A Phase 2 Clinical Study of KZR-616 for the Treatment of Lupus Nephritis

About MISSION

Kezar Life Sciences is evaluating an investigational medication in a clinical research study to determine whether it can help people living with lupus nephritis (LN).

We are currently looking for participants with LN to be enrolled into the Phase 2 study at multiple clinical study sites in the United States.

All participants in the study will receive the investigational drug, KZR-616, added to their standard therapy of at least one immunosuppressant (mycophenolate mofetil, azathioprine, methotrexate, leflunomide, cyclosporin, tacrolimus, others) given once weekly through an injection (shot) at the clinic or in their home by a certified nurse for a period of six months. Participants may then choose to continue treatment with KZR-616.

All study assessments, investigational study drug, and procedures will be provided at no cost to participants.

The aim of the current study is to investigate whether KZR-616, when added to standard therapy that patients take for LN reduces disease activity in people with biopsy confirmed LN. People who have proteinuria (spilling of protein into the urine) and have had a kidney biopsy showing evidence of LN may be eligible to enter the study. If you have not had a kidney biopsy within 2 years, you may still be eligible to participate.

About Lupus Nephritis (LN)

LN is an inflammation of the kidneys that is caused by systemic lupus erythematosus (SLE). Approximately 50% of people living with SLE will develop lupus nephritis during their disease. While treatments exist for LN, there are currently no FDA-approved therapies specifically for the treatment of LN. Like SLE, LN is also a chronic disease that can be severely debilitating and lead to an increased risk of serious complications.

About KZR-616

KZR-616, which is the investigational drug in this study, is a selective immunoproteasome inhibitor. The immunoproteasome is found inside cells of the immune system and is responsible for breaking down various proteins in these cells. By blocking protein breakdown, laboratory research has indicated that KZR-616 may reduce the inflammation and autoimmune processes that underly diseases like LN. We believe that KZR-616 may have broad therapeutic potential across multiple autoimmune diseases, while having the potential to avoid immunosuppression.

What to expect during Study Visits

Eligible participants will need to visit the study site once a week or have a certified nurse visit you at home during the treatment period.

Who is Eligible for this Study?

To be considered eligible for the MISSION study participants must:

  • Be between the ages of 18 and 75 years of age
  • Have lupus nephritis that has been confirmed by kidney biopsy within the last 2 years
  • Have proteinuria (protein spilling into the urine)
  • Are on standard therapy of at least one immunosuppressant, including but not limited to mycophenolate mofetil, azathioprine, methotrexate, leflunomide, cyclosporin, tacrolimus with or without steroids and/or an anti-malarial (hydroxychloroquine, chloroquine)
Patients must meet other study criteria to take part in the MISSION Study.

For more information, please contact clinicaltrials@kezarbio.com or see the full list of eligibility criteria at ClinicalTrials.gov.
Disclaimer:
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

Study Locations

Additional sites to be opened, please check back for updates.

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