A Phase 1b/2 Clinical Study of KZR-616 for the Treatment of Lupus and 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 lupus nephritis to be enrolled into the Phase 2 portion of the study at multiple clinical trial sites in the United States.  

All participants in the study will receive background therapy of corticosteroids and CellCept® (mycophenolate mofetil or MMF), Myfortic® (mycopheolic acid or MPA), or Cytoxan® (cyclophosphamide), with either the investigational drug, KZR-616, or placebo (an inactive treatment), given once weekly through an injection (shot) at the clinic or in their home by a certified nurse for a period of six months. All participants may then choose to start (if originally receiving placebo) or continue treatment with KZR-616 for an additional six months

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 given with background therapy of low doses of corticosteroids (steroids) and CellCept® (mycophenolate mofetil or MMF), Myfortic® (mycophenolic acid or MPA), or Cytoxan® (cyclophosphamide) will be able to reduce disease activity in people with biopsy confirmed LN. People who have proteinuria (spilling of protein in the urine) and have had a kidney biopsy showing evidence of LN with proteinuria may be eligible to enter the study. If you have not had a kidney biopsy within 12 months, you may receive a kidney biopsy at no cost to you to become 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 can 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 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 biopsy
    (or willing to have confirmed by biopsy)
  • Have proteinuria (protein spilling into the urine)
  • Are on or willing to go on stable doses of corticosteroids (steroids)
    and CellCept® (mycophenolate mofetil or MMF), Myfortic®
    (mycophenolic acid or MPA), or Cytoxan ® (cyclophosphamide)
Participants 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.

Study Locations

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

Request information about MISSION

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