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Taking people in NetherlandsPhase 1

Tests ABBV-319 in adults with lupus, Sjogren's disease or rheumatoid arthritis

Tests the drug ABBV-319 in adults with lupus, Sjogren's or arthritis.

Key facts

Who runs it
AbbVie
Where
Amsterdam and Utrecht, NetherlandsSee the 2 sitesAlso in 2 other countries, 9 sites
Registry 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), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
Status
Recruiting
Phase
Phase 1
People taking part
36 people, planned
Started
26 Aug 2025
Expected to end
Mar 2029
Type of study
Interventional, 8 groups
Treatments tested
  • ABBV-319
Record updated
10 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with lupus (SLE), Sjogren's disease (SjD) or rheumatoid arthritis (RA) to test the drug ABBV-319. It looks at how the drug moves through the body, its safety and how well it works.

Age
18 to 75 years
Sex
Women and men can join.
Disease stage
SLE: diagnosed at least 6 months before screening. SjD: diagnosed at least 6 months before screening, with ESSDAI of 5 or more and ESSPRI of 5 or more. RA: at least 6 swollen and 6 tender joints and hs-CRP of 3 mg/L or more.
Biomarker or test result
SLE: positive antinuclear antibody (ANA) of 1:80 or more, plus anti-dsDNA, anti-Sm, anti-RNP or anti-SSA antibodies above the upper limit of normal. RA: rheumatoid factor (RF) or ACPA above the upper limit of normal.

Main reasons for not taking part

  • History of infection as defined in the protocol
  • Other medical diseases or disorders listed in the protocol
  • Drug or alcohol abuse within the 6 months before screening
  • Planned elective surgery that would affect the study until Day 365
  • RA: history of overlap syndromes such as SLE, SjD, scleroderma, mixed connective tissue disease or polymyositis

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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 - 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
  • Rheumatoid Arthritis (RA) Population - Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA
  • RA Population - Rheumatoid Factor (RF) or ACPA above the ULN at Screening
  • RA Population - Confirmation of at least moderate disease activity at Screening, defined by both of the following disease activity criteria:; Presence of at least 6 swollen and 6 tender joints at Screening using the 68 (tender)/66 (swollen) joint count; hs-CRP ≥3 mg/L

Who cannot take part

  • 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
  • History of infection as defined in the protocol
  • Any of the medical diseases or disorders listed in the protocol
  • RA-Specific Exclusion Criteria - History of RA overlap syndromes, including but not limited to, SLE, SjD, scleroderma, mixed connective tissue disease, or polymyositis
  • Any clinically significant ECG abnormalities at Screening

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Netherlands

Also in 2 other countries, 9 sites

  • Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 8 groups in the trial

  • ABBV-319 Group 1: SLE ParticipantsTreatment being tested

    Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.

    Treatment: ABBV-319

  • ABBV-319 Group 2: SLE ParticipantsTreatment being tested

    SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.

    Treatment: ABBV-319

  • ABBV-319 Group 3: SLE ParticipantsTreatment being tested

    SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.

    Treatment: ABBV-319

  • ABBV-319 Group 4: SLE ParticipantsTreatment being tested

    SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.

    Treatment: ABBV-319

  • ABBV-319 Group 5: SjD ParticipantsTreatment being tested

    Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

    Treatment: ABBV-319

  • ABBV-319 Group 6: SjD ParticipantsTreatment being tested

    SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

    Treatment: ABBV-319

  • ABBV-319 Group 7: RA ParticipantsTreatment being tested

    Rheumatoid Arthritis (RA) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

    Treatment: ABBV-319

  • ABBV-319 Group 8: RA ParticipantsTreatment being tested

    RA participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

    Treatment: ABBV-319

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase1b, Multiple Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Safety, and Efficacy of ABBV-319 in Subjects With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
Plain-language title
Tests ABBV-319 in adults with lupus, Sjogren's disease or rheumatoid arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06977724, who can take part
Record updated
10 August 2026