Running out of creative ways to hide your discoid lupus?
Learn about a research study for people with skin lupus
About the Study
The HZNP-DAX-202 DLE Study is evaluating a study drug to see if it may reduce symptoms of a type of skin lupus known as discoid lupus erythematosus, or DLE. Discoid lupus commonly appears as disc-shaped sores or rashes on your face, neck, ears, scalp, hands, and feet. If you still have moderate to severe discoid lupus symptoms even with medication, or you could not tolerate your DLE medication’s side effects, this research study may be an option. Participants must have lupus that affects only their skin, not lupus that affects other organs of their body, also known as systemic lupus erythematosus (SLE).
The study drug works to reduce inflammation differently from other medications for skin lupus. It is given by subcutaneous (under the skin) injection once every 4 weeks at the study site.
The research study lasts up to 60 weeks and includes up to 16 visits to the study site. During the first part of the Study Treatment Period, there will be a 2 in 3 (66%) chance of receiving the study drug and a 1 in 3 (33%) chance of receiving a placebo. (A placebo looks like the study drug but contains no active drug.)
During the second part of the Study Treatment Period, all participants will receive active study drug. You may be able to continue taking your current skin lupus medication and use rescue medication for your skin symptoms during the research study.
You May Be Eligible to Participate if You:*
- Are 18 to 75 years old
- Have been diagnosed with discoid lupus for at least 6 months
- Currently experience moderate to severe skin symptoms related to discoid lupus
- Have tried medication for discoid lupus but it hasn’t worked well enough, or you were not able to tolerate the side effects
- Have lupus that affects only your skin, not other organs of your body
*The study team can discuss additional eligibility criteria with you.
Why Participate?
If you qualify and decide to participate, you will receive:
- All study-related care and the study drug at no charge
- Regular monitoring of your discoid lupus and overall health by physicians who specialize in discoid lupus
- The opportunity to help advance scientific knowledge about discoid lupus
Your safety while participating in the HZNP-DAX-202 DLE Study is our highest priority. If you have any questions or concerns at any point throughout the research study, a study team member is available. The study team can also tell you about their COVID-19 safety protocols.
Your participation in any research study is voluntary, and you are always free to withdraw at any time for any reason. Your privacy will be maintained throughout the research study.
About Discoid Lupus Erythematosus
Discoid lupus erythematosus (DLE) is a chronic autoimmune disease, a type of lupus that affects the skin.1,2 People who have discoid lupus get round (“discoid”) sores on their skin, typically on the face, neck, ears, scalp, hands, and feet—though the sores can appear anywhere on the body.1,2 It can also cause ulcers inside the lips.1 When the sores go away, there may be scars or skin discoloration.2 Discoid sores on the scalp may lead to hair loss.2 Symptoms may flare up then subside as discoid lupus goes into remission.1
Discoid lupus that affects only the skin, called primary discoid lupus, is rare.3 Primary discoid lupus is the condition being evaluated in the HZNP-DAX-202 DLE Study.
The exact cause of discoid lupus isn’t clear. Genetics and environmental factors may play a role.1 Exposure to the sun and cigarette smoking can cause symptoms to get worse2 as can stress, infection, and trauma.1
Those at higher risk for discoid lupus are2:
- Women (particularly in their 30s and 40s)
- Black, Asian American, Hispanic/Latino, or Native American
There is a need for more effective therapies for primary discoid lupus. One approved treatment and several unapproved ones currently exist, but these often don’t completely relieve symptoms and may have significant side effects.
References
- Discoid lupus. Healthline. Updated August 30, 2018. Accessed September 15, 2022. https://www.healthline.com/health/discoid-lupus
- Discoid lupus. Cleveland Clinic. Accessed September 15, 2022. https://my.clevelandclinic.org/health/diseases/21808-discoid-lupus
- Drenkard C, Parker S, Aspey LD, Gordon C, Helmick CG, Bao G, et al. Racial disparities in the incidence of primary chronic cutaneous lupus erythematosus in the southeastern US: The Georgia Lupus Registry. Arthritis Care Res (Hoboken). 2019;71(1):95-103. doi:10.1002/acr.23578
Frequently Asked Questions
This section will help answer some important questions you may have. The study doctor will provide more information as well and answer questions in more detail.
About the HZNP-DAX-202 DLE Study
This research study is evaluating a study drug to see if it may reduce symptoms in people with a type of skin lupus called discoid lupus erythematosus, or DLE. Participants need to have moderate to severe symptoms even with medication and cannot have lupus that affects any other organs of their body.
The study drug works to reduce inflammation differently from other medications for skin lupus. It is given by subcutaneous (under the skin) injection once every 4 weeks at the study site.
A placebo looks like the study drug but contains no active drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing. During the first part of the Study Treatment Period, there is a 2 in 3 (66%) chance you will receive the study drug and a 1 in 3 (33%) chance you will receive a placebo. During the second part of the Study Treatment Period all participants receive the study drug. You may be able to continue taking your current discoid lupus medication and use an approved rescue medication during the study as well.
The research study will last up to 60 weeks and includes up to 16 visits to the study site.
Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to participate, you will be given a document called an Informed Consent Form that provides, in writing, information on the research study’s purpose, possible benefits and risks, assessments, procedures, etc. No study-related procedures can be done until you sign the Informed Consent Form. You will have the opportunity to ask questions of the study team so you can decide if participating is right for you.
Privacy, Stopping Participation, Costs, and Permission
The information you provide will not be shared with anyone who is not directly associated with the HZNP-DAX-202 DLE Study without your permission, except as required by law or as set forth in the Informed Consent Form, the document you would sign before participating in the research study.
Yes, participation in research studies is always voluntary. If you decide to participate, you are free to withdraw at any time, for any reason, without any penalty or effect on your future medical care. If you do decide to leave the research study early, you should talk to your study doctor about leaving so that they can schedule a final evaluation.
No. However, all study-related care and the study drug will be provided at no cost. You may be reimbursed (paid back) for some of your transportation costs related to the research study. The study team can provide more information about this.
No, your doctor does not have to give you permission to participate. However, feel free to talk to your doctor about participating in the HZNP-DAX-202 DLE Study. With your permission, the study doctor will keep your regular doctor updated about your condition during the research study.
About Research Studies
A research study, also known as a clinical trial, is a scientific study that evaluates the safety and effectiveness of a study drug as well as how your body processes that drug. Qualified doctors, nurses, and other medical professionals are responsible for conducting the research study.
It is only through the completion of research studies that study drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries (such as the US Food and Drug Administration [FDA]) will provide this approval after a thorough review. In order to ensure that a research study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review the detailed plans and goals for the study.
A study drug is a drug that has not been approved for prescription use by regulatory or health authorities, such as the FDA or European Medicines Agency (EMA).
Only participants who meet all the required eligibility criteria for the research study may take part. The study team will review your medical history and current medical status against the eligibility criteria to determine if you are eligible to take part. You may also be asked to provide information from your medical records to help the study team determine whether or not you may be eligible.
Horizon Therapeutics plc is conducting this research study. Horizon is a biotechnology company headquartered in Dublin, Ireland. Its US headquarters is in Deerfield, Illinois.