We are inviting you to take part in a research study investigating the effectiveness and safety of a study drug in adults with active systemic lupus erythematosus (SLE).
The POETYK Lupus Study will include 14 visits to a research center throughout the 56-week duration of the study. This study involves taking an oral study drug, which is already approved for use in the United States and Canada and some countries in Europe to treat moderate to severe Plaque Psoriasis. The study drug has not been approved to treat SLE. Patients may be able to stay on some or all of their current SLE care treatments/medications.
Participants will receive the study medication or a placebo (a pill that looks like the study medication but has no active ingredient) at no cost while enrolled in the study. Participants will not be responsible for study-related costs such as visits, lab tests, and procedures. No health insurance is required to participate in the study. You may also be eligible for compensation for your time as well as reimbursement for some costs such as travel, transportation, and meals incurred based on your participation in the trial.
You may qualify for the POETYK Lupus Study if you:
- Are 18 to 75 years of age
- Have a diagnosis of active systemic lupus erythematosus (SLE)
- Have not been diagnosed with other autoimmune diseases (for example, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.)
Sign Up to see if you Pre-qualify
What happens if I sign up? If you pre-qualify, we will match you to a nearby research study location that needs volunteers with Systemic Lupus Erythematosus (SLE) or notify you when one becomes available. The study may reimburse for travel and/or provide compensation so if you are interested and there is not a site near you, we can still connect you to a research site. The study team will then contact you and you may have the opportunity to participate if you qualify.
If you think you might like to participate in the POETYK Lupus Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the studies. Keep in mind that participation is entirely voluntary. If you do decide to take part in a study, you may change your mind about participating at any time.
About Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is an autoimmune disease that causes the body to mistakenly attack healthy tissue. SLE typically affects the skin, joints, kidneys and brain.
The cause of SLE is not well-known, however women are more likely to be affected than men.1 SLE can occur at any age. There are factors that may be linked to Systemic Lupus Erythematosus such as:
- Genetic
- Environmental
- Hormonal
Almost everyone with SLE experiences joint pain and swelling, but other symptoms may vary person to person. It is common for Systemic Lupus Erythematosus to affect the joints of the hands, knees and wrists.2 Other symptoms may include:
- Fatigue
- Fever
- Hair Loss
- Photosensitivity (in SLE, photosensitivity refers to developing new or larger rashes when exposed to the sun)
- Ulcers
- Weight Loss
- Skin Rashes
Although there is no cure for SLE, the goal of treatment is to ease symptoms and prevent future damage. Treatment plans will vary depending on the individual's case. The POETYK Lupus Study is investigating the effectiveness and safety of a study drug in adults with active systemic lupus erythematosus (SLE).
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications, such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of the POETYK Lupus Study?
The POETYK Lupus Study is investigating the effectiveness and safety of a study drug in adults with active systemic lupus erythematosus (SLE).
What will the POETYK Lupus Study involve?
The POETYK Lupus Study begins with a screening visit. If you meet all eligibility criteria, you may be randomized to receive one of two study treatments and will be expected to attend regular in-person study visits every four weeks during the double-blind period, which will last up to 56 weeks. After the double-blind period ends, you may enter the LTE period and receive the study medication, with study visits every four to 12 weeks, which will last up to 164 weeks.
This study involves taking an oral study drug, which is already approved for use in the United States and Canada and some countries to treat moderate to severe Plaque Psoriasis. Patients may be able to stay on some or all of their current SLE care treatments/medications while taking part.
What else do I need to consider?
The research team will be able to explain more about what the POETYK Lupus Study will involve. It is up to you to decide if you want to take part. Participation in this study is voluntary. If you decide to participate, we expect your doctor and the study doctor to stay in communication. You can continue to go to your doctor as well while in the study. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the research center?
We will match you to a research center that is the closest travel distance from your home. Since travel reimbursement is included for most sites, we hope you will be willing to participate even if this site is not close. If you are unwilling to travel to a site on the study, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your details.
About the POETYK Lupus Study
The POETYK Lupus Study begins with a screening visit. If you meet all eligibility criteria, you may be randomized to receive one of two study treatments and will be expected to attend regular in-person study visits every four weeks during the double-blind period. After the double-blind period ends, you may enter the Long Term Extension (LTE) period and receive the study medication at no cost for up to two years, with study visits every four to twelve weeks.
This study involves taking an oral study drug, which is already approved for use in the United States, Canada, and some additional countries to treat moderate to severe plaque psoriasis. The study drug has not been approved to treat SLE. Patients may be able to stay on some or all of their current SLE care treatments/medications while taking part.
Participants will receive the study medication or a placebo (a pill that looks like the study medication but has no active ingredient) at no cost while enrolled in the study. Additionally, participants will not be responsible for study-related costs such as visits, lab tests, and procedures. Participants may also be eligible for compensation and or reimbursement for some costs, such as travel or transportation, depending on location. No health insurance is required to participate in the study.
The POETYK Lupus Study is investigating the effectiveness and safety of a study drug in adults with active systemic lupus erythematosus (SLE).
Who can take part in the POETYK Lupus Study?
You may qualify for the POETYK Lupus Study if you:
- Are 18 to 75 years of age
- Have a diagnosis of active systemic lupus erythematosus (SLE)
- Have not been diagnosed with other autoimmune diseases (for example, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.)
