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

NCT04033926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-11-19

Study results available
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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

DRUG

KZR-616

Subcutaneous 30 mg weekly for 2 weeks, then 45 mg weekly for 14 weeks

DRUG

Placebo

Subcutaneous injection for 16 weeks

Sponsors & Collaborators

  • Kezar Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Kezar · Kezar Life Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2022-04-06
Completion
2022-04-06
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033926 on ClinicalTrials.gov