The SLEek Study will include about 325 patients with a diagnosis of Systemic Lupus Erythematosus (SLE) and will be conducted at approximately 140 study sites worldwide. All study-related care will be provided by a Rheumatologist.

If you qualify for the study, you will visit a study clinic in your area approximately 15 times over 48 weeks.

The study will be evaluating the effectiveness of an oral (in a pill) investigational study drug for SLE.  Volunteers who qualify to take part in the study may receive compensation for time and travel expenses.

  • 1
    If you are between the ages 18 and 65 and have been diagnosed with Systemic Lupus Erythematosus (SLE) you may be able to participate.
  • 2
    All study-related care is provided at no cost. You do not need health insurance to participate.
  • 3
    Volunteers who take part in the study may be eligible to receive compensation for their time and travel.
  • 4
    Participants will receive all study-related care from a Rheumatologist at no cost. The study will require approximately 15 visits over 48 weeks to a research center in your area.

Who can take part in the SLEek Study?

You may be able to take part in the study if you:

  • 1
    have a diagnosis of Systemic Lupus Erythematosus (SLE)
  • 2
    are between the ages of 18 and 65
  • 3
    have had a diagnosis of SLE for at least six months

All study-related care will be provided by a Rheumatologist.

SEE IF YOU QUALIFY
Participate
Participate
Volunteers who take part in the study may be eligible to receive compensation for their time and travel.
Participate

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. 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
  • Ulcers
  • Weight Loss
  • Skin Rashes
  • Photosensitivity (in SLE, photosensitivity refers to developing new or larger rashes when exposed to the sun)

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 SLEek Study is investigating an oral medication to help treat the signs and symptoms of the disease.

References: [1] https://www.lupus.org/resources/lupus-facts-and-statistics [2] https://medlineplus.gov/ency/article/000435.htm

Frequently Asked Questions

What is a Clinical research study?

A Clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug or device, such as: Does the treatment work or how safe and effective it is compared to other drugs/devices?

If you qualify and decide to join the SLEek study, you will visit a research site in your area approximately 15 times over 48 weeks.

You will continue your current Lupus treatment and will also be randomly assigned (assigned by chance) to receive the oral investigational study drug or a placebo (looks like the study drug but does not contain any active ingredients).

You have an 80% chance of receiving the study drug and a 20% chance of receiving the placebo.

Because this study is double-blind, neither you nor your study team will know which group you’ve been placed into.

If you complete the trial, there is a plan for a long-term extension study where 100% of participants will receive the active study drug (alongside your current treatment) and be monitored.

If you choose to participate in the SLEek Study, at visits, you will undergo general physical examination procedures to assess your wellbeing (e.g. height, weight, blood pressure) and the activity of your SLE. You will also undergo blood draws to check your laboratory test values.

All study-related care is provided at no cost to you. You do not need health insurance to participate.
Participation is entirely voluntary. Even if you decide to take part in this study, you can change your mind about participating at any time.

If you qualify and decide to join the SLEek study you will continue your current Lupus treatment. In addition, you will also be randomly assigned (assigned by chance) to receive the oral active investigational study drug or a placebo (looks like the study drug but does not contain any active ingredients).

You have an 80% chance of receiving the study drug and a 20% chance of receiving the placebo.
If you participate in the long-term extension study, you will remain on your current Lupus treatment and have a 100% chance of receiving the active oral investigational study drug.

There is a 20% chance you may be assigned to the placebo group of the trial. Regardless of what study treatment group you are assigned to, you will always be required to maintain your current background treatment for SLE throughout the trial.

In addition, if you complete the trial, there is a plan for a long-term extension study where 100% of participants will receive the active study drug (alongside your current treatment) and be monitored.

Volunteers who take part in the study may be compensated for travel costs and time in the study. Please discuss this with the study team when they contact you.

There is no cost to participate in the SLEek Study. The study medication, study-related tests, assessments, and visits will be provided at no cost to you and your insurance company. If you decide to take part in the study, you will receive study-related care throughout the study from a Rheumatologist.

The research team will be able to explain more about what the SLEek Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.

There are risks and benefits of taking part in any clinical study. For example, your health may be more closely monitored than it would have been otherwise. You may also benefit from taking the oral investigational drug, though this is not guaranteed. The known risks and benefits of participation are outlined in the informed consent form (ICF) that you must read and sign before you can take part in this study. 

We match you to a research center within a close travel distance from your home. If we are not currently running any trials in your area, we will keep you in our database and reach out to you once a study in your area becomes available. 

Sign Up

What happens if I Sign Up?If you sign up, we will match you to a study clinic in your area that is seeking participants or notify you when one becomes available. They will contact you to explain more about the study before you make your decision about participating. You will attend an in-person visit where the study team will help determine if you qualify and if the study is right for you.

If you think you might like to join the SLEek Study or would like more information, please enter your information below so we can see if you qualify and can contact you about the study.