Trial studying safety and effects for Dry Eye Syndrome
Official title 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)
ClinicalTrials.gov ID: NCT06977724
What this study is testing
What is ABBV-319?
ABBV-319 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dry eye syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6 months prior to Screening as defined by the 2019 European...
- SLE Population - Anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome Ag A (SSA) Abs above the...
- 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.
You likely 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...
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Avon Park, Florida, United States
- Clearwater, Florida, United States
- Margate, Florida, United States
- Tampa, Florida, United States
- Orland Park, Illinois, United States
- Memphis, Tennessee, United States
- Harlingen, Texas, United States
- Strasbourg, Alsace, France
- Montpellier, Herault, France
- Amsterdam, North Holland, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avon Park, Florida, United States; Clearwater, Florida, United States; Margate, Florida, United States; Tampa, Florida, United States; Orland Park, Illinois, United States; Memphis, Tennessee, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.