Clinical trial Recruiting at 22 sites Observational Ages 18 to 110

Registry and biorepository for lupus patients

Official title: Lupus Nexus Landmark Study: A Prospective Registry and Biorepository

Run by Lupus Research Alliance · NCT05934149 · Data updated 2026-11-12

This study is gathering information and samples from over 3,500 people with lupus to help researchers learn more about the condition and improve treatments.

Quick facts

Study typeObservational
Ages18 Years to 110 Years
SexAll
Enrollment3500 (estimated)
SponsorLupus Research Alliance
Academic / other
Locations25 sites (Birmingham, Alabama and 24 other locations)
StatusRecruiting
StartedJune 28, 2023
Main results expectedDecember 2035
Study endsDecember 2035
Registry record updatedApril 15, 2026
Trial IDNCT05934149 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 18 and older with a diagnosis of Systemic Lupus Erythematosus.

Probably not a fit

Patients who are unable to provide consent or are pregnant at the time of enrollment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter registry and biorepository aims to enroll over 3500 individuals with Systemic Lupus Erythematosus (SLE) over five years. Participants will be categorized into four cohorts based on their condition, including new onset SLE and active lupus nephritis. The study will collect extensive clinical data, patient-reported outcomes, and biological samples for future research on SLE. This initiative seeks to enhance understanding of lupus through comprehensive data collection and biospecimen analysis.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with lupus.

How similar studies have gone: Other studies utilizing similar registry and biorepository approaches have shown promise in advancing research and treatment for chronic diseases.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Able to understand and comply with study procedures and voluntarily sign a written informed consent document
* Age 18 years or older at the time of enrollment
* Fulfill criteria for SLE based on one or more of the following classifications systems:

Systemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 criteria; European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 criteria; 1997 revised ACR criteria; or Lupus is present per clinical assessment.

Exclusion Criteria:

* Not able to obtain consent
* Not able to meet protocol visit requirements
* Pregnant at the time of enrollment

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • University of Arizona
    Tucson, Arizona, United States
    Recruiting
  • Wallace Rheumatic Studies Center
    Beverly Hills, California, United States
    Recruiting
  • University of Miami
    Miami, Florida, United States
    Recruiting
  • Emory University
    Atlanta, Georgia, United States
    Recruiting
  • University of Chicago
    Chicago, Illinois, United States
    Recruiting
Show 19 more locations
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • University of Massachusetts Memorial Health
    Worcester, Massachusetts, United States
    Recruiting
  • Washington University
    St Louis, Missouri, United States
    Recruiting
  • The Feinstein Institutes for Medical Research
    Manhasset, New York, United States
    Recruiting
  • Northwell Health
    New York, New York, United States
    Recruiting
  • SUNY Upstate
    Syracuse, New York, United States
    Recruiting
  • UNC Chapel Hill
    Chapel Hill, North Carolina, United States
    Recruiting
  • The MetroHealth System
    Cleveland, Ohio, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting
  • UT Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting
  • University of Calgary
    Calgary, Alberta, Canada
    Recruiting
  • University of Alberta Hospital
    Edmonton, Alberta, Canada
    Recruiting
  • University of Manitoba
    Winnipeg, Manitoba, Canada
    Recruiting
  • University Health Network/Toronto Western Hospital
    Toronto, Ontario, Canada
    Recruiting
  • McGill University Health Centre
    Montreal, Quebec, Canada
    Recruiting
  • CHU de Québec - Université Laval
    Québec, Quebec, Canada
    Recruiting
  • UCLA
    Los Angeles, California, United States
    Not yet recruiting
  • Georgetown University
    Washington D.C., District of Columbia, United States
    Not yet recruiting
  • Columbia University Medical Center
    New York, New York, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis

    This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.

    Recruiting Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07760480

  • Evaluating FT819 for autoimmune diseases

    This study is testing a new treatment called FT819 to see if it can safely help people with moderate to severe autoimmune diseases feel better.

    Recruiting at 21 sites Phase 1 Fate Therapeutics · Beverly Hills, California and 20 other locations · NCT06308978

  • Comparing treatments for lupus nephritis without added oral steroids

    This study is testing whether a treatment for lupus nephritis using obinutuzumab and mycophenolate mofetil without steroids can work just as well as a treatment that includes steroids.

    Recruiting Phase 3 Assistance Publique - Hôpitaux de Paris · Paris · NCT04702256

  • Long-Term Extension of enpatoran for cutaneous lupus symptoms

    This extension study tests whether continuing enpatoran is safe and helpful for people with skin lupus who completed previous trials, for up to about two years.

    Recruiting Phase 3 EMD Serono · Troy, Michigan · NCT07840287

  • Targeting B cells and plasma cells in lupus with a dual-action antibody

    A new injectable therapy (F182112) will be tested in adults with systemic lupus erythematosus to see if it can help by hitting both CD3 on immune cells and BCMA on B cells and plasma cells.

    Recruiting Phase 1 Shandong New Time Pharmaceutical Co., LTD · Shanghai · NCT07829614

  • FT839 therapy for autoimmune diseases

    This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

    Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.