Intravenous ABBV-319 for adults with SLE or Sjögren's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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
• Advanced Quality Medical Research /ID# 278462
  Orland Park, Illinois, United States Recruiting
• Private Practice - Dr. Ramesh C. Gupta /ID# 275826
  Memphis, Tennessee, United States Recruiting
• Integrative Rheumatology of South Texas - Harlingen /ID# 276458
  Harlingen, Texas, United States Recruiting
• Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692
  Strasbourg, Alsace, France Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of anifrolumab on arterial inflammation in SLE patients

  This study tests whether anifrolumab can reduce blood vessel inflammation in people with active systemic lupus erythematosus.

  Recruiting University of Cambridge · Cambridge, Cambridgeshire · NCT07913919

• Home urine testing for people with lupus

  Participants with lupus will try weekly home urine tests in addition to usual care to see if this helps monitor kidney health over a year.

  Recruiting NYU Langone Health · New York, New York · NCT07823478

• CR-402 treatment for refractory autoimmune disease

  This study tests CRT-402, a CD19-targeted CAR-T therapy, in adults with active, treatment-resistant autoimmune diseases like SLE, systemic sclerosis, and inflammatory myopathy to see if it is safe and capable of helping control disease.

  Recruiting Phase 1/2 Myeloid Therapeutics · Nedlands, Western Australia · NCT07778446

• ATG-201 in adults with autoimmune diseases

  This early, open-label study tests ATG-201 in adults with autoimmune diseases to see if it is safe and tolerable, and to get initial clues about how the body handles the drug and its effects.

  Recruiting Phase 1 Antengene Corporation · Bengbu, Anhui and 21 other locations · NCT07732309

• Biomarker tests in adults with lupus to see how kidney disease changes over time

  Researchers will follow adults with lupus to see if blood and urine biomarkers can predict kidney involvement, flares, and treatment responses during routine care.

  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07666711

• Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia

  This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.

  Recruiting Phase 2/3 Chinese SLE Treatment And Research Group · Beijing, Beijing Municipality · NCT07657793

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.