Phase 1 Lupus Trial, Recruiting NCT07607964 Sponsor: AbbVie Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT07607964
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 75 years old at the time of screening
  • You have a minimum level of certain immune cells (B-cells) in your blood at the start of the trial (confirm with trial site)

If you have Lupus (SLE), you may also need to meet these requirements:

  • You have been formally diagnosed with SLE and meet recognised international classification standards for the condition
  • Specific blood tests show a positive result for certain immune markers linked to lupus (confirm with trial site)
  • Your lupus disease activity score meets a minimum threshold based on a standard medical assessment tool (confirm with trial site)
  • At least one medication used to suppress the immune system has not worked well enough for you, and you took it for at least 3 months

If you have Rheumatoid Arthritis (RA), you may also need to meet these requirements:

  • You have been formally diagnosed with RA and meet recognised international classification standards for the condition
  • Specific blood tests show certain markers associated with RA are above normal levels (confirm with trial site)
  • You currently have at least 6 swollen joints and 6 tender joints
  • A blood inflammation marker called CRP is at or above a certain level (confirm with trial site)
  • At least one standard RA medication and at least one biological or targeted RA medication have not worked well enough for you

Who may not be able to join:

  • You have a history of infection (confirm with trial site for details on type or severity)
  • You have high blood pressure that is not well controlled

If you have Lupus (SLE):

  • You currently have, or have had in the last 6 months, lupus affecting your brain or nervous system (though lupus headaches may be allowed — confirm with trial site)
  • You have active or worsening lupus affecting your kidneys in a serious way (confirm with trial site)
  • You have been diagnosed with lupus alongside another related autoimmune condition, such as RA, Sjogren's disease, or others in this group

If you have Rheumatoid Arthritis (RA):

  • You have been diagnosed with RA alongside another related autoimmune condition, such as lupus, Sjogren's disease, scleroderma, or others in this group

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: ABBVIE INC., AbbVie

Phone: 844-663-3742

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
28 May 2026
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline in B Cells in Blood; Maximum Plasma Concentration (Cmax) of ABBV-519.; Time to Cmax (Tmax) of ABBV-519; Terminal Phase Elimination Half-Life (t1/2) of ABBV-519; Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519; Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519; Number of Participants with Adverse Events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov