What this study is
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.
What's being tested
- ABBV-319
Intervention · DRUG
Intravenous (IV) Infusion
Study details
- Official title
- 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)
- Sponsor
- AbbVie
- Conditions
- Dry Eye Syndrome · Systemic Lupus Erythematosus
- Enrolling
- 36 people
- Starts
- 2025-08-26
- Est. completion
- 2029-03
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (11)
11 openHighlands 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
- Site Coordinator · Contact901-681-9670
RecruitingIntegrative Rheumatology of South Texas - Harlingen /ID# 276458
Harlingen, Texas, United States
- Site Coordinator · Contact956-423-1112
Recruiting
4 sites outside the US
Les 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
RecruitingUniversitair Medisch Centrum Utrecht /ID# 273398
Utrecht, Netherlands
Recruiting
Study team
Sponsor
AbbVie
Study ID M25-433
Study director
ABBVIE INC.
AbbVie
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.