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A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
What are clinical trials for lupus?
Lupus clinical trials are research studies used by medical professionals to evaluate new treatments, therapies, or approaches to managing lupus, an autoimmune disease where the immune system attacks the body's own tissues. These trials aim to discover more effective ways to treat lupus, manage symptoms, and improve patients' quality of life. Clinical trials for lupus may involve testing new medications, biologics, or combinations of existing treatments, as well as exploring lifestyle interventions or preventive strategies.
Why are lupus clinical trials important?
Clinical trials for lupus are important because they drive the development of more effective and safer treatments for this complex autoimmune disease, which currently has limited options and often involves side effects for patients. These trials help researchers better understand lupus, including its triggers and progression, leading to improved management strategies. By testing new therapies, clinical trials for lupus offer hope for reducing symptoms, preventing flare-ups, and improving the quality of life for those affected.
What types of clinical trials are used for lupus?
Researchers have a variety of options when it comes to designing a lupus clinical trial. Their choice will depend on the objectives of the trial and the kind of information they are seeking to find.
Interventional trials
Interventional trials in lupus research are used to test new treatments, therapies, or interventions by actively administering them to participants. These trials aim to determine the effectiveness, safety, and optimal dosages of new drugs, biologics, or treatment strategies compared to existing options or placebos.
Researchers may use randomized controlled trials (RCTs) as part of the study, where participants are assigned to either a treatment group or placebo group to test the effectiveness and safety of medications.
earn more about randomization in clinical trials? Read all about its essential role in ensuring unbiased results, the different methods used to implement randomization, and how it impacts the reliability and validity of clinical research in our detailed guide.
Participants receive the experimental treatment under close medical supervision, with regular monitoring to assess how well it works and to identify any side effects. The data collected from these trials help researchers develop more effective therapies, improve patient outcomes, and potentially introduce new treatment options that can better manage lupus symptoms and reduce disease activity.
Observational trials
Clinical research teams can use observational trials for lupus. In these trials, researchers monitor patients over time to gather data on the natural history of the disease, its progression, and how current treatments are working in real-world settings. Unlike interventional trials, observational studies do not involve administering new treatments but instead focus on collecting information about patient experiences, symptoms, and outcomes.
Data from observational trials helps researchers identify patterns, risk factors, and potential areas for improvement in lupus management. The insights gained from these trials contribute to a deeper understanding of the disease and inform future research and clinical practices, ultimately aiming to enhance patient care.
Genetic and biomarker studies
As an autoimmune condition, researchers often use genetic and biomarker studies in lupus clinical trials to focus on understanding the genetic factors and biological markers that influence the disease's onset, progression, and response to treatment. By analyzing patients' genetic profiles and identifying specific biomarkers, like proteins, antibodies, or other molecules linked to lupus, researchers can learn more about the underlying mechanisms of the disease.
Genetic and biomarker studies help identify which patients are more likely to develop lupus, how the disease may progress, and which treatments might be most effective for individual patients. The insights gained from these studies contribute to the development of personalized medicine, where treatments are tailored to a patient's unique genetic and biomarker profile, leading to more targeted and effective therapies.
Why participate in a clinical trial for lupus?
There are several compelling reasons to consider participating in a clinical trial for lupus. While taking part can provide significant benefits, it's important to be aware that there may also be some risks involved.
Participant benefits
Participating in a clinical trial for lupus offers many benefits for those taking part, including access to cutting-edge treatments and therapies that may not be available outside the trial. Participants receive close monitoring and personalized care from specialized medical teams, which can lead to early detection of side effects and more tailored treatment adjustments. This care is also often better than the current care a person is receiving as standard, as researchers have a vested interest in the condition and study results.
Additionally, being part of a trial allows patients to contribute to vital research that could advance the understanding of lupus and help develop better treatments in the future. For some, these innovative therapies may provide more effective symptom management and an improved quality of life.
Risks and considerations
Like many clinical trials, lupus trials also have some risks and considerations for participants. The most significant risk is the potential for experiencing unknown side effects or adverse reactions to the experimental treatment, which may differ from those associated with standard therapies. There is also no guarantee that the treatment will be effective, and it may not improve symptoms. In some cases, it could even worsen the condition.
Participants may need to follow strict study protocols, including frequent medical visits and tests, which can be time-consuming and inconvenient. Emotional stress can also be a factor, given the uncertainty surrounding experimental treatments.
Who can participate in a clinical trial for lupus?
The main criteria for participating in a clinical trial for lupus is individuals diagnosed with lupus or those at high risk of developing the disease. Other more specific criteria can vary depending on the trial's focus but often considers factors like the type and severity of lupus, current health status, and previous treatments.
Some trials may be open to those with specific symptoms, organ involvement, or certain demographic characteristics, such as age or gender too. Healthy volunteers may also be included in some trials for comparison purposes.
What to expect when participating in a lupus clinical trial
When participating in a clinical trial for lupus, you can expect to go through a detailed screening process to determine your eligibility and provide informed consent, which involves understanding the trial's purpose, procedures, risks, and benefits. If accepted onto the trial, you may either receive the experimental treatment, a placebo, or standard care, depending on the type of trial design.
You can also expect to be closely monitored through regular medical visits, tests, and assessments to evaluate the treatment's effectiveness and safety. You may need to adhere to specific protocols and there is a possibility of experiencing unknown side effects or symptom improvement.
How to enroll in a lupus clinical trial
Enrolling in a clinical trial studying lupus through our platform is a straightforward and user-friendly process. Here's how to get started:
- Identify Your Trial: Use our intuitive search bar or filter options to locate clinical trials specific to requirements. This first step simplifies the process of finding relevant research studies tailored to your needs.
- Select Your Preferred Location: To find trials conveniently located near you, simply input your preferred location into the dedicated filter bar on the left-hand side of the page.
- Explore Study Details: For in-depth information about each study, simply click the “Learn More” button. This will provide you with comprehensive details about the trial, including objectives, procedures, and eligibility criteria.
- Complete the Health Profile: After clicking on the “Get started” button you will be taken to our efficient 5-step application process to provide important health information. This helps us match you with the clinical trial that best fits your needs.
- Submit the Application: After completing the application, send it in. A clinical trial coordinator will review it and contact you regarding the possibility of participation.