Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06977724

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)

Led by AbbVie · Updated on 2026-05-12

36

Participants Needed

6

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

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) and Sjogren's Disease (SjD)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of systemic lupus erythematosus (SLE) for at least 6 months before screening, meeting 2019 EULAR/ACR SLE classification criteria
  • Positive antinuclear antibody (ANA) titer of 1:80 or higher at screening
  • Presence of anti-dsDNA, anti-Smith, anti-RNP, or anti-SSA antibodies above normal limits for SLE participants
  • Primary diagnosis of Sjogren's disease (SjD) for at least 6 months before screening, meeting 2016 ACR/EULAR criteria
  • EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score of 5 or higher at screening for SjD participants
  • EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score of 5 or higher at screening for SjD participants
Not Eligible

You will not qualify if you...

  • History of infection as defined in the study protocol
  • Presence of certain medical diseases or disorders listed in the protocol
  • Clinically significant drug or alcohol abuse within 6 months before screening
  • Planned elective surgery that would affect study procedures or assessments through day 365
  • Clinically significant ECG abnormalities at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

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

Margate, Florida, United States, 33063

Actively Recruiting

2

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

Tampa, Florida, United States, 33606

Actively Recruiting

3

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

Memphis, Tennessee, United States, 38119

Actively Recruiting

4

Integrative Rheumatology of South Texas - Harlingen /ID# 276458

Harlingen, Texas, United States, 78550

Actively Recruiting

5

Amsterdam UMC, locatie AMC /ID# 274286

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

6

Universitair Medisch Centrum Utrecht /ID# 273398

Utrecht, Netherlands, 3584 CX

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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