Join us in our mission to improve the lives of those with lupus nephritis.

The PALIZADE Phase 2b clinical trial is enrolling people living with lupus nephritis.

Zetomipzomib (KZR-616) is an investigational product and has not been approved for commercial use in the United States or any other country for any indication.

Get Started

Join us in our mission to improve the lives of those with lupus nephritis.

The PALIZADE Phase 2b clinical trial is enrolling people living with lupus nephritis.

Learn More

Zetomipzomib (KZR-616) is an investigational product and has not been approved for commercial use in the United States or any other country for any indication.

The PALIZADE Clinical Trial

PALIZADE is a global, placebo-controlled, double-blind Phase 2b clinical trial comparing the efficacy and safety of zetomipzomib (KZR-616) with placebo in people living with active lupus nephritis.

ClinicalTrials.gov

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The PALIZADE clinical trial will evaluate zetomipzomib as a potential new treatment for adults living with lupus nephritis. Kezar Life Sciences is conducting this trial to assess zetomipzomib for the treatment of lupus nephritis, its side effects, and how it affects proteins in the urine and blood. Zetomipzomib is a first-in-class, investigational product and has not been approved for commercial use.

Lupus nephritis is a serious manifestation of systemic lupus erythematosus (SLE), commonly referred to as lupus, an autoimmune disease that damages the kidneys’ ability to filter out waste.¹
While there are several medications used for the treatment of lupus nephritis, these may only be effective for some people. They may also result in serious side effects, including an increased risk of infection.^2,3 Kezar Life Sciences is conducting the PALIZADE clinical trial to determine if zetomipzomib may be safe and effective for the treatment of lupus nephritis.

WHAT to Expect: Step-by-Step Process

After talking with your doctor and selecting a participating physician, you will then go through an informed consent process, in which the investigating physician explains the clinical trial to you in detail, ensures you understand the risks and requirements of participating, and gives you a chance to ask questions.

You will also be given written materials that provide additional clinical trial details to read and consider. If you want to participate and are deemed eligible, you must sign the consent form to give your permission to be included in the clinical trial.

The PALIZADE clinical trial is made up of 3 parts: screening, study treatment, and safety follow up.

A screening visit is conducted by a study coordinator or clinical research nurse to determine if you are eligible to participate in the clinical trial. This includes the informed consent process, medical history and physical examination, vital signs and measurements, laboratory tests, and any necessary additional assessments such as X-rays.
The study treatment will last for 52 weeks (1 year) with site visits occurring about every 4 weeks. At these visits, a study coordinator, clinical research nurse or physician will conduct assessments to determine your response to therapy.
Following the treatment period, there will be 1 follow-up visit to report any side effects or other safety information to the investigator.

There is a 2 in 3 chance of being placed in a patient group receiving zetomipzomib. All patients will be randomized into one of three groups to receive either a 30 mg dose of zetomipzomib, a 60 mg dose of zetomipzomib or placebo through a weekly injection under the skin. During the clinical trial, you will be able to continue taking any other medications that your physician has prescribed for treating your lupus nephritis.

The investigating physician, the hospital staff, and you will not know which treatment you receive. This “blinding” is meant to avoid bias in the clinical trial results.

SCREENING

UP TO 5 WEEKS

1 VISIT

STUDY TREATMENT

52 WEEKS

15-52 VISITS

FOLLOW-UP

4 WEEKS

1 VISIT

There is a 2 in 3 chance of being placed in a patient group receiving zetomipzomib. All patients will be randomized into one of three groups to receive either a 30 mg dose of zetomipzomib, a 60 mg dose of zetomipzomib or placebo through a weekly injection under the skin. During the clinical trial, you will be able to continue taking any other medications that your physician has prescribed for treating your lupus nephritis.

The investigating physician, the hospital staff, and you will not know which treatment you receive. This “blinding” is meant to avoid bias in the clinical trial results.

Who is Eligible?

To be eligible for the clinical trial:

Must be at least 18 years of age.
Have a kidney biopsy completed within the last year showing a clinical diagnosis of active lupus nephritis (Class III or IV, with or without Class V, or Class V alone). If you have not had a biopsy in the past year, you will need to complete a biopsy during the screening period for participation in the clinical trial.
Urine protein to creatinine ratio (UPCR) ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V).
Have a body mass index (BMI) of ≥18 kg/m².
Positive ANA test result and/or a positive anti-dsDNA serum antibody test.
Adequate hematologic, liver, and kidney function based on necessary lab results.
Must be willing to take steroids and mycophenolate mofetil or equivalent.

Clinical Trial Locations

The PALIZADE clinical trial is being conducted in the United States and globally in approximately 30 countries. If there is no site near you, please check back or visit clinicaltrials.gov for updates as new sites may become available.

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About Zetomipzomib

Zetomipzomib is a first-in-class, investigational product being studied for the treatment of lupus nephritis, a serious manifestation of lupus. Zetomipzomib acts by inhibiting the immunoproteasome, a structure found in immune cells that helps to regulate the normal functioning of the immune system.⁴

In autoimmune diseases such as lupus nephritis, the immune system that is meant to keep the body safe from pathogens instead attacks and causes damage to the kidneys and other healthy tissue.

Research has shown that blocking (inhibiting) the immunoproteasome may rebalance the activity of the overactive immune system, and this may have a beneficial therapeutic effect on lupus nephritis.

About Lupus Nephritis

Lupus nephritis, a serious manifestation of lupus, is a chronic autoimmune kidney disease. It occurs when the body’s immune system attacks the kidneys, causing inflammation and preventing the performance of vital functions.¹

Lupus nephritis places a significant burden on people with lupus, including fatigue, anxiety, and depression.
Lupus affects approximately 322,000 people in the United States, and approximately half will develop lupus nephritis at some point in their lives.⁵
African Americans, Hispanics, Latinos, and Asian Americans with lupus are at a higher risk for developing lupus nephritis.
Symptoms of lupus nephritis may include swelling of the feet, ankles, or hands and foamy urine caused by a high protein level, indicating kidney damage.¹
Lupus nephritis increases the risk of blood vessel problems, including high blood pressure, with an overall increase in the risk of death due to heart disease and infections that require hospitalization.⁶

Lupus nephritis may result in kidney failure that requires dialysis or a kidney transplant.⁷
In autoimmune diseases such as lupus nephritis, the immune system that is meant to keep the body safe from pathogens instead attacks and causes damage to the kidneys and other healthy tissue.
Current treatment approaches for lupus nephritis include long-term suppression (curbing) of the immune system with steroids and other drugs called immunosuppressants.⁸ These treatments can help manage lupus nephritis. Still, they don’t always work well enough and have significant side effects (e.g., infections).⁹

Participant Accommodations

We aim to make every participant’s PALIZADE clinical trial experience as easy as possible. Accommodations for trial participation vary by clinical trial location and may include the following:

Clinical trial assessments at no cost
Remote home trial services
Travel concierge

RESOURCES

Patient advocacy groups can offer additional educational resources and help you decide if a clinical trial is right for you. Check out these patient advocacy groups for more information and additional resources.

FAQs

About the PALIZADE clinical trial

Why is the PALIZADE clinical trial being conducted?

The PALIZADE clinical trial aims to learn more about zetomipzomib as a potential treatment for people living with lupus nephritis.

Who is conducting the PALIZADE clinical trial?

Kezar Life Sciences is sponsoring the PALIZADE clinical trial. Kezar is a biotechnology company discovering and developing potential new treatments for autoimmune disease and cancer. The company was founded in 2015 and is based in California. For more information, visit www.kezarlifesciences.com.

What ethical considerations are in place for the clinical trial?

Informed Consent: All participants will be provided informed consent before they can participate in the clinical trial. This means that they will be told about the risks and benefits of the clinical trial, and they must agree to participate voluntarily.
Confidentiality: All information collected from participants will be kept confidential. This means it cannot be shared with anyone outside the clinical trial team without the participant’s permission.
Protection from harm: All participants will be protected from harm. This means the clinical trial team will take steps to minimize the risks associated with the clinical trial.

What safety measures are in place for the clinical trial?

Some of the safety measures in place for clinical trials include:

Informed Consent: All participants in a clinical trial must provide informed consent before they can participate. This means that they must be given information about the clinical trial, including the risks and benefits, and they must agree to participate voluntarily.
Data safety monitoring: An independent data monitoring committee (IDMC) is a group of independent experts who review the data collected in a clinical trial on a regular basis. The IDMC is responsible for ensuring that the clinical trial is being conducted safely and that the participants are not being put at risk.
Adverse event reporting: All adverse events that occur in a clinical trial must be reported to the clinical trial team. An adverse event is any unwanted or unexpected medical occurrence that happens to a participant during a clinical trial.
Withdrawal from the clinical trial: Participants in a clinical trial have the right to withdraw at any time. If a participant withdraws from the clinical trial, they must be followed up with to ensure that they are not at risk of harm.

By taking these safety measures, researchers can help to ensure that clinical trials are conducted safely, and that the data collected is accurate and reliable.

Is there placebo in this clinical trial?

Yes. Since this is a randomized placebo-controlled clinical trial, some participants may receive placebo in addition to the current standard of care treatment. The purpose of placebo is to evaluate whether simply participating in a study affects study outcomes and to make sure the results of each group being studied are handled the same way. There is a 1/3 chance that a participant in the PALIZADE clinical trial receives placebo.

What is Kezar’s commitment to diversity in clinical trials?

Kezar-sponsored clinical trials aim to enroll representative numbers of participants from underrepresented racial and ethnic populations globally. Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population. Adequate representation of these populations in clinical trials helps ensure that the data generated in the development program reflects the racial and ethnic diversity of the population expected to use the medical product, if approved, and may potentially identify effects on safety and efficacy outcomes that may be associated with, or occur more frequently within these populations. Kezar Life Sciences is dedicated to having a patient-centric approach.

Will my personal information be kept private?

The clinical trial team will take steps to protect your privacy, including:

- Using pseudonyms or codes to identify you instead of your real name.
- Storing your data in a secure location where unauthorized individuals cannot access it.
- Requiring researchers to sign confidentiality agreements.

You will also have the right to withdraw from the study at any time. Data that was collected by your study doctor will still be able to be used by the sponsor.

How common is lupus nephritis?

As many as 5 out of 10 adults with lupus will develop lupus nephritis. Although lupus is 9x more common in women, men with lupus are more likely to develop lupus nephritis.

What causes lupus nephritis?

Immune cells that normally respond to foreign pathogens are overactive in lupus nephritis, attacking healthy kidney cells and causing inflammation that damages the kidneys.

Has zetomipzomib been studied before?

Yes, zetomipzomib was observed to be generally safe and tolerable in preclinical, phase 1, and phase 2 studies. Based on these clinical trials, Kezar is studying zetomipzomib in larger, placebo-controlled studies for autoimmune diseases, including lupus nephritis.

What is an immunoproteasome?

Immunoproteasomes are structures found in immune cells that are important in regulating the immune system. Research has shown that blocking or inhibiting the immunoproteasome may rebalance the activity of an overactive immune system.

About Clinical Trials

What is a clinical trial?

A clinical trial is conducted to evaluate the safety, effectiveness, and side effects of potential new treatments or interventions in humans. Clinical trials are typically conducted in phases, starting with small studies including a limited number of people and then progressively moving to larger controlled studies to determine if an investigational product is safe and effective in treating a medical condition. Clinical trials are essential for advancing medical knowledge and improving patient care.

What are the benefits of participating in a clinical trial?

Access to potential new treatments: Clinical trials offer the opportunity to receive access to new medical treatments or interventions that are not yet available to the general public.
Contributing to medical knowledge: Clinical trial participants can make a significant contribution to medical research by helping to advance our understanding of diseases and how to treat them.
Personal satisfaction: For some people, participating in a clinical trial can provide a sense of empowerment and a feeling of actively contributing to their own health and well-being, as well as to the health of others.

How do clinical trials work?

Video: See How Clinical Trials Work

What is an investigational product?

An investigational product is a drug or treatment that is being tested in clinical trials to determine whether it is safe and effective. Investigational products are potential treatments that are not yet approved for commercial use outside of clinical trials, and their safety and effectiveness have not yet been fully established.

Who oversees clinical trials?

Several entities oversee clinical trials to ensure that they are conducted ethically, safely, and with the highest possible scientific standards. Clinical trials are conducted with oversight from the United States Food & Drug Administration (FDA) and other regulatory agencies in other countries. Each hospital also maintains an ethics board to oversee the conduct of the clinical trial and the investigating physician, nurses, and healthcare professionals.

CONTACT US

For further information, please complete the form to the right or contact us at
+1-650-640-4480

¹https://www.mayoclinic.org/diseases-conditions/lupus-nephritis/symptoms-causes/syc-20354335 ²Tesar V, et al. Nephrol Clin Pract. 2014;128:205-21 ³Hoover PJ, et al. Kidney Int. 2016;90(3):487-492 ⁴Basler M, et al. Clin Exp Rheumatol. 2015;33(Suppl. 92):S74-S79 ⁵https://www.cdc.gov/lupus/basics/symptoms.htm ⁶Feldman CH, et al. Arthritis Rheumatol. 2015;67(6):1577-1585 ⁷Ortega LM, et al. Lupus. 2010;19(5):557–574 ⁸NIDDK. Lupus and kidney disease (lupus nephritis). Available at https://www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis. [Accessed March 24, 2023] ⁹Tesar V, et al. Nephrol Clin Pract. 2014;128:205-215.

Zetomipzomib (KZR-616) is an investigational product and has not been approved for commercial use in the United States or any other country for any indication.

Get Started

Join us in our mission to improve the lives of those with lupus nephritis.

Join us in our mission to improve the lives of those with lupus nephritis.

The PALIZADE Clinical Trial

WHAT to Expect: Step-by-Step Process

Who is Eligible?

Clinical Trial Locations

About Zetomipzomib

About Lupus Nephritis

Participant Accommodations

RESOURCES

FAQs

About the PALIZADE clinical trial

About Clinical Trials

CONTACT US

Contact Us