Intravenous ABBV-319 for adults with SLE or Sjögren's disease
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) and Sjogren's Disease (SjD)
This trial will test whether two IV doses of ABBV-319 given 21 days apart are safe, reach expected blood levels, and might help adults with SLE or Sjögren's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 6 sites (Margate, Florida and 5 other locations) |
| Trial ID | NCT06977724 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, interventional, dose-ranging trial enrolling about 36 adults with either systemic lupus erythematosus (SLE) or primary Sjögren's disease (SjD). Participants are assigned to one of six treatment arms that receive different ABBV-319 doses depending on diagnosis, with two intravenous infusions 21 days apart. The study will collect pharmacokinetic (how the drug moves through the body), safety, and early efficacy data and will include scheduled follow-up visits. Sites include multiple centers in the U.S. and additional sites worldwide to monitor responses and adverse events.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of SLE (per 2019 EULAR/ACR criteria with positive ANA and relevant autoantibodies) or primary Sjögren's disease (per 2016 ACR/EULAR) with moderate disease activity are the intended participants.
Not a fit: Patients with active infections, significant comorbidities, or who do not meet the required serologic or disease-activity criteria are unlikely to benefit and may be excluded.
Why it matters
Potential benefit: If successful, ABBV-319 could reduce pathogenic B cell activity and lead to improved systemic and glandular symptoms such as inflammation and dry eyes or mouth.
How similar studies have performed: Other B-cell–targeted therapies (for example, rituximab or belimumab) have shown benefit in subsets of SLE patients and mixed results in Sjögren's, while ABBV-319 is a novel agent with limited prior human outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 - Presence of 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. 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.
Where this trial is running
Margate, Florida and 5 other locations
- 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)
- Amsterdam UMC, locatie AMC /ID# 274286 — Amsterdam, North Holland, Netherlands (Recruiting)
- Universitair Medisch Centrum Utrecht /ID# 273398 — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.