical diseases or disorders listed in the protocol.
- RA-Specific Exclusion Criteria - History of RA overlap syndromes, including but not limited to, SLE, SjD, scleroderma, mixed connective tissue disease, or polymyositis.
Other
- Any clinically significant ECG abnormalities at Screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239 Coordinator of this site? Confirm its status | Avon Park | United States | Not yet recruiting |
| Clinical Research Of West Florida - Phase I Unit /ID# 275834 Coordinator of this site? Confirm its status | Clearwater | United States | Not yet recruiting |
| Integrative Rheumatology of South Texas - Harlingen /ID# 276458 Coordinator of this site? Confirm its status | Harlingen | United States | Recruiting |
| Life Clinical Trials - Colonial Drive - Margate /ID# 276050 Coordinator of this site? Confirm its status | Margate | United States | Recruiting |
| Private Practice - Dr. Ramesh C. Gupta /ID# 275826 Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Advanced Quality Medical Research /ID# 278462 Coordinator of this site? Confirm its status | Orland Park | United States | Recruiting |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.