MISSION Study: A Clinical Study Evaluating a Potential New Treatment For Lupus Nephritis
A Phase 2 Study of KZR-616 for the Treatment of Lupus Nephritis
Kezar Life Sciences, Inc.
Purpose of Study:
Kezar Life Sciences is evaluating the efficacy, safety, and tolerability of an investigational medication, KZR-616, in a clinical study (MISSION) in adult patients with active lupus nephritis (LN) across multiple clinical trial sites in the United States. KZR-616 is a first-in-class selective immunoproteasome inhibitor with broad therapeutic potential for those living with autoimmune diseases.
What Does this Study Involve?:
- Study participants will receive KZR-616 once weekly through injection at the clinic or in their home by a certified nurse for a period of 24 weeks
- After the 24-week initial treatment period, participants will have the option to be part of a follow-up period requiring monthly visits to the clinic for an additional 12 weeks or enroll in an extension study to continue KZR-616
- All study assessments, investigational drug, and procedures will be provided at no cost to participants
You May Qualify for This Study If You:
- Are between the ages of 18 and 75 years of age
- Have lupus nephritis that has been confirmed by kidney biopsy (or willing to have confirmation by biopsy)
- Have proteinuria (protein in the urine)
- Are currently on standard therapy for lupus nephritis of at least one immunosuppressant (mycophenolate mofetil, mycophenolic acid, azathioprine, tacrolimus, leflunomide, cyclosporin, methotrexate)
You May Not Be Able to Participate In the Study, If You Have:
- Presence of another rheumatic (overlap) disease that may confound clinical assessments in the study
- Recent serious or ongoing infection, or risk for serious infection, including:
- Known seropositivity for or active infection with HIV (positive screening test and negative confirmatory test are eligible)
- Active Hepatitis B or Hepatitis C infection
- Active or untreated latent TB
- Interventional (Clinical Trial)
- Phase 2
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. Any questions, contact firstname.lastname@example.org.
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