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) and Sjogren's Disease (SjD)

Phase 1

Recruiting

• Conditions: Dry Eye Syndrome; Systemic Lupus Erythematosus
• Interventions: Drug: ABBV-319

• Registration Number: NCT06977724
• Lead Sponsor: AbbVie

Brief Summary

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity and 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. ABBV-319 exhibits potential B cell depletion in SLE and SjD 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 or SjD.

ABBV-319 is an investigational drug being developed for the treatment of SLE and SjD. Participants are placed in 1 of 6 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE or SjD. Around 36 adult participants with SLE or SjD will be enrolled at approximately 10 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-18
• Study Start: 2025-08-26
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-27
• Last Update Posted: 2025-10-28
• Primary Completion: 2029-03
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABBV-319 Group 1: SLE Participants	ABBV-319	Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.
ABBV-319 Group 2: SLE Participants	ABBV-319	SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.
ABBV-319 Group 3: SLE Participants	ABBV-319	SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.
ABBV-319 Group 4: SLE Participants	ABBV-319	SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.
ABBV-319 Group 5: SjD Participants	ABBV-319	Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.
ABBV-319 Group 6: SjD Participants	ABBV-319	SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in B Cells in Blood and Tissue	Up to approximately 400 days	Change from baseline in B cells in blood and tissue.
Maximum Plasma Concentration (Cmax) of ABBV-319	Up to approximately 400 days	Cmax of ABBV-319.
Time to Cmax (Tmax) of ABBV-319	Up to approximately 400 days	Tmax of ABBV-319.
Number of Participants with Adverse Events (AEs)	Up to approximately 400 days	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319	Up to approximately 400 days	t1/2 of ABBV-319.
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319	Up to approximately 400 days	AUCt of ABBV-319.
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319	Up to approximately 400 days	Percentage of participants with detection of ADAs for ABBV-319.
Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319	Up to approximately 400 days	Percentage of participants with detection of nAbs for ABBV-319.

Trial Locations

Locations (2)

Private Practice - Dr. Ramesh C. Gupta I /ID# 275826; 🇺🇸 Memphis, Tennessee, United States

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836; 🇺🇸 Tampa, Florida, United States