Your lupus nephritis
symptoms may be invisible, but we see you.
Learn about a lupus nephritis research study for an investigational drug that may help prevent your symptoms from worsening.
About the HZNP-DAX-203 LN Study
The HZNP-DAX-203 LN Study is evaluating the safety and efficacy of a study drug for active nephritis, a type of lupus that affects your kidneys.
The study drug works differently from other medications for lupus nephritis to reduce inflammation. In this research study, the study drug will be given by subcutaneous (under the skin) injection at the study site. In addition to receiving the study drug or the placebo, all participants will receive a standard approved medication for lupus nephritis. The standard of care for LN will consist of the combination of mycophenolate mofetil/mycophenolic acid and corticosteroids. Over time, your corticosteroid dose will be reduced.
Mycophenolate mofetil is not approved for LN in certain countries/regions but is being used off-label due to proven efficacy and specific treatment guidelines. Taking other treatments for lupus nephritis is prohibited during the trial except in cases of worsening disease.
The research study lasts up to 116 weeks (or about 2.5 years) and includes up to 30 visits (about once per month) to the study site. Some study visits may be done by telephone or telehealth. The study team can give you more information about study visits.
You may be eligible to participate if you:*
- Are aged 18 to 80 years
- Have been diagnosed with lupus nephritis and are currently experiencing symptoms
- Have had a kidney biopsy within the last 6 months or are willing to undergo a biopsy
- Have not had dialysis within the last 12 months—or do not expect to need dialysis within the next 12 months
- Do not have a kidney disease other than lupus nephritis
*The study team can discuss additional eligibility criteria with you.
Why Participate
If you qualify and decide to take part, you will receive:
- All study-related care and the study drug at no charge
- Regular monitoring of your lupus nephritis and overall health by physicians who specialize in lupus nephritis
- Reimbursement for transportation costs to attend study visits, as needed
- The opportunity to contribute to advancing scientific knowledge about lupus nephritis
Your safety while participating in the HZNP-DAX-203 LN Study is our highest priority. If you have any questions or concerns at any point throughout this 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.
Living With Lupus Nephritis
Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE). It occurs when the immune system attacks the kidneys, leading to inflammation and possibly organ damage and kidney failure. Your symptoms in the early stages of LN may go unnoticed, but if left untreated, symptoms can worsen and eventually lead to kidney failure. At that point, dialysis or a kidney transplant might be needed.1
Common symptoms of lupus nephritis may include:1-3
- Weight gain
- Swelling of legs, feet, or ankles
- Blood and foamy appearance in the urine
- Frequent urination, especially at night
- High blood pressure
It is important to work closely with your doctor to help manage your lupus nephritis symptoms.
References
- What is lupus nephritis? Lupus Foundation of America. Updated January 23, 2021. Accessed November 1, 2022. https://www.lupus.org/resources/what-is-lupus-nephritis
- Facts about lupus nephritis. National Kidney Foundation. Accessed November 1, 2022. https://www.kidney.org/sites/default/files/nkf_al_factsheet_web.pdf
- Lupus nephritis: symptoms, treatment and complications. American Kidney Fund. Accessed November 1, 2022. https://www.kidneyfund.org/all-about-kidneys/other-kidney-diseases/lupus-nephritis-symptoms-treatment-and-complications
Frequently Asked Questions
This section will help answer some important questions you may have.
About the HZNP-DAX-203 LN Study
This research study is being done to determine the safety and efficacy of a study drug for active lupus nephritis, a type of lupus that affects your kidneys.
The study drug works differently from other medications for lupus nephritis to reduce inflammation. It will be given by subcutaneous (under the skin) injection 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. In addition to receiving the study drug or the placebo, all participants will receive an approved medication for lupus nephritis during the study, which will consist of the combination of mycophenolate mofetil/mycophenolic acid and corticosteroids.
The research study lasts up to 116 weeks (or about 2.5 years) and includes up to 30 visits (about once per month) to the study site. Some study visits may be done by telephone or telehealth.
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, and more. 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-203 LN 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 charge. You will be reimbursed (paid back) for your transportation costs to attend study visits, as needed. 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-203 LN 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 efficacy 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 efficacious, 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. 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.