NCT04033926

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

A Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or Dermatomyositis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Kezar Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was 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 were evaluated for eligibility during the Screening Period. Eligible patients were stratified by diagnosis of DM or PM and randomized 1:1 to Arm A or Arm B of the study. During the 32-week treatment period, patients received study drug subcutaneously (SC) once weekly with 2 treatment periods of 16 weeks each. This study was conducted on an outpatient basis.

Conditions

• Polymyositis
• Dermatomyositis

Interventions

Type	Name	Description
DRUG	KZR-616	Subcutaneous 30 mg weekly for 2 weeks, then 45 mg weekly for 14 weeks
DRUG	Placebo	Subcutaneous injection for 16 weeks

Timeline

• Start date: 2020-01-14
• Primary completion: 2022-04-06
• Completion: 2022-04-06
• First posted: 2019-07-26
• Last updated: 2025-11-19
• Results posted: 2024-01-03

Locations

14 sites across 3 countries: United States, Czechia, Germany

Regulatory

• FDA-regulated drug study