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)
NCT ID: NCT06977724
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2025-08-26
2029-03-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ABBV-319 Group 1: SLE Participants
Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.
ABBV-319
Intravenous (IV) Infusion
ABBV-319 Group 2: SLE Participants
SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.
ABBV-319
Intravenous (IV) Infusion
ABBV-319 Group 3: SLE Participants
SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.
ABBV-319
Intravenous (IV) Infusion
ABBV-319 Group 4: SLE Participants
SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.
ABBV-319
Intravenous (IV) Infusion
ABBV-319 Group 5: SjD Participants
Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.
ABBV-319
Intravenous (IV) Infusion
ABBV-319 Group 6: SjD Participants
SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.
ABBV-319
Intravenous (IV) Infusion
Interventions
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ABBV-319
Intravenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Life Clinical Trials /ID# 276050
Margate, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, Florida, United States
Private Practice - Dr. Ramesh C. Gupta I /ID# 275826
Memphis, Tennessee, United States
Amsterdam UMC, locatie AMC /ID# 274286
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2024-519157-10
Identifier Type: OTHER
Identifier Source: secondary_id
M25-433
Identifier Type: -
Identifier Source: org_study_id