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

  • End date
    Apr 25, 2022
  • participants needed
  • sponsor
    Kezar Life Sciences, Inc.
Updated on 29 August 2021
body mass index (bmi)
muscle biopsy
creatine kinase
muscle enzyme


"This is a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of treatment with KZR-616 in patients with active Polymyositis (PM) or Dermatomyositis (DM). Patients will be evaluated for eligibility during the Screening Period. Eligible patients will be randomized 1:1 to Arm A or Arm B of the study.

During the 32-week treatment period, patients will receive study drug subcutaneously (SC) once weekly with 2 treatment periods of 16 weeks each.

This study will be conducted on an outpatient basis.

Condition Dermatomyositis, CONNECTIVE TISSUE DISEASE, Myositis, Dermatosis, Polymyositis, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Polymyositis (Inflammatory Muscle Disease), Skin Conditions, Connective Tissue Diseases, Idiopathic Inflammatory Myopathies
Treatment Placebo, KZR-616
Clinical Study IdentifierNCT04033926
SponsorKezar Life Sciences, Inc.
Last Modified on29 August 2021

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