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Monoclonal Antibodies

Arm A for Dermatomyositis (PRESIDIO Trial)

Phase 2
Waitlist Available
Research Sponsored by Kezar Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks in each treatment period (32 weeks total)
Awards & highlights

PRESIDIO Trial Summary

This trial 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).

Eligible Conditions
  • Dermatomyositis
  • Polymyositis

PRESIDIO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks in each treatment period (32 weeks total)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks in each treatment period (32 weeks total) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period
Secondary outcome measures
Absolute change from start to end of KZR-616 treatment in the IMACS individual core set activity measures (CSAMs)
Area under the plasma concentration versus time curve (AUC) following KZR-616 injection
For patients with DM, the mean change from start to end of KZR-616 treatment in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
+8 more

PRESIDIO Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment2 Interventions
Treatment Period 1: Placebo SC weekly for 16 weeks Treatment Period 2: KZR-616 30 mg SC weekly for 2 weeks, then 45 mg SC weekly for 14 weeks
Group II: Arm AExperimental Treatment2 Interventions
Treatment Period 1: KZR-616 30 mg SC weekly for 2 weeks, then 45 mg SC weekly for 14 weeks Treatment Period 2: Placebo SC weekly for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KZR-616
2018
Completed Phase 2
~120
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Kezar Life Sciences, Inc.Lead Sponsor
6 Previous Clinical Trials
615 Total Patients Enrolled
1 Trials studying Dermatomyositis
18 Patients Enrolled for Dermatomyositis
KezarStudy DirectorKezar Life Sciences, Inc.
2 Previous Clinical Trials
69 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
2020. "A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04033926.
~5 spots leftby Apr 2025
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