A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients with Polymyositis or Dermatomyositis


Kezar Life Sciences, Inc is evaluating an investigational drug in a clinical research study to determine whether it can help improve the symptoms of polymyositis (PM) or dermatomyositis (DM).

We are currently looking for eligible participants that have been diagnosed by a physician with PM or DM and currently have active disease with muscle weakness to be enrolled into the Phase 2 PRESIDIO study at multiple clinical trial sites in the United States.

All participants in the study will receive the investigational drug, KZR-616, or a placebo (an inactive treatment) given once weekly through an injection (a shot) at the clinic or in their home by a certified nurse for a period of 16 weeks. All participants will then cross-over to receive KZR-616 (if originally receiving placebo) or placebo (if originally receiving KZR-616) for an additional treatment period of 16 weeks. There will be a follow up period requiring monthly visits to the study site for an additional 8 weeks.

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

The aim of the current study is to investigate whether treatment with KZR-616 can help improve the symptoms of PM and DM.

About Polymyositis (PM)

Polymyositis is an autoimmune disorder that causes inflammation of the muscles.  People with PM may present with muscle weakness in the arms and legs, shortness of breath, difficulty swallowing, fatigue, muscle tenderness or pain, fever, and weight loss. Treatment for PM is usually with drugs that affect the immune response, such as corticosteroids or immunosuppressants.

About Dermatomyositis (DM)

Dermatomyositis is an autoimmune disorder that causes inflammation of the muscle and the skin. People with DM may present with the symptoms of PM and with skin rash, as well as swelling around the eyes and fingernails. DM may be treated with corticosteroids or immunosuppressants.

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 disease like PM and DM. 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 either visit the study site or have a home nurse visit once a week during the 32-week treatment period and will need to visit the study site once a month during the 8-week follow up period.

Who is Eligible for this Study?

To be considered eligible for the PRESIDIO study, participants must:

  • Be at least 18 years of age
  • Have been diagnosed by a physician with polymyositis or dermatomyositis and currently have active disease with muscle weakness
  • Have found that treatments like corticosteroids or immunosuppressants do not work well or cannot be taken due to side effects
Participants must meet other study criteria to take part in the PRESIDIO 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 PRESIDIO

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