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)

Part of paid clinical trials in Avon Park, Florida.

Sponsor
AbbVie
Study ID
NCT06977724
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ABBV-319 — DRUG
    Intravenous (IV) Infusion

Study Details

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.

Key Dates

First listed
May 18, 2025
Start date
Aug 26, 2025
Status verified
Aug 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 400 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239Avon ParkFlorida33825-
Clinical Research Of West Florida - Phase I Unit /ID# 275834ClearwaterFlorida33765-
Life Clinical Trials - Colonial Drive - Margate /ID# 276050MargateFlorida33063-
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836TampaFlorida33606-
Advanced Quality Medical Research /ID# 278462Orland ParkIllinois60462-
Private Practice - Dr. Ramesh C. Gupta /ID# 275826MemphisTennessee38119
Site Coordinator
901-681-9670
Integrative Rheumatology of South Texas - Harlingen /ID# 276458HarlingenTexas78550
Site Coordinator
956-423-1112

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