Phase 1 Lupus Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Systemic Lupus Erythematosus (SLE) — a long-term immune system condition — at least 6 months before the screening visit, and a specific blood test at screening shows a positive result at a certain level (ANA ≥ 1:80).
- You have SLE and a blood test shows raised levels of at least one of certain specific proteins linked to the immune system (anti-dsDNA, anti-Smith, anti-RNP, or anti-SSA antibodies) above the normal range.
- You have been diagnosed with Sjögren's Disease (SjD) — a condition that affects moisture-producing glands — as your primary condition, for at least 6 months before the screening visit, based on recognised medical criteria.
- You have Sjögren's Disease and your disease activity score (measured by a standard medical tool called ESSDAI) is 5 or above at screening.
- You have Sjögren's Disease and your personal symptom score (measured by a patient-reported tool called ESSPRI) is 5 or above at screening.
Who may not be able to join:
- You have a history of certain infections as defined in the trial's detailed guidelines (confirm with trial site).
- You have a history of certain medical conditions or disorders listed in the trial's detailed guidelines (confirm with trial site).
- You have had a significant problem with drug or alcohol misuse in the 6 months before the screening visit, based on the doctor's assessment.
- You have any planned non-emergency surgery that could affect your participation or test results up to one year into the trial.
- You have a significant abnormality found on a heart tracing test (ECG) at the screening visit.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: ABBVIE INC., AbbVie
Phone: 844-663-3742
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of Participants with Adverse Events (AEs); Change from Baseline in B Cells in Blood and Tissue; Maximum Plasma Concentration (Cmax) of ABBV-319; Time to Cmax (Tmax) of ABBV-319; Terminal Phase Elimination Half-Life (t1/2) of ABBV-319; Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319; Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319; Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.