SYSTEMIC LUPUS ERYTHEMATOSUS

This study tests an experimental oral drug called BI 3000202 in 405 adults with moderate to severe systemic lupus erythematosus (SLE). Participants are randomly assigned to one of four doses of BI 3000202 or a placebo, taken daily for a year alongside their usual lupus treatments…

This early-phase trial is testing a one-time treatment called obecabtagene autoleucel (obe-cel) for people with severe lupus that hasn't improved with standard treatments. Obe-cel is made by taking a patient's own immune cells, engineering them to target and attack faulty B cells…

This early-stage trial tests a treatment called CAR-T cell therapy for people with severe autoimmune diseases that haven't responded to other treatments. The therapy uses a patient's own immune cells, modified to target and reset the immune system. Only 3 participants will be enr…

This early-stage study tests an experimental drug called LY4298445 in healthy volunteers and people with lupus or rheumatoid arthritis. The main goal is to check safety and how the body handles the drug. Participants will receive either the drug or a placebo, and the study lasts …

This early-phase trial is testing a new type of CAR-T cell therapy for people with severe lupus that hasn't improved with standard treatments. The therapy uses a patient's own immune cells, modified to target two proteins (BCMA and CD70) on harmful cells. The study will enroll 18…

This early study tests whether a single injection of stem cells from donated umbilical cords is safe for people with active lupus. Ten adults will receive the cells plus their usual care. Researchers will monitor side effects and check if the treatment improves kidney function an…

This early-stage trial tests an investigational drug called ABBV-319 in 36 adults with lupus or Sjogren's disease. The drug is designed to deplete overactive B cells, which are part of the immune system that cause inflammation and symptoms. Participants receive two doses by IV, 2…

This early-stage trial is testing a new drug called budoprutug (TNT119) in 30 adults with systemic lupus erythematosus (SLE) who have active disease and haven't responded well to at least two other treatments. The main goal is to check the drug's safety and how the body handles i…

This study tests whether a 'treat-to-target' approach—where doctors adjust treatment every 6 weeks to aim for remission—works better than usual care for people with lupus. About 606 participants who are not in remission will be followed for 120 weeks. The goal is to see if this s…

This early-phase trial is testing a new drug called MTS109, made with mRNA technology, for people with moderate to severe autoimmune diseases like lupus and scleroderma. Fifteen participants will receive several injections over a month to see if it is safe and tolerable. The goal…

This study tests whether belimumab (Benlysta) can help people with early systemic lupus erythematosus (SLE) achieve low disease activity and reduce steroid use. About 350 adults diagnosed with SLE within the past 2 years will receive belimumab injections for up to 3 years. The go…

This Phase 2 trial tests an experimental drug called SHR-2173 in about 248 adults with active systemic lupus erythematosus (SLE). Participants are randomly assigned to receive either the drug or a placebo, and neither they nor their doctors know which they get. The main goal is t…

This early-stage trial tests a new type of CAR-T cell therapy, made quickly from a patient's own immune cells, for people with severe lupus that hasn't improved with standard treatments. The study will enroll 18 adults to check if the therapy is safe and can reduce disease activi…

This early-stage trial is testing a new treatment called CC-97540, which uses a patient's own immune cells modified to target and destroy faulty immune cells. It is for people with severe forms of lupus, myositis, scleroderma, or rheumatoid arthritis that have not improved with s…

This early-stage study is testing a new treatment called PTOC1 cells, which are a type of CAR-T cell therapy, for people with severe systemic lupus erythematosus (SLE) that hasn't improved with standard treatments. The therapy uses a patient's own immune cells, modified in a lab …

This study tests if the drug sirolimus can help adults with lupus who also have very low platelet counts (a condition called immune thrombocytopenia). Participants will receive either sirolimus or a placebo for 24 weeks, then all will receive sirolimus for another 24 weeks. The g…

This early-stage study tests a new injection called AFN50 in 18 adults with autoimmune diseases like lupus. The main goal is to check safety and see how the body reacts, including changes in immune cells. Participants must have active disease despite standard treatments.

This early-phase study tests a new treatment called Meta10-19 for people with moderate to severe systemic lupus erythematosus (SLE). The therapy uses a patient's own immune cells, modified to better target and destroy faulty B cells that drive the disease. The main goals are to f…

This study tests a new treatment using a patient's own immune cells, modified to target and attack faulty immune cells that cause autoimmune diseases. It is for people with severe, hard-to-treat conditions like lupus. The goal is to see if this therapy is safe and can control the…

This study is testing whether the Shingrix vaccine, which protects against shingles, is safe for people with systemic lupus erythematosus (SLE). Researchers want to see if the vaccine causes lupus flare-ups. The trial will involve 224 adults with lupus, who will receive either th…

This study tests a program called CO-LEAD that trains doctors to use effective communication strategies and a patient survey to identify barriers to taking lupus medications. Researchers will enroll 480 patients and their clinicians at two academic centers. The goal is to see if …

This early-stage trial is testing a new drug called GSK4527363 in healthy volunteers and people with active lupus or lupus-related lung disease. The main goal is to check safety and how the body handles the drug. Around 142 participants will take part across four groups, includin…

This study follows 300 lupus patients taking anifrolumab to see how well it works in real life. Researchers will track remission rates, flare-ups, quality of life, and side effects over 5 years. The goal is to confirm whether the drug helps patients achieve lasting disease contro…

This phase 3 study tests anifrolumab, a biologic drug given by IV, in 100 children aged 5 to 18 with moderate to severe systemic lupus erythematosus (SLE). Participants continue their standard care and are randomly assigned to receive anifrolumab or a placebo. The goal is to see …

This early-phase study tests a new drug called AZD5492 in 72 adults with lupus, myositis, or rheumatoid arthritis. The main goal is to check safety and how the body handles the drug. Participants receive one or two injections and are monitored for up to a year.

This early-stage trial is testing a treatment called CABA-201 for people with active systemic lupus erythematosus (SLE), including those with lupus nephritis. CABA-201 is made from a patient's own immune cells, which are modified to target and temporarily remove B cells—a key dri…

This early-stage trial is testing a new drug, alnuctamab, in 21 people with moderate to severe lupus that hasn't improved with standard treatments. The drug is given as an injection under the skin, and participants will stay in the hospital for 9 days after the first dose. The ma…

This study tests whether VENT-03, a tablet, can reduce skin inflammation in people with active cutaneous lupus (with or without systemic lupus). 24 adults will take VENT-03 or a placebo for 4 weeks, then everyone gets VENT-03 for 8 more weeks. Researchers will check skin severity…

This Phase 3 trial is testing whether dapirolizumab pegol, when added to standard lupus treatments, can better control moderate to severe lupus symptoms. About 450 participants will receive either the drug or a placebo. The study aims to see if the drug reduces disease activity o…

This early-phase trial is testing a personalized immune cell therapy called CD19 CAR-T in 15 people with severe autoimmune diseases like lupus and scleroderma that haven't responded to standard treatments. The therapy aims to temporarily deplete certain immune cells to calm the o…

This study compares telitacicept, a newer biologic drug, against the standard treatment cyclophosphamide for lupus patients who also have interstitial lung disease (ILD). About 100 adults with early lupus and ILD will receive either telitacicept or cyclophosphamide, plus usual ca…

This early-stage study tests a new cell therapy called YTS109 in 18 adults aged 18-65 with autoimmune diseases like lupus and Sjogren's syndrome that have not responded to standard treatments. Participants receive a single infusion of the cells, and researchers monitor safety and…

This study looks at whether people aged 60 and older with stable lupus can safely stop taking hydroxychloroquine, a common medication that can cause eye damage over time. About 330 participants will either continue the drug or switch to a placebo and be monitored for one year. Th…

This study tests a new treatment that uses specially designed immune cells (AD-PluReceptor-NK cells) combined with a drug called tafasitamab and chemotherapy to control autoimmune diseases like systemic sclerosis, lupus, and lupus nephritis. The study has three parts: first check…

This early-stage study tests a single dose of ABBV-519 in 30 adults with moderate lupus or rheumatoid arthritis. Researchers will check how the drug moves through the body, how it affects immune cells, and whether it is safe. Participants will be followed for about a year to moni…

This early-phase study tests an experimental cell therapy called LUCAR-DKS1 in 36 adults whose autoimmune diseases (like lupus) have not responded to standard treatments. The main goals are to check safety and find the right dose. This is not a cure—patients may still need long-t…

This early-stage study tests a new drug, GT801, in 22 adults with moderate to severe autoimmune diseases that haven't responded to standard treatments. The main goals are to check safety and find the right dose. Researchers will also look for signs that the drug helps control the…

This early-stage study tests an experimental drug called UB-VV410 in 21 adults with active lupus (including lupus nephritis) that hasn't improved with standard treatments. The main goals are to check safety, find the best dose, and see early signs of effectiveness. Participants w…

This study is testing a new treatment called STR-P004 for people with autoimmune diseases that have come back or not responded to other treatments. The main goal is to see if it is safe and what side effects it may cause. About 39 adults will take part in this early-stage trial.

This study tests a new medicine called E6742 for people with systemic lupus erythematosus (SLE), a chronic autoimmune disease. The goal is to see if E6742 can reduce lupus disease activity better than a placebo, while allowing lower doses of steroids. About 256 adults with active…

This study tests whether a stem cell transplant using the patient's own cells can help young people (ages 8 to 25) with life-threatening lupus or scleroderma. The goal is to wipe out the faulty immune system and allow a new, healthy one to grow. The trial will track how long pati…

This early-stage study tests a new drug called A-319 in 25 adults with active or hard-to-treat lupus. The goal is to see if the drug is safe and how it affects the body. A-319 is a special antibody that targets immune cells to help control the disease.

This early-stage study tests a new drug called surovatamig in 48 adults with rheumatoid arthritis or lupus. The main goal is to check safety and how the body handles the drug. Participants receive increasing doses to find the best and safest level.

This early-stage trial tests a new treatment for children and young adults (ages 2-30) with severe lupus that hasn't responded to standard therapies. The treatment involves collecting a patient's own immune cells, engineering them to target and destroy faulty B cells (which drive…

This study tests two medications, inebilizumab and blinatumomab, in adults with active lupus (with kidney inflammation) or hard-to-treat rheumatoid arthritis. The goal is to see if these drugs are safe and can help control the diseases. About 220 people will take part. This is no…

This early-phase trial tests a new treatment called zamto-cel for people with severe lupus or scleroderma that hasn't improved with standard therapies. Zamto-cel uses a patient's own immune cells, modified to target and calm the overactive immune system. The main goal is to check…

This early-stage study tests a single injection of a new drug, LBL-047, in healthy adults and people with mild-to-moderate systemic lupus erythematosus (SLE). The main goal is to check safety and side effects. About 112 participants will receive either the drug or a placebo. This…

This early-phase study tests a new treatment called Arnovie101 for people with lupus or autoimmune hemolytic anemia. The therapy uses mRNA to create CAR-T cells inside the body, aiming to target and control overactive immune cells. Only 5 participants will be enrolled to check sa…

This study tests a new treatment using specially engineered immune cells (CAR-NK) from cord blood for people with severe autoimmune diseases like lupus, scleroderma, and vasculitis that haven't responded to standard therapies. The goal is to see if it's safe and can control the d…

This study is for people who have both an autoimmune disease (like rheumatoid arthritis, lupus, or multiple sclerosis) and an advanced cancer that has spread or cannot be removed by surgery. It tests the safety and effectiveness of the immunotherapy drug nivolumab, given alone or…

This early-phase study tests a new type of CAR-T cell therapy (called KN3601) for people with severe autoimmune diseases like lupus, scleroderma, Sjögren's syndrome, rheumatoid arthritis, and vasculitis that haven't responded to standard treatments. The therapy uses specially eng…

This study tests a new medicine called MIL62 for people with systemic lupus erythematosus (SLE), a chronic autoimmune disease. About 316 adults with active lupus will receive either MIL62 or a placebo to see if it safely reduces disease activity and allows lower steroid use. The …

This early-stage study tests a new therapy, HN2301, in 30 adults with lupus, scleroderma, or rheumatoid arthritis. The main goal is to check safety and find the right dose. Researchers will also look for early signs that the treatment helps control the disease by measuring immune…

This study looks at the long-term safety of a drug called ianalumab for people with systemic lupus erythematosus (SLE). It is for those who already completed a previous ianalumab study. About 550 participants will receive either ianalumab or a placebo to track side effects and se…

This early-stage study tests a new drug, CPTX2309, to see if it is safe and tolerable. It involves 64 healthy adults and people with moderate to severe rheumatoid arthritis or lupus. Researchers will monitor side effects, lab results, and immune responses to determine the drug's …

This early-stage study tests a new drug (GSK5926371) in people with lupus and similar autoimmune diseases. The drug is designed to target and calm specific immune cells that attack the body. The main goal is to check if the drug is safe and how the body handles it, with 54 adults…

This early-stage trial tests a new, quickly-made CAR-T cell therapy for people with severe lupus that hasn't responded to standard treatments. The therapy uses a patient's own immune cells, modified to target and destroy faulty B cells driving the disease. The study aims to see i…

This study tests a new treatment called anti-CD19/BCMA universal CAR-T cells for people with severe autoimmune diseases like rheumatoid arthritis, lupus, and scleroderma. The therapy aims to reset the immune system by targeting and removing faulty B cells. About 72 adults will re…

This study tests a new treatment called QT-219CX, which uses specially engineered immune cells (CAR-T cells) to target and calm the overactive immune system in people with autoimmune diseases like lupus, kidney disease, and scleroderma. The treatment is given as a one-time infusi…

This study tests whether the drug anifrolumab can improve blood vessel health and reduce inflammation in people with lupus, who face higher risks of heart attacks and strokes. About 45 adults with lupus will receive either anifrolumab or a placebo through IV infusions over 8 mont…

This study tests a new treatment for people with lupus, scleroderma, dermatomyositis, or polymyositis. The treatment uses a patient's own immune cells, which are modified in a lab to find and attack faulty B cells that drive the disease. The goal is to control the autoimmune atta…

This study tests a drug called mosunetuzumab in 30 people with lupus, a disease where the immune system attacks the body. The goal is to see if the drug can put lupus into remission so that participants can stop most lupus medications for at least 6 months. However, some people m…

This early-stage study tests a new treatment for people with severe autoimmune diseases like lupus and scleroderma that haven't improved with standard therapies. The treatment uses specially engineered immune cells (CAR T-cells) from a healthy donor to target and potentially rese…

This early-phase study tests whether a new drug called ONT01 is safe for people with lupus nephritis or systemic lupus erythematosus (SLE). About 61 participants will receive ONT01 alongside their usual lupus medications. The goal is to find the highest safe dose and see if it im…

This study tests a medicine called anifrolumab for people with lupus who have not taken strong immune-suppressing drugs before. The goal is to see if the drug can help patients reach remission and reduce or stop their steroid use. About 245 adults will receive weekly injections f…

This study is testing a new blood test (the HMEC test) to see if it can better identify which patients with thrombotic microangiopathy (TMA) have a specific immune system problem driving their disease. TMA is a severe condition that damages kidneys and the brain. The researchers …

This study looks at whether tiny particles in urine can help detect and monitor lupus-related kidney damage without needing an invasive biopsy. Researchers will compare urine test results with standard kidney biopsy findings in 40 adults with lupus. If successful, this could lead…

This study tests whether using a carotid ultrasound (a neck scan) to detect hidden plaque in arteries can better prevent heart attacks and strokes in people with inflammatory rheumatic diseases like rheumatoid arthritis and lupus. About 1,944 participants aged 50 and older will b…

This study tests whether online group programs to manage fatigue can help people with lupus. Participants will either receive a fatigue booklet alone or also attend online group sessions (4 or 7 weeks long). The goal is to see if the programs reduce fatigue impact and improve qua…

This study tests an online program that teaches diet and self-care habits to adults with rheumatoid arthritis, lupus, Sjogren's syndrome, mixed connective tissue disease, or psoriatic arthritis. Researchers want to see if the program reduces fatigue and improves quality of life. …

This early-stage study tests a new medicine called MK-1045 in 21 people with lupus or rheumatoid arthritis. The main goal is to check if the drug is safe and tolerable at different dose levels. Researchers will monitor side effects and how the body processes the drug. This is a f…

This observational study follows up to 20,000 children and young adults with pediatric-onset rheumatic diseases, such as juvenile idiopathic arthritis. Researchers collect data on treatments, safety, and long-term outcomes to better understand these conditions. The registry does …

This study looks at specific immune cells (iNKT cells and monocytes) in people with lupus to see how certain receptors on these cells change when the disease is active versus stable. Researchers will collect extra blood samples from 50 lupus patients during routine visits. The go…

This study is testing an educational tool designed for people with melanoma who also have an autoimmune disease and are considering treatment with immune checkpoint inhibitors. Researchers want to see if the tool is easy to use and helpful for both patients and healthcare provide…

This study aims to collect blood samples and medical data from 3000 people with autoimmune diseases like lupus, scleroderma, and myositis. Researchers will use these samples to identify new biomarkers and better understand the diseases. The goal is to support future research into…

This study is trying to understand why some people who take Plaquenil (a drug for lupus and rheumatoid arthritis) develop damage to their retina, while others don't. Researchers will compare the genes of people who have had this eye damage with those who haven't, using blood samp…

This study looks at how a type of cell death called ferroptosis, which is linked to iron, plays a role in lupus. Researchers will measure certain markers in immune cells from 120 people with lupus, as well as from people with other inflammatory diseases. The goal is to better und…

This study looks at how changes in the TREX1 gene are linked to lupus, especially skin problems. Researchers will check disease activity in 90 adults with lupus using a standard scoring tool. No new treatment is given; the goal is to better understand the disease.

This registry enrolls pregnant women or those planning pregnancy who have autoimmune diseases like lupus or rheumatoid arthritis. Researchers at Duke University will track health data to find ways to improve outcomes for mothers and babies. The goal is to better understand risk f…

This study looks at how well the shingles vaccine (Shingrix) works in people with lupus compared to healthy people of the same age and sex. Researchers will measure immune cell responses after two doses and follow participants for up to 5 years. The goal is to understand if the v…

This study is building a large registry and biorepository of 5,000 adults with various rheumatic diseases like rheumatoid arthritis, lupus, and scleroderma. Researchers at Yale University will collect medical data and biological samples over time to better understand these condit…

This study is a registry that will follow 1,000 adults with systemic lupus erythematosus (SLE) over time. Researchers will collect information during routine doctor visits to learn more about how lupus presents, is managed, and what outcomes patients experience. No new drugs or t…

This observational study is following 700 pregnant women with lupus or antiphospholipid syndrome across nine medical centers. Researchers are looking at specific proteins in the blood to see if they can predict serious pregnancy complications like fetal death, preterm delivery, o…

This study is collecting blood, urine, and stool samples from 500 children with autoimmune or inflammatory diseases, as well as healthy controls. Researchers will analyze these samples to find molecular patterns that could lead to a tool for better diagnosis and treatment decisio…

This study looks at how immune cells and inflammatory molecules differ in people with migraine, especially those who also have autoimmune diseases like multiple sclerosis, rheumatoid arthritis, or endometriosis. Researchers will compare blood samples from 396 women to measure reg…

This study looks at why some lupus patients get false positive results on tests for HLA antibodies, which can make it harder to get an organ transplant. Researchers will study 30 adults with lupus who have no known risk factors for these antibodies. The goal is to find better way…

This study aims to learn more about how lupus (SLE) develops and changes over time by observing patients and their relatives. Up to 2000 people aged 3 and older with known or suspected lupus, along with their family members, will provide medical history, blood and urine samples, …

This study is creating a registry of 1,000 people with lupus (systemic lupus erythematosus or cutaneous lupus) to collect health information and blood samples over time. The goal is to learn how lupus changes and find better ways to treat it. Participants must be patients at Duke…

This study tracks 240 pregnant women with lupus who have taken the drug anifrolumab. Researchers will monitor for birth defects and other pregnancy complications. The goal is to better understand the drug's safety during pregnancy.

This study follows about 442 pregnant women with lupus to see if taking the drug anifrolumab during pregnancy is linked to birth defects or other problems in the baby. Researchers will compare women who took the drug with those who did not. No new treatments are given—this is an …

This study looks at how the immune system ages faster in people with lupus. Researchers will measure specific immune cells and telomeres in 75 adults with lupus. The goal is to understand the aging process better, not to test a new treatment.

This study aims to learn how well heart scans (MRI, ultrasound, PET) can detect and predict outcomes in people with suspected or known inflammatory heart diseases. Researchers will follow 5,000 adults for one year to see how often heart involvement is confirmed and how it affects…

This study looks at how much of the lupus drug anifrolumab passes into breast milk and into the baby's blood. It involves 16 breastfeeding women with lupus who are already taking the drug. The goal is to gather safety information, not to test a new treatment.

This study is working to create a new, objective way to measure pain and treatment effects in children with juvenile arthritis, lupus, or fibromyalgia. Researchers will follow 90 children for one year, taking pain measurements during regular clinic visits. The goal is to replace …

This study watches over 3,000 adults with moderate-to-severe lupus to see if the drug anifrolumab increases the risk of serious infections or cancer compared to standard treatments. No new medicine is given—researchers simply analyze health records from people already prescribed …