What clinical trials are happening now?
Below, you’ll find clinical trials that are actively seeking eligible participants. These trials are designed to evaluate potential new treatments for lupus, and by participating, you may be taking a step closer toward feeling better or helping others like you.
Note: Clinical trials aren’t right for everyone and don’t always work for everyone. Checking your eligibility is the first step, but it doesn’t guarantee participation. Each trial has specific criteria to ensure safety and effectiveness. Before you choose to participate, you should speak with your doctor.
Could You Be Eligible for the CA061-1001 NEX-T: A CAR T Lupus Study?
This phase 1 clinical trial aims to test the safety, tolerability, and effectiveness of a new CAR T cell therapy for adults with severe, refractory systemic lupus erythematosus (SLE) (lupus that doesn’t get better with standard treatments). This study will explore the potential of using CAR T cells to target and remove specific immune cells (CD19+ B cells and plasmablasts). By doing this, it aims to bring the disease into remission and help restore the balance of the immune system.
You may qualify if you:
- Are at least 18 years old
- Have been diagnosed with SLE by a rheumatologist
- Have active lupus involving a major organ
- Have severe SLE that hasn’t responded well to standard treatments
- Do NOT have drug-induced SLE
- Have NOT had CAR T cell therapy, genetically modified T cell therapy, or a stem cell transplant
Could You Be Eligible for the POETYK SLE-1/SLE-2 Studies?
Do you or a loved one have active systemic lupus erythematosus (SLE)? These phase three studies are being done to learn if the oral pill deucravacitinib (BMS-986165) works and is safe in people with active moderate to severe SLE. Deucravacitinib is approved for moderate to severe plaque psoriasis but is not yet approved for treatment of SLE.
You may qualify if you:
- Are 18 to 75 years old
- Have been diagnosed with SLE by a rheumatologist and have a rash and/or arthritis due to lupus
- Have positive antibodies (ANA, or anti-dsDNA or anti-Smith)
- Are on treatment for lupus with an immunosuppressant, antimalarial medication, or both
- Do not have another autoimmune disease (except type I diabetes, thyroid autoimmune disease, Celiac disease, or secondary Sjogren’s syndrome)
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For a complete list of current lupus clinical trials, click here.
How can I get involved?
Considering a lupus clinical trial? Whether you’re exploring your options or ready to take the next step, our resources are designed to help you feel informed and confident in your decision.
Here are a few ways to get started:
Do Your Research
Learn what it means to be a part of a clinical trial and talk to your doctor. They can help you understand if participating in a clinical trial is a safe and appropriate option for you.
Learn More
Listen to Real-life Experiences
This podcast series offers patient-friendly insights into clinical trials — from the perspectives of a patient, a care partner, and a health care provider.
Learn More
Explore Available Trials
Use our website to browse lupus clinical trials that might be a good fit for you.
Learn MoreSubscribe for more clinical trial resources
What is it like to be a part of a clinical trial?
We’ve crafted resources for lupus patients, by lupus patients and the providers who care for them, to guide you through the clinical trial experience. These patient-driven podcasts, articles, and tips offer real-life insights into what it’s like to participate in a clinical trial — from handling day-to-day challenges to navigating the emotional journey. Whether you’re thinking about joining a trial or are already involved in one, these resources are here to give you the support and encouragement you need from those who truly understand.
EPISODE 1:
Your Guide to Lupus Clinical Trials: What the POETYK Study Could Mean for You
Lupus patient Juana Mata shares her clinical trial journey with support from her sister, Estela Mata-Carcamo. Dr. Philip Mease, a rheumatologist and principal investigator, discusses how the POETYK study may offer potential treatment options for lupus.
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EPISODE 2:
CART T Cell Therapy for Lupus: What It Could Mean for You
We explore CAR T cell therapy for lupus with experts Petra Schuberth, Senior Director of Medical Affairs at Bristol Myers Squibb, Dr. Saira Sheikh, Director of the UNC Rheumatology Lupus Clinic, and patient advocate Estela Mata-Carcamo. From eligibility to the potential risks and benefits of clinical trials, this conversation aims to equip lupus patients with the knowledge they need to discuss this emerging option with their health care providers and move beyond the status quo.
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AUDIO GUIDE 1:
Clinical Trials 101
Dr. Philip Mease explains what clinical trials involve and how they might benefit you — a great resource for anyone considering this next step on their health journey.
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AUDIO GUIDE 2:
Myths About Clinical Trials
Dr. Philip Mease breaks down common myths and answers key questions to help you understand this potential treatment path.
Listen NowThe information and perspectives shared in this podcast are based on individual patient and provider experiences and are intended for informational purposes only. Every person’s decision to enroll in a clinical trial and their experience during the trial can vary significantly. The content discussed should not be considered as medical advice and should not take the place of professional medical care. We strongly encourage you to consult your health care provider before making any decisions related to your health or participation in clinical trials. Your doctor can help you understand the potential risks and benefits, ensuring that any choices you make are appropriate for your specific medical situation.
Are clinical trials safe?
Safety is the first priority in clinical trials.
Trials are designed, conducted, and monitored according to local regulatory requirements, ethical principles, and international standards. Clinical trials are completely voluntary, and participants can leave the trial at any time, for any reason, without penalty or fees. However, if withdrawing from a trial, the participant should inform the research team.
Before participating in a clinical trial, you will need to sign an informed consent form (ICF), which outlines the purpose, procedures, risks, and benefits of the study. You will be given ample time to review the form, ask the study staff questions, and even take it home to consider or discuss with your loved ones.
Click on each question or tab to learn more about clinical trials.
Discover what clinical trials are and how they play a role in lupus research. Dr. Philip Mease explains the purpose of clinical trials, their importance in understanding lupus, and their contribution to potential treatments.
Participation in clinical trials involves understanding potential risks and benefits. Dr. Philip Mease explains how side effects are monitored, the importance of informed consent, and the role of study teams in ensuring your safety.
Clinical trials progress through distinct phases to ensure study medications are safe and effective. Dr. Philip Mease provides an overview of each phase, from pre-clinical testing in laboratories to post-approval studies in Phase IV.
Clinical trials have specific eligibility requirements to ensure safety and effectiveness. In this video, Dr. Philip Mease guides you through the eligibility criteria, screening processes, and the steps taken to determine if a trial might be right for you.
What are clinical trials?
Clinical trials, also known as clinical studies, are research studies that include human participants. These trials investigate how a study drug might act in the body and affect a disease. It is important that these studies make sure to evaluate the safety of the study drugs so you can take it.
Clinical trials are crucial for lupus patients as they help researchers understand the disease better and aim to develop potential treatments. Participation in clinical trials can lead to advancements in medical knowledge and new therapies for lupus.
Clinical trials are designed to help you possibly get closer to your goal of remission and be considered as an option in your toolkit. Enrolling in a clinical trial is a decision that you should make in consultation with your doctor and your loved ones.
What are the phases of clinical trials?
Clinical studies are typically classified into the following phases:
- Pre-clinical: When study medications are tested in the laboratory and on animals
- Phase I: Researchers test study medication for the first time in humans by giving it to a small number (20-80). And these can be either patients with a disease or healthy volunteers to evaluate how the drug works and identify potential side effects.
- Phase II: The study drug is given to a larger number of people (100-300) with a particular disease or condition to further evaluate safety, side effects, and the drug’s efficacy.
- Phase III: Several hundred to several thousand people with the disease or condition participate. The study drug undergoes additional testing to continue to assess safety, side effects, and efficacy or how well the medication works optimal dosage, and comparison to standard treatments.
- Phase IV: Conducted after the study medication is approved and available by prescription, researchers aim to understand the best way to use the study medication as a potential treatment and identify any other risks or benefits.
What questions should I ask before participating?
It’s important to get informed and get as much information as possible before participating in a clinical trial. Key questions to ask:
- Are you a good candidate for the study?
- Do you qualify for the study?
- How long will the study last?
- Does it include any study treatment?
- How long are the visits?
- How many times do you have to go in to see your provider?
- Will you know whether the study medication or study treatment is being given to you?
- What questions should you ask regarding the consent forms?
- What is required of you as a participant in the study?
- Will you be compensated for participating in the study?
- Will you be reimbursed for any travel expenses or other costs related to the study?
What are the potential benefits of joining a clinical trial?
The benefits of participating in a clinical trial are numerous. These can include access to study medication that is not yet approved for your disease. In addition, clinical trials offer close monitoring and care from health care professionals, and by participating, you are contributing to medical research that could potentially help your peers in the future.
However, it’s important to understand that there may not be any direct benefit to you from taking part in a clinical trial.
What are the possible risks?
Keep in mind that each person’s experience is unique. Some people may experience risks, while others may not. Just like any other medical decision you make, it’s crucial to have a clear understanding of the risks when contemplating a clinical trial. Here are some important ones to discuss with your doctor.
- New treatments may have unexpected side effects and risks that are worse than that of the standard option of care.
- Costs that a participant may have as a result of the study might not be covered by health insurance and managed care providers.
- Even if you are seeing positive effects from the intervention, the intervention may not be approved by regulatory agencies.
- Participants in randomized trials are assigned whether or not they will receive an intervention that is being tested. They cannot choose. “Randomized” means that a person is randomly assigned to an intervention group to receive treatment or to a control group to receive a “placebo” or usual care.
- Additional doctor visits may be required.
Are clinical trials open to everyone?
Participation in clinical trials is open to people of various ages and backgrounds. However, each research study has specific eligibility requirements based on factors, such as age, gender, type, and stage of disease, previous or current treatments, and other medical conditions. Your eligibility will ultimately be determined by the study doctor.
Every potential clinical trial participant must also go through a screening process to ensure they meet the eligibility requirements. The screening process may include more than one visit.
- Pre-screening assessment: This initial screening may take place over a phone call or you may fill out a questionnaire online. You’ll be asked general information such as your age, race, preferred contact method, and to verify your contact details. You’ll also discuss your current diagnosis as well as any comorbidities that you’re living with that could exclude you from the study. You may also be asked about the medications you are taking. When filling out forms or answering questions, it’s important to be honest. Don’t answer based on what you think might make you eligible. The information you share is designed to help determine if the trial would benefit you.
- Screening appointment: If you pass the pre-screening, you’ll be invited for an in-person evaluation. During this visit, the study team will explain the trial, ask you to review and sign the informed consent form, and discuss all inclusion and exclusion criteria. You’ll also undergo a physical examination, which may include height, weight, temperature, blood pressure, and blood and urine tests. Additional tests may be conducted based on your medical history. The screening period will vary in the number of visits based on the study.
Why is diversity in clinical trials important?
Diversity in clinical trials is essential to developing better treatments for lupus. These trials help researchers understand what works, what doesn’t, and how to make care safer and more effective. However, if people from all backgrounds aren’t included, the results might not reflect the needs of those most affected by lupus. Lupus is a complex autoimmune disease that impacts people differently based on factors like gender, race, ethnicity, and even where they live.
New treatments are urgently needed to improve the lives of those living with lupus. Without diverse participation, researchers could miss how treatments work — or don’t work — for everyone.
This project was made possible with support from Bristol Myers Squibb.
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The information and perspectives shared are based on individual patient and provider experiences and are intended for informational purposes only. Every person’s decision to enroll in a clinical trial and their experience during the trial can vary significantly. The content discussed should not be considered as medical advice and should not take the place of professional medical care. We strongly encourage you to consult your health care provider before making any decisions related to your health or participation in clinical trials. Your doctor can help you understand the potential risks and benefits, ensuring that any choices you make are appropriate for your specific medical situation..
