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70 Systemic Lupus Erythematosus Trials
Power is an online platform that helps thousands of Systemic Lupus Erythematosus patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Efgartigimod for Myositis
Columbus, OhioThis trial is testing an injectable medication called efgartigimod PH20 SC in people with certain muscle inflammation diseases. The goal is to see if it helps improve their condition by lowering harmful proteins in their blood. The study focuses on patients with specific subtypes of these diseases who often don't respond well to usual treatments. Efgartigimod was developed for autoimmune diseases and has been approved for treating a specific muscle condition in adults.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Infection, Autoimmune Disease, Malignancy, Others
240 Participants Needed
N-acetylcysteine for Lupus
Columbus, OhioSystemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side-effects. We previously discovered the depletion of glutathione in lymphocytes of patients with SLE and associated this metabolic change with the elevation of the mitochondrial transmembrane potential.
This study will titrate to tolerance during an initial 3 month open label period and then subjects will be randomized to one of 2 arms.
It was determined by statistical analysis that each group must have 105 subjects. All subjects will be enrolled and evaluated for tolerance of NAC between dosages of 2.4 g/day and 4.8 g/day for 3 months. After A 3-month open-label dose-titration phase, SLE subjects will be randomized into 2 groups of 105 subjects either to continue the tolerated dosage of NAC or switched to equal number of placebo capsules. There will be up to seven study visits per SLE subject, including the screening and wash out visits. Visits 2-6 will be scheduled three months apart. The study will last 13 months with the wash-out visit. Each subject will donate approximately 100 ml of blood for biomarker studies at each visit. Healthy control subjects will donate blood at the same time. They will be matched to the SLE subjects by gender, age within 10 years, and ethnicity. Their blood will be used as reference for biomarker assays.
There is a consent form required to participate in the phase II study.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Acute SLE Flare, Pregnancy, Serious Comorbidities, Active Infections, Others
Must Be Taking:Immunosuppressants, Antimalarials, Corticosteroids
290 Participants Needed
Felzartamab for Lupus Nephritis
Columbus, OhioThe goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Rapidly Progressive Glomerulonephritis, Dialysis, Kidney Transplant, Others
20 Participants Needed
CUG252 for Lupus
Columbus, OhioThis trial tests CUG252, a new medicine for people with Systemic Lupus Erythematosus (SLE). It aims to enhance beneficial immune cells while reducing unwanted immune activity. The study will check its safety and effectiveness over time.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
40 Participants Needed
Obinutuzumab for Lupus
Columbus, OhioThis trial is testing a medication called obinutuzumab in people with active lupus who have specific antibodies in their blood. These patients are already on standard treatments but need more help. The medication works by reducing harmful immune cells that cause inflammation and damage.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
300 Participants Needed
M5049 for Lupus
Columbus, OhioThis trial involves taking a pill called M5049. It targets patients with specific types of lupus who have already been treated for several months. The goal is to check if the pill is safe and works well over a longer time.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 76
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Infections, Psychiatric Conditions, Others
532 Participants Needed
Deucravacitinib for Cutaneous Lupus Erythematosus
Columbus, OhioThis trial is testing a new medication called deucravacitinib to help people with certain types of lupus that aren't well managed by current treatments. The medication works by calming the immune system to reduce skin damage.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
75 Participants Needed
BAFF CAR-T Cells for Lupus
Columbus, OhioThis phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
18 Participants Needed
Anifrolumab for Lupus
Columbus, OhioA Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Hepatitis C, Others
Must Not Be Taking:Cytotoxic B-cell Depleters
100 Participants Needed
Afimetoran for Lupus
Columbus, OhioThis trial is testing a new medication called Afimetoran to help people with active Systemic Lupus Erythematosus (SLE). The goal is to see if it can safely reduce symptoms by calming down the immune system. The study will also provide data on its effectiveness and safety over time.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Lupus Nephritis, Neuropsychiatric Lupus, Mixed Connective Tissue Disease, Antiphospholipid Syndrome
268 Participants Needed
CC-97540 for Severe Refractory Lupus
Columbus, OhioThis trial is testing a new drug called CC-97540. It aims to help people with severe autoimmune diseases that don't get better with regular treatments. Researchers want to see if the drug is safe, how it moves through the body, and if it can improve patients' health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Drug-induced SLE, Multiple Sclerosis, Psoriasis, Others
129 Participants Needed
Emapalumab for MAS in Still's Disease or Lupus
Columbus, OhioThis trial is testing emapalumab, a medication that helps control an overactive immune system, in children and adults with certain immune conditions who haven't responded to high-dose steroids. The goal is to see if it is safe and effective in reducing excessive inflammation. Emapalumab is a monoclonal antibody that targets interferon-γ and was first approved for treating primary hemophagocytic lymphohistiocytosis (HLH) in patients with refractory, recurrent, or progressive disease.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6 - 80
Sex:All
41 Participants Needed
Nivolumab for Cancer
Columbus, OhioThis phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Chemotherapy, Radiotherapy, Allogeneic Transplant, Others
Must Not Be Taking:Anticancer Investigational Agents
300 Participants Needed
Litifilimab for Cutaneous Lupus Erythematosus
Columbus, OhioThis trial is testing BIIB059, a new medicine that targets specific immune cells, in patients with skin lupus who haven't responded to standard treatments. The goal is to see if it can reduce their skin symptoms by calming down these immune cells.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Skin Conditions, Mixed Connective Tissue Disease, Severe Lupus Nephritis, Active Neuropsychiatric SLE, Others
Must Not Be Taking:Intralesional Corticosteroids, Immunosuppressives
474 Participants Needed
Daxdilimab for Discoid Lupus
Columbus, OhioThis trial tests daxdilimab, an injectable medication, in patients with severe skin lupus who haven't improved with standard treatments. The drug works by calming the immune system to reduce skin symptoms.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
72 Participants Needed
Empasiprubart for Dermatomyositis
Dayton, OhioThis study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).
The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Malignancy, Infection, Others
42 Participants Needed
Ianalumab for Lupus
Dayton, OhioThe trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 100
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Infections, Hepatitis B/C, HIV, Others
Must Be Taking:CS, Anti-malarials, DMARDs
406 Participants Needed
Litifilimab for Lupus
Dayton, OhioThis trial is testing litifilimab, a medication for people with active systemic lupus erythematosus (SLE). It aims to see if the drug can safely reduce the immune system's attack on the body, helping to manage symptoms and prevent organ damage. Litifilimab has shown promise in reducing the number of swollen and tender joints in SLE patients.
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:18+
Sex:All
864 Participants Needed
Belimumab for Lupus
Cincinnati, OhioThis trial is testing a medication called belimumab, given as an injection under the skin, in children with lupus. The goal is to see if it is safe and effective by calming down their overactive immune systems. Belimumab is approved for the treatment of lupus in adults with moderate disease activity.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:5 - 17
Sex:All
25 Participants Needed
Brepocitinib for Dermatomyositis
Cincinnati, OhioThis trial tests brepocitinib, a drug that blocks inflammation-causing proteins, in adults with dermatomyositis. The goal is to see if it improves symptoms like muscle weakness and skin rashes by reducing inflammation. Another similar drug has shown positive results in treating difficult cases of dermatomyositis.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
241 Participants Needed
Ianalumab + Standard Therapy for Lupus Nephritis
Cincinnati, OhioThis trial will test how well ianalumab injections work and how safe they are for adults with a type of kidney inflammation caused by lupus. The medication is given under the skin at regular intervals. It aims to reduce kidney inflammation by calming the immune system.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 100
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Renal Impairment, Transplant History, Active Infections, Others
Must Be Taking:Corticosteroids, MPA
420 Participants Needed
IMPT-514 for Lupus
Cincinnati, OhioThis is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active, refractory lupus nephritis and systemic lupus erythematosus.
IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 1 year.
Participants will continue in long-term follow-up for 15 years from treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
30 Participants Needed
Coping Skills Program for Lupus
Cincinnati, OhioThis study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 22
Sex:All
Key Eligibility Criteria
Disqualifiers:Juvenile Arthritis, Developmental Delay, Others
196 Participants Needed
Fitness Training for Juvenile Arthritis
Cincinnati, OhioThis study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and neuromuscular exercise training program in patients with pediatric rheumatic diseases and/or joint hypermobility.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 19
Sex:All
Key Eligibility Criteria
Disqualifiers:Major Psychiatric Diagnoses, Developmental Delay, Others
20 Participants Needed
Upadacitinib for Lupus
Cincinnati, OhioSystemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed.
Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world.
Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 63
Sex:All
Key Eligibility Criteria
Disqualifiers:Lupus Nephritis, Neuropsychiatric SLE, Overlap Syndromes, Others
Must Be Taking:Antimalarials, Corticosteroids, Immunosuppressants
1000 Participants Needed
Belimumab for Pediatric Lupus
Cincinnati, OhioThis is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:5 - 17
Sex:All
93 Participants Needed
CB-010 for Lupus
Cincinnati, OhioThis is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
20 Participants Needed
Ianalumab for Autoimmune Diseases
Middleburg Heights, OhioThe purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Infections, Live Vaccines, Pregnancy, Others
140 Participants Needed
Litifilimab for Lupus
Middleburg Heights, OhioIn this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:
- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS).
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.
The study will be done as follows:
* After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
* All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Hepatitis C, Others
Must Be Taking:Antimalarials, Steroids, Immunosuppressants
540 Participants Needed
Anifrolumab for Lupus Nephritis
Middleburg Heights, OhioThis trial is testing an IV medication called anifrolumab in adults with severe lupus nephritis. The goal is to see if it can reduce inflammation and prevent kidney damage. All patients will also receive standard treatments. Anifrolumab is approved by the FDA for treating moderate to severe systemic lupus erythematosus (SLE).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, Cancer, Others
Must Not Be Taking:Cyclophosphamide, MMF, Tacrolimus, Others
360 Participants Needed
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Frequently Asked Questions
How much do Systemic Lupus Erythematosus clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Systemic Lupus Erythematosus clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Systemic Lupus Erythematosus trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Systemic Lupus Erythematosus is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Systemic Lupus Erythematosus medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Systemic Lupus Erythematosus clinical trials ?
Most recently, we added AZD5492 for Lupus and Myositis, CB-010 for Lupus and Sodium Thiosulfate for Calcinosis to the Power online platform.