A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Part of paid clinical trials in Anniston, Alabama.

Sponsor
AbbVie
Study ID
NCT07607964
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • ABBV-519 — DRUG
    Intravenous (IV) Infusion
  • ABBV-519 — DRUG
    Subcutaneous (SC) Injection

Study Details

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA. This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally. 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 27, 2026
Start date
May 28, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: Dose A
    Participants will receive a single intravenous (IV) dose of ABBV-519
  • Experimental: Group 2: Dose B
    Participants will receive a single intravenous (IV) dose of ABBV-519
  • Experimental: Group 3: Dose C
    Participants will receive a single intravenous (IV) dose of ABBV-519
  • Experimental: Group 4: Dose D
    Participants will receive a single subcutaneous (SC) dose of ABBV-519
  • Experimental: Group 5: Dose E
    Participants will receive a single subcutaneous (SC) dose of ABBV-519

Primary Outcome Measure

Change from Baseline in B Cells in Blood [ Time Frame: Up to 365 Days ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group /ID# 278677AnnistonAlabama36207-
UCLA Health West Medical Campus /ID# 282811Los AngelesCalifornia90095-
Solace Research /ID# 279155TustinCalifornia92780-
Clinical Research Of West Florida - Phase I Unit /ID# 279292ClearwaterFlorida33765-
Finlay Medical Research - Greenacres /ID# 278380Greenacres CityFlorida33467-
Clinical Research of Osceola /ID# 278374KissimmeeFlorida34741-
Discovery Health Research Center /ID# 279691PlantationFlorida33317-
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130TampaFlorida33606-
Advanced Quality Medical Research /ID# 279147Orland ParkIllinois60462-
Epic Medical Research /ID# 279180Red OakTexas75154-

Find similar trials in Anniston, AL

By condition
Rheumatoid arthritisLupus (SLE)
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Pinnacle Research Group· Anniston, ALUCLA Health West Medical Campus· Los Angeles, CASolace Research· Tustin, CAClinical Research Of West Florida - Phase I Unit· Clearwater, FLFinlay Medical Research - Greenacres· Greenacres City, FLClinical Research of Osceola· Kissimmee, FL

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