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

COMPLETEDPHASE2

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

NCT04033926•Kezar Life Sciences, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult patients at least 18 years of age
•2. Body Mass Index (BMI) of 18 to 40 kg/m\^2
•3. Diagnosis of probable or definite DM or PM by the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria
•4. Must have their data reviewed by an adjudication committee to confirm eligibility unless at least 1 of the following is present:
•1. Muscle biopsy with evidence of active myositis within the last 6 months prior to or at Screening
•2. Electromyography or magnetic resonance imaging with evidence of active myositis within the last 6 months prior to Screening
•3. A creatine kinase (CK) ≥4 × upper limit of normal (ULN).
•5. Must have demonstrable muscle weakness as measured by the Manual Muscle Testing-8 muscle Groups (MMT-8) with a score ≥80/150 but ≤136/150 units and any 2 of the following:
•1. Physician Global Assessment (MDGA) visual analog scale (VAS) ≥2 cm
•2. Patient Global Assessment of Disease Activity (PtGADA) VAS ≥2 cm
+4 more criteria

Exclusion Criteria

•1. Has significant muscle damage or has a muscle damage VAS score ≥5 cm on the MDI
•2. Any other form of myositis or myopathy other than PM or DM
•3. Any condition that precludes the ability to quantitate muscle strength
•4. Has severe interstitial lung disease or has a pulmonary damage VAS score ≥5 cm on the Myositis Damage Index (MDI)
•5. Presence of autoinflammatory disease
•6. Use of nonpermitted medications or treatments within the specified washout periods prior to screening
•7. Patient has had recent serious or ongoing infection, or risk for serious infection
•8. Any of the following laboratory values at Screening:
•1. Estimated glomerular filtration rate \<45 mL/min
•2. Hemoglobin \<10 g/dL
+12 more criteria

Locations (14)

KZR Research Site

Beverly Hills, California, United States

KZR Research Site

Orange, California, United States

KZR Research Site

Miami, Florida, United States

KZR Research Site

Atlanta, Georgia, United States

KZR Research Site

Kansas City, Kansas, United States

KZR Research Site

Baltimore, Maryland, United States

KZR Research Site

Ann Arbor, Michigan, United States

KZR Research Site

Great Neck, New York, United States

KZR Research Site

Duncansville, Pennsylvania, United States

KZR Research Site

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

January 14, 2020

Primary Completion Date

April 6, 2022

Completion Date

April 6, 2022

Last Updated

November 19, 2025

Enrollment

ACTUAL participants

Conditions

PolymyositisDermatomyositis

Interventions

KZR-616

DRUG

Placebo

DRUG

Rheumatology Patient Registry and Biorepository

NCT04402086

Rheumatic DiseasesAdult Onset Still Disease+18 more

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RECRUITINGPHASE2/PHASE3

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NCT07160205

Idiopathic Inflammatory Myositis (IIM)DERMATOMYOSITIS OR POLYMYOSITIS

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Rheumatology Patient Registry and Biorepository

Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)

MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)

Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)