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Hope is on the Horizon
Clinical Trial Participation
If you have been diagnosed with Lupus or another medical condition and you are frustrated with the lack of safe and effective treatment choices currently available, then you may want to consider participating in a clinical research trial. Please keep in mind that making the choice to participate in a clinical study is a very personal decision that should be based on discussions between you, your loved ones, and your treating healthcare providers that are the most familiar with your medical history. We cannot emphasize this point strongly enough.
Clinical Study Search Tool
We are very excited to partner with Antidote to launch a clinical research trial search tool. To begin searching for trials for Lupus or another disease, click on the white Start button and respond to the prompts. You will then be asked to answer several questions to help narrow down and identify possible clinical trials for you.
Clinical Research Trial Resources
Clinical Trials - a service of the US NIH
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
The Center for Information & Study on Clinical Research Participation (CISCRP)
CISCRP (Center for Information and Study on Clinical Research Participation) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process.
Learn more at www.ciscrp.org
Coalition for Clinical Trials Awareness (CCTA)
The mission of the Coalition for Clinical Trials Awareness is to advocate for the creation of a federally sponsored public awareness campaign to increase the public’s understanding of the benefits of clinical trials.
Learn more at www.cctawareness.org
United States National Library of Medicine, National Institutes of Health
The National Library of Medicine (NLM), on the campus of the National Institutes of Health in Bethesda, Maryland, has been a center of information innovation since its founding in 1836. The world’s largest biomedical library, NLM maintains and makes available a vast print collection and produces electronic information resources on a wide range of topics that are searched billions of times each year by millions of people around the globe. It also supports and conducts research, development, and training in biomedical informatics and health information technology. In addition, the Library coordinates a 6,500-member Network of the NLM that promotes and provides access to health information in communities across the United States.
Learn more at www.nlm.nih.gov
Office of Research on Women's Health, Office of the NIH Director, National Institutes of Health/DHHS
ORWH is the first Public Health Service office dedicated specifically to promote women's health research within and beyond the NIH scientific community. Women's health research is an essential part of the NIH research agenda. The field includes the study of health throughout the lifespan and across the spectrum of scientific investigations. Learn more at www.orwh.od.nih.gov
Current Lupus Studies
NEX-T Study
BMS is conducting a clinical trial to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of a study drug in adult participants, ages 18-75 years old, with severe refractory Systemic Lupus Erythematosus (SLE). This is a phase 1 study with 11 study sites in the United States. The study treatment period will last about 28 days, with follow up approximately every 28 days for 6 months, then quarterly follow up for about 2 years.
Click here to learn more about the NEXT-T Study
RestoreD Study
Alexion, AstraZeneca Rare Disease is conducting a phase 2 clinical trial called RestoreD, evaluating an oral investigational medication for adults between 18-75 years of age who have been diagnosed with lupus nephritis (LN) or Immunoglobulin A nephropathy (IgAN). To learn more and see if you may qualify to participate, talk to your doctor and visit www.RestoreDStudy.com
Ntrust-1 Study
Nkarta is conducting a Phase 1 clinical trial of an investigational Natural Killer cellular therapy in adults ages 18-65 years old with active Lupus Nephritis (LN). This study evaluates safety, tolerability, and clinical activity, including whether participants can stop other lupus-related medications while improving their LN. The study is currently open for enrollment. To learn more Study Details | NKX019 Clinical Trial
RESET-SLE Study
Cabaletta Bio is conducting a Phase 1/2 clinical trial to evaluate the safety, tolerability and effectiveness of an investigational therapy, including whether this therapy leads to an improvement in lupus symptoms while allowing participants to stop other lupus-related medications. The study is seeking participants aged 18-65 with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), with disease activity despite prior or current treatments, and is currently open for enrollment at centers in the United States.
Click here to learn more about the RESET-SLE study
ELEVATE Study
DxTerity Diagnostics, a Los Angeles based genomics company, is sponsoring an observational research study that uses participant’s health information and a few drops of blood to better understand what it means to live with and manage lupus. They are looking to find a better, easier, and more convenient way for people living with lupus to track and manage their disease from home.
Learn more at www.TheElevateStudy.com
POETYK SLE-1 and SLE-2 Study
BMS is conducting a clinical trial to evaluate the effectiveness, safety and tolerability of a study drug in adult participants, ages 18-75 years old, with active Systemic Lupus Erythematosus (SLE). This is a phase 3 study currently being conducted in 16 countries including the United States. The study will last over 1 year, about 60 weeks. Learn more at Learn More About SLE Studies
RC18G001 Study
RemeGen is conducting a global Phase 3 clinical study to evaluate the safety and efficacy of an investigational medication to treat adults 18-70 years old with systemic lupus erythematosus (SLE) who meet eligibility criteria. To be eligible for the study, patients should have moderate or severe SLE despite receiving standard of care therapies. The study is seeking participants at multiple clinical trial sites in the United States, Europe, Asia, Australia, and South America. This medication is currently approved and available as a prescription to patients in China. Click here to learn more about the RC18G001 Study
IM026-024 SLE Study
BMS is conducting a clinical trial to evaluate the effectiveness, safety and tolerability of a study drug in participants with active Systemic Lupus Erythematosus (SLE). This is a phase 2 study currently being conducted in 17 countries including the United States. The study will last over 1 year, about 57 weeks.
Click here to learn more about the IM026-024 study
JASMINE Study
Janssen is sponsoring a global phase 2 study evaluating the safety and effectiveness of an investigational medication in people with systemic lupus erythematosus (SLE). The study is seeking participants aged 18-65 diagnosed with systemic lupus erythematosus (SLE) 6 months ago or more.
Learn more at https://bit.ly/JasmineSLEStudy
SANCTUARY
Alexion, AstraZeneca Rare Disease is conducting a Phase 2 clinical trial to evaluate the safety and efficacy (effectiveness against disease) of the study medication in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease. To learn more and see if you may qualify to participate, talk to your doctor, and visit www.sanctuarystudy.com
OPUS Study
Idorsia Pharmaceuticals is conducting two global Phase 3 clinical studies to evaluate the safety and efficacy of an investigational medication compared with placebo in adult participants with moderate to severe SLE in 25 countries. Participants who complete 12 months of treatment will be offered the opportunity to enroll in an open-label study, during which they will receive the study drug for approximately 1.5 years.
Learn more at Link
M011-132 DLE/SCLE Study
BMS is conducting a clinical trial to assess the safety, efficacy and tolerability of a study drug compared with
placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE).
This is a phase 2 study currently being conducted in 9 countries including the United States. The study will
last over 1 year, about 60 weeks.
Click here to learn more about IM011-132
TOPAZ Study
Biogen's TOPAZ Study is evaluating the safety and potential efficacy of an investigational medication in people with active systemic lupus erythematosus (SLE) who are still taking their current SLE non-biologic therapy. The TOPAZ Studies will last for a year and a half and include approximately 22 visits to the study site and are being conducted in over 25 countries.
Learn more at www.topazlupusstudy.com
EQUALISE Study
Equillium, Inc. is evaluating the safety and tolerability of an investigational medicine in a phase 1b clinical research study in patients with lupus and lupus nephritis. The study will have two cohorts studied over three defined periods – screening, treatment, and follow-up. The treatment period for patients with systemic lupus erythematosus in Type A Cohort was 4 weeks in duration and is now complete. Treatment for patients with active proliferative lupus nephritis in Type B Cohort is 24 weeks in duration and is also complete with topline data expected early in 2024.
Learn more at https://bit.ly/3qLN7g5
Learn About Clinical Trial Opportunities
To learn about lupus clinical research trial opportunities go to www.clinicaltrials.gov
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Type lupus in the search box and click on the search button.
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Then click on the On Map tab at the top.
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Click on the Geographic Area, Country or State you are interested in and the studies for that area will be listed.
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Click on a specific study for details about the trial's purpose, study eligibility, inclusion and exclusion criteria, locations, and contact information.
The Lupus and Allied Diseases Association, Inc., would like to thank Kathleen Arntsen for her efforts in developing the Hope is on the Horizon program and resource material originally developed in 2004 and copyrighted in 2007.
CAR T CELL THERAPY OVERVIEW
With a great deal of recent news about CAR T cell therapy and with several manufacturers now developing them for lupus and/or lupus nephritis, here is an overview.
Imagine your immune system as an army with the mission to protect your body against disease. When the forces become misguided, the immune system can instead damage the body, causing autoimmune diseases such as lupus.
T cells are a certain type of immune cell that serve as soldiers of the immune system, and they can be trained to recognize and attack specific enemies. In the case of CAR T cell therapy, scientists take some of your T cells and give them special targeting abilities by adding a chimeric antigen receptor (CAR). Once your CAR T cells are returned to your body, this receptor serves as a homing device that guides your CAR T cells to target and destroy specific disease-causing cells. In lupus, these CAR T cells target B cells, another type of immune cell that drives disease in lupus, while potentially allowing healthy B cells to repopulate in your body.
CAR T cell therapies have been approved and made available for individuals with certain types of blood cancers for several years. More recently, evidence has emerged suggesting the potential of a one-time treatment with CAR T cell therapy to provide complete responses to individuals with lupus, allowing them to stop their other lupus-related treatments. This early CAR T cell therapy data also suggests a promising safety profile in people with lupus and other autoimmune diseases. Clinical trials are currently underway to evaluate whether CAR T cell therapies may provide a safe and effective treatment for individuals with lupus.
CAR NK CELL THERAPY OVERVIEW
Cell therapy is one of the newest ways being explored to treat Systemic Lupus Erythematosus (SLE) and/or Lupus Nephritis (LN). SLE is an autoimmune disease that causes the body’s immune system to attack its own tissues. The dysregulated immune system produces antibodies that can affect various organs, including the skin, joints, kidneys, heart, blood vessels and brain.
SLE can range from mild to life-threatening and symptoms can include fatigue, joint pain, sun-sensitivity, musculoskeletal pain, and organ involvement. Individuals with SLE may also develop LN, a severe complication that affects the kidneys. Cell therapy uses healthy living cells (your own or from a donor) to eliminate the cells that are causing the damage.
Natural killer (NK) cells are one type of cells that are being developed for cell therapy. NK cells exist for approximately 2 weeks and are the body’s first line of defense against cancer and bacterial and viral infections by acting quickly to kill dangerous cells before they can multiply. To develop CAR NK cell therapy, scientists take NK cells from people without autoimmune diseases and add a chimeric antigen receptor (CAR), which helps the NK cells find and eliminate specific cells. For lupus treatment, these CAR NK cells are programmed to target B cells, a type of white blood cell that makes proteins called antibodies which cause inflammation in various parts of the body.
CAR NK cell therapies have been used in many people with cancer, and are now being investigated in clinical research studies to evaluate whether CAR NK cells may be a safe and effective treatment for autoimmune diseases such as SLE and LN. Based on early results with other types of cell therapy, this approach may lessen or even stop disease activity and inflammation in SLE or LN, resulting in an individual’s current treatment being modified.
