Recruiting
Phase 1

ABBV-319

Sponsor:

AbbVie

Code:

NCT06977724

Conditions

Dry Eye Syndrome

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ABBV-319

Study Details

Brief summary:

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.

Conditions

Dry Eye Syndrome

Systemic Lupus Erythematosus

Study ID

NCT06977724

Start date

Aug 26, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABBV-319 Group 1: SLE Participants

Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.

experimental: ABBV-319 Group 2: SLE Participants

SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.

experimental: ABBV-319 Group 3: SLE Participants

SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.

experimental: ABBV-319 Group 4: SLE Participants

SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.

experimental: ABBV-319 Group 5: SjD Participants

Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

experimental: ABBV-319 Group 6: SjD Participants

SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

experimental: ABBV-319 Group 7: RA Participants

Rheumatoid Arthritis (RA) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

experimental: ABBV-319 Group 8: RA Participants

RA participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

Interventions

ABBV-319

Intravenous (IV) Infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 400 days ]
  • Change from Baseline in B Cells in Blood and Tissue [ Time Frame: Up to approximately 400 days ]
  • Maximum Plasma Concentration (Cmax) of ABBV-319 [ Time Frame: Up to approximately 400 days ]
  • Time to Cmax (Tmax) of ABBV-319 [ Time Frame: Up to approximately 400 days ]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 [ Time Frame: Up to approximately 400 days ]
  • Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319 [ Time Frame: Up to approximately 400 days ]
  • Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319 [ Time Frame: Up to approximately 400 days ]
  • Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319 [ Time Frame: Up to approximately 400 days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Life Clinical Trials - Colonial Drive - Margate /ID# 276050

Recruiting

Margate, Florida, United States, 33063

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836

Recruiting

Tampa, Florida, United States, 33606

Advanced Quality Medical Research /ID# 278462

Recruiting

Orland Park, Illinois, United States, 60462

Private Practice - Dr. Ramesh C. Gupta /ID# 275826

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Site Coordinator

901-681-9670

Integrative Rheumatology of South Texas - Harlingen /ID# 276458

Recruiting

Harlingen, Texas, United States, 78550

Contacts

Site Coordinator

956-423-1112

More Information

Sponsor

AbbVie

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Dry Eye Syndrome
  • Systemic Lupus Erythematosus
  • ABBV-319

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-10.