MedTrace Logo

Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.

NCT04628936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-11-19

Study results available
· View outcomes & findings →

Summary

This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.

Conditions

  • Polymyositis
  • Dermatomyositis

Interventions

DRUG

KZR-616

Subcutaneous 30 mg for 1 week, then 45 mg weekly

Sponsors & Collaborators

  • Kezar Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Kezar Study Director · Kezar Life Sciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2023-03-10
Completion
2023-06-12
FDA Drug
Yes

Countries

  • United States
  • Czechia

Study Locations

More Related Trials

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 NCT04628936 on ClinicalTrials.gov