SYSTEMIC LUPUS ERYTHEMATOSUS

This study tests whether the shingles vaccine is safe and works well for people with lupus, a condition that can weaken the immune system. About 224 adults with lupus will receive either the vaccine or a placebo, and researchers will monitor for lupus flares and immune response o…

This study tests an experimental drug called VENT-03 in 24 adults with active cutaneous lupus (lupus that affects the skin), with or without systemic lupus. For the first 4 weeks, some participants get VENT-03 and some get a placebo; then everyone gets VENT-03 for 8 more weeks. T…

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 early-stage trial tests a new, quick-to-make CAR-T cell therapy for people with severe lupus that hasn't improved with standard treatments. The goal is to see if it's safe and can reduce disease activity, aiming for low disease activity or remission. About 18 adults with mod…

This study tests whether adding dapirolizumab pegol to standard lupus treatments can better control moderate-to-severe lupus symptoms over 48 weeks. About 450 adults with active lupus will receive either the drug or a placebo. The goal is to see if the drug improves disease activ…

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 trial is testing a new treatment called PTOC1 cells, a type of CAR-T cell therapy, for people with severe systemic lupus erythematosus (SLE) that hasn't responded to standard medications. The study will enroll 18 participants aged 5 and older to see if the therap…

This study tests a new treatment called CABA-201 for people with active systemic lupus erythematosus (SLE), including those with lupus-related kidney disease. The therapy uses a patient's own immune cells that are modified in a lab to find and destroy faulty B cells, which drive …

This early-stage study tests a new medicine called GSK4527363 in healthy volunteers and people with active lupus or lung disease linked to connective tissue disorders. The main goal is to check safety and how the body processes the drug. About 142 participants will take part acro…

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 study tests a new medicine called LY4298445 to see if it is safe and tolerable. It involves healthy volunteers and people with lupus or rheumatoid arthritis. Participants receive either the drug or a placebo and are followed for up to a year. The goal is to under…

This study tests a new medicine called SHR-2173 for people with active systemic lupus erythematosus (SLE), a chronic autoimmune disease. About 248 adults will receive either the drug or a placebo to see if it reduces disease activity over 24 weeks. The goal is to manage symptoms …

This study tests a new treatment for people with autoimmune disorders like systemic sclerosis, lupus, and lupus nephritis. It combines a special immune cell therapy (AD-PluReceptor-NK cells) with a drug called tafasitamab and chemotherapy to try to control the disease. The study …

This study tests a drug called belimumab in 350 adults recently diagnosed with lupus (within 2 years). The goal is to see if it can reduce disease activity and prevent flares over 3 years. Participants receive belimumab as a weekly shot, and researchers will monitor safety and ef…

This study compares two treatments for lung scarring (interstitial lung disease) caused by lupus. One group gets telitacicept, a newer drug, and the other gets cyclophosphamide, the current standard. The goal is to see which better improves lung function and is safer. About 100 a…

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 an investigational drug called ABBV-319 in about 36 adults with lupus or Sjogren's disease. The drug is designed to lower the number of overactive B cells, which are immune cells that cause inflammation in these conditions. The main goals are 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 early-phase study tests a new type of CAR-T cell therapy (Meta10-19) for people with moderate to severe systemic lupus erythematosus (SLE) that remains active despite standard treatment. The therapy aims to control the disease by targeting and eliminating faulty immune cells…

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-stage study tests a single dose of ABBV-519 in about 30 adults with moderate lupus or rheumatoid arthritis. The goal is to 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 …

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 early-phase trial tests a new treatment called obecabtagene autoleucel (obe-cel) for people with severe lupus that hasn't responded to other therapies. Obe-cel uses a patient's own immune cells, modified to target and attack faulty B cells driving the disease. The study aims…

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 trial tests a new mRNA drug called MTS109 in 15 people with moderate to severe autoimmune diseases like lupus and scleroderma. The main goal is to check safety and side effects, not yet to prove it works. Participants receive the drug by IV and are monitored clos…

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, fast-made 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 and calm the overactive immune system. The goal is to reduce disease acti…

This study tests whether people aged 60 and older with stable lupus can safely stop taking hydroxychloroquine, a drug that can damage the eyes over time. Half of the 330 participants will switch to a placebo, while the other half stays on the drug. Researchers will monitor for lu…

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 study tests an experimental pill, BI 3000202, in 405 adults with moderate to severe lupus. Participants take the medicine or a placebo for one year while continuing their usual lupus treatments. The goal is to see if the drug reduces disease activity and allows lower steroid…

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 early-phase study tests a new treatment called CC-97540, which uses a person's own immune cells (CAR T cells) to target and calm overactive immune responses in severe autoimmune diseases like lupus, myositis, scleroderma, and rheumatoid arthritis. The goal is to see if it is…

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 early-stage study tests a new drug called AZD5492 in 72 adults with lupus, myositis, or rheumatoid arthritis. The main goal is to check if the drug is safe and how the body processes it. Participants receive either one or two doses under the skin and are monitored for 6 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 drug called alnuctamab in 21 people with moderate to severe lupus that hasn't improved with usual therapies. The drug aims to control the disease by targeting and reducing certain immune cells. The main goals are to check safety and see if it he…

This early-stage study tests a new drug called UB-VV410 in 21 adults with active lupus that hasn't responded to standard treatments. The goal is to find a safe dose and see if it can control the disease, including lupus-related kidney inflammation. Participants will be closely mo…

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-stage study tests a new cell treatment called YTS109 in 18 adults with autoimmune diseases like lupus and Sjogren's syndrome that have not responded to standard therapies. Participants receive a single infusion of these specially designed cells. The main goal is to che…

This study tests an investigational drug called anifrolumab in children aged 5 to 17 with moderate to severe systemic lupus erythematosus (lupus). The goal is to see if adding anifrolumab to standard treatments can better control disease activity. About 100 children will particip…

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 early-stage study tests a single injection of stem cells from donated umbilical cords in 10 adults with active lupus. The goal is to see if the treatment is safe and can improve kidney function and reduce disease activity. Participants continue their usual medications and ar…

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 observing 300 people with active lupus who are taking anifrolumab to see how well it controls the disease and what side effects occur. Researchers will track remission rates, flare-ups, quality of life, and steroid use over 5 years. The goal is to understand how the…

This study tests whether using a carotid ultrasound (a neck scan) can better prevent heart attacks and strokes in people with inflammatory rheumatic diseases like rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and lupus. These patients have a higher heart ris…

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 study is an early test of a new drug called budoprutug for people with systemic lupus erythematosus (SLE), an autoimmune disease. The main goal is to check if the drug is safe and tolerable when given as a single dose. About 30 adults with active lupus who haven't responded …

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 study tests whether a virtual group fatigue management program, combined with an informational booklet, is more effective at reducing fatigue in people with lupus than the booklet alone. Researchers will compare a 4-week and a 7-week online program. The goal is to find a pra…

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 examines specific immune cells (iNKT cells and monocytes) in people with lupus to see how they change when the disease is active versus quiet. Researchers will compare these cells in 50 adults with lupus, including those newly diagnosed or in relapse. The goal is to be…

This study looks at how the shingles vaccine (Shingrix) works in people with lupus compared to healthy people of the same age and sex. Researchers will measure immune responses after two doses and track them for up to five years. The goal is to understand if lupus or its treatmen…

This study looks at how changes in the TREX1 gene are linked to lupus severity, especially skin problems. Researchers will study 90 adults with lupus to see if certain gene patterns match worse disease. No new treatment is tested; the goal is to better understand the disease.

This study looks at how a type of cell death called ferroptosis, which is triggered by iron, may play a part in lupus. Researchers will measure certain markers in immune cells from 120 people with lupus and compare them to people with other inflammatory diseases. The goal is to b…

This study follows 700 pregnant women with lupus or antiphospholipid syndrome to see if certain proteins in the blood can predict complications like miscarriage, preterm birth, or low birth weight. Researchers will measure immune system proteins and other factors during pregnancy…

This study is a registry for people with lupus (systemic lupus erythematosus or cutaneous lupus) who are seen at Duke Rheumatology clinics. Researchers will collect medical information and blood samples from up to 1,000 participants to understand how lupus changes over time. The …

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 is a registry that follows 1,000 adults with lupus to learn more about how the disease behaves and how treatments work in everyday medical care. Participants continue their normal care with their rheumatologist, and researchers collect information during routine visits…

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 building a large registry and biorepository of 5000 adults with various rheumatic diseases like rheumatoid arthritis and lupus. Researchers will collect medical information and biological samples over time to identify patterns and biomarkers. The goal is to better u…

This study aims to test an educational tool designed for people with melanoma who also have an autoimmune disease (like rheumatoid arthritis or Crohn's disease) and are considering treatment with immune checkpoint inhibitors. Researchers will ask about 125 patients and their doct…

This study follows people with lupus and their relatives to learn how the disease starts and changes. Researchers collect medical history, blood, urine, and genetic samples to understand lupus better. The goal is to improve future treatments, not to test a new drug or cure.

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 …

This study aims to create a tool that helps doctors diagnose and choose treatments for autoimmune diseases more accurately. Researchers will analyze blood and other samples from 500 children with autoimmune conditions and healthy children to find molecular patterns. The goal is t…

This study tests a program called CO-LEAD that helps doctors and lupus patients communicate better about medications. Doctors learn special communication skills, and patients use a tool to share their medication challenges. The goal is to see if this leads to more open discussion…

This study looks at why some lupus patients get false positive results on tests for anti-HLA antibodies, which can make it harder to get an organ transplant. Researchers will study stored blood samples from 30 lupus patients who have no known risk factors for these antibodies. Th…

This study is a registry that will enroll up to 1,000 pregnant women or those planning pregnancy who have autoimmune diseases like lupus or rheumatoid arthritis. Researchers at Duke University will track their health and pregnancy outcomes to identify risk factors and find ways t…