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

  • STATUS
    Recruiting
  • End date
    Apr 25, 2022
  • participants needed
    24
  • sponsor
    Kezar Life Sciences, Inc.
Updated on 29 August 2021
cancer
MRI
weakness
body mass index (bmi)
muscle biopsy
creatine kinase
dermatomyositis
polymyositis
muscle enzyme
mdga

Summary

"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.

Details
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

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note