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Participate in Investigator-Initiated Studies

What are Investigator-Initiated Studies? 

These studies are conducted by individual researchers who have control over the study and its design, as opposed to larger studies conducted by companies or institutions that may have an entire research team. Researchers may or may not be funded to conduct these studies. All studies we share must be certified by an ethics review committee, such as an Institutional Review Board (IRB). We do not share study information without proof of approval.

Research Study Opportunities
TCR Pathfinder: Sequencing a Dynamic Lymphocyte Repertoire in Autoimmunity during Pregnancy (Project CLIO)

Project Clio aims to better understand pregnancy-related immune system changes to help make advancements for disease modifying therapies. Participants of this study will give a blood sample before becoming pregnant. Participants who do become pregnant will give more blood samples during the first, second, and third trimester. A final blood sample will be collected during a postpartum visit. 

Project Clio stands to provide the greatest assistance to those who are planning to become pregnant and for all people with autoimmune disorders. The findings from the research will help to provide more knowledge on the impact of autoimmune diseases in pregnant individuals. 

Participant Eligibility:

  • Age 18 years (or older)
  • Currently pregnant or planning to become pregnant.
  • Diagnosed with non-nephrotic SLE or Multiple Sclerosis
  • Located in: Connecticut, Massachusetts, New Hampshire, Vermont, and Rhode Island.

Participants who complete the study will have sequences of their immune cells (B and T cells) made available to them, potentially allowing for future personalized medical treatments. Processed data will be kept in two separate online data systems; one with unidentifiable data which will be publicly available and another with identifiable data which will only be available by study participants.

Participants will receive monetary compensation for participation.

For more information regarding this study, contact Rakiesha Gay at rakiesha@projectclio.org or visit www.projectclio.org.
 
Study’s end recruitment date is: TBD – Rolling.

Novel Phase 2 double-blind, randomized, controlled clinical trial to evaluate the efficacy of centrally acting, non-toxic ACE inhibition in cognitive impairment associated with SLE

Problems with memory and concentration (cognitive problems) are common in lupus. Cognitive problems can be caused by things like depression, fatigue, medication, and infections. However, previous studies that have been done in animal models of lupus and in lupus patients suggest that inflammation due to lupus can affect the brain directly.
 
The Feinstein Institutes for Medical Research, Division of Autoimmune, Musculoskeletal and Hematopoietic Diseases is conducting a novel phase 2 double-blind, randomized, controlled clinical trial to evaluate the efficacy of centrally acting, non-toxic ACE inhibition in cognitive impairment associated with SLE.
This research study will test the effects of a centrally acting ACE inhibitor, named lisinopril, on resting metabolism in the brain and on cognitive function. Participants will take Lisinopril or Benazepril by oral administration daily, based on titration. The investigators will see if Lisinopril will decrease resting metabolism in the brain and improve cognitive function (memory and concentration) compared to a non-centrally acting ACE inhibitor called benazepril. Imaging (PET Scan) will be conducted at baseline and 12-months.

Eligible Participants:

  • Must be located in New York.
  • Must be able to understand and provide informed consent.
  • Must be between 18 and 65 years of age.
  • Must have stable disease activity and medication doses for 4 weeks prior to screening (stable disease activity is defined as no increase in disease activity requiring an increase or addition of immunosuppressive medications).

Compensation is available for participants.
 
For more information regarding this study, contact Dr. Meggan MacKay at mmackay@northwell.edu.

Study’s end recruitment date: November 1, 2024.

MiSLE: A Phase II Controlled Trial of Human Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Refractory Lupus

The Medical University of South Carolina, in partnership with the National Institutes of Health and the Lupus Foundation of America are enrolling for an FDA approved clinical trial to determine if novel stem cell therapy is effective in treating active lupus. The treatment consists of mesenchymal stem/stromal cells (MSCs) that come from umbilical cords.  The cells are made at the Clean Cell Facility at the Medical University of South Carolina. It is believed these cells can correct some of the immune system problems that cause lupus.

There are two parts to this study: Cohort I and Cohort II. During Cohort I, participants will either receive a dose of 1,000,00 stem cells or placebo (i.e., no cells). For Cohort II, participants will either receive a dose of 5,000,000 stem cells or placebo. The treatment is a one-time infusion that takes approximately half an hour.

Participant Eligibility:

  • Age 18 to 75.
  • Have lupus nephritis and/or lupus without nephritis.
  • Have active lupus despite being on immunosuppressive therapy for 3 months for non-renal disease or 6 months of treatment for lupus nephritis.
  • Can NOT be on Benlysta, Rituxan, or Saphnelo at screening (must be off medications for 3-6 months prior to participation).
  • Located in: California, Georgia, Illinois, New York, North Carolina, Oklahoma, or South Carolina

Participants will receive monetary compensation for participation.

For more information regarding this study, contact Dr. Gary Gilkeson at gilkeson@musc.edu or visit www.medicine.musc.edu.

Study’s end recruitment date is: 07/01/2024.

ALE10: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus (DIVERT)

The Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) is recruiting for an interventional Phase-2 study to evaluate the potential effectiveness and to better understand immunologic changes associated with the loss of clinical response after 24 weeks use of Mycophenolate Mofetil (MMF) in patients with SLE. This study will also explore and compare the effectiveness of voclosporin when added to MMF. Participants will be randomized into 4 groups and receive various dosing of MMF: experimental (MMF), placebo for MMF, MMF and placebo for voclosporin, and MMF and voclosporin.
 
Participant Eligibility:

  • Age 18 to 60.
  • Meet EULAR/ACR criteria for SLE with moderately severe, active, but non-organ threatening disease.
  • Must have completed SARS-CoV-2 primary vaccine series and up to date on booster doses according to CDC guidelines at least 14 days prior to initiation of screening.
  • Women of childbearing potential must have negative serum pregnancy test at screening.
  • Able or willing to use reliable methods of contraception, as outlined in the Mycophenolate REMS brochure for health care providers, from 4 weeks prior to first randomization to 6 weeks after completion of the study. This criterion applies to females of reproductive potential.
  • Located in: California, Connecticut, Georgia, Massachusetts, Minnesota, New York, North Carolina, Oklahoma, and Pennsylvania.

Participants will receive monetary compensation for participation.
 
For more information regarding this study, contact Kaitlin McShea at Kaitlin_McShea@rhoworld.com or visit https://clinicaltrials.gov/ct2/show/NCT05306873?term=ALE10&draw=2&rank=1.
 
Study’s end recruitment date is: 01/01/2025.

Systemic Lupus Self-Management Strategies, Facilitators, and Barriers

Researchers from Indiana University School of Nursing are seeking volunteers to participate in a study researching the self-management experiences of women with Systemic Lupus Erythematosus. Study participants will meet online with research staff to share their experiences in an interview that will last approximately 45 minutes. Participants will be asked questions about managing daily life with Systemic Lupus Erythematosus and barriers that they encounter.

Participant Eligibility:

  • Must be a woman aged 18 or older.
  • Diagnosed with Systemic Lupus Erythematosus (SLE)
  • Have computer access with stable internet/WiFi.
  • Located: 50 contiguous states in United States of America (and US Virgin Islands, Puerto Rico, and Guam).

Compensation is available upon completion of interview.

For more information regarding this study, contact Danielle Short, MSN, MBA, RN at shortdn@IU.edu.

Study’s end recruitment date: December 2024.

Sexual and Reproductive Health in Lupus

Researchers at The Stanford University Departments Medicine and, Epidemiology and Population Health, and Division of Immunology and Rheumatology, are investigating the conversations that people living with lupus have with their rheumatologists around pregnancy and family planning. Researchers are also interested in understanding sexual health and intimacy concerns in relation to lupus to improve care related to reproductive and sexual health. Eligible participants will complete an online questionnaire that will take approximately 10-12 minutes.

Participant Eligibility:

  • Read and understand English.
  • Females ages 18-50 years old.
  • Males ages 18 years or older.
  • Diagnosed with SLE.
  • Located: United States of America (including Puerto Rico and Guam)

There is no compensation for completing the survey, however, upon completion of the survey, participants will have the opportunity to be entered into a drawing for a $25 gift certificate for a retailer of your choice or the opportunity to donate the funds to a charity of your choice. Winners will be randomly selected and notified by September 15, 2024.

For more information regarding this study, visit: https://stanfordmedicine.qualtrics.com/jfe/form/SV_ebpX623HxFZYqCG or contact Dr. Julia Simard, ScD, at SimardLab@stanford.edu.

Study’s end recruitment date is: September 17, 2024.

For Researchers

If you are a researcher interested in sharing your study information, please submit inquires with study details, a signed copy of IRB approval on institutional letterhead, and the subject line "Investigator Initiated Studies Posting Request" via e-mail to registrycoordinator@lupus.org. The Lupus Foundation of America reviews and approves all investigator-initiated studies prior to posting on our website.