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

Completed · Phase 2

Conditions studied: Polymyositis, Dermatomyositis

In brief

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.

Key facts

Study ID

NCT04628936

Run by

Kezar Life Sciences, Inc.

People needed

18

Starts

2020-11-04

Expected to finish

2023-06-12

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have successfully completed Study KZR-616-003 through Week 32, including the Week 32 Visit assessments
• Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test prior to the first dose of KZR-616 in KZR-616-003E, and must agree to continue to use a highly effective method of birth control until completion of the study.
• Male patients must continue to use an effective contraception method for 1 week following their last dose of KZR-616 or be congenitally or surgically sterile.

You may not qualify if…

• Has participated in any clinical study other than KZR-616-003 between the Week 32 Visit of Study KZR-616-003 and the first study visit of KZR-616-003E, if they are not on the same calendar day.
• Are females who are breastfeeding or who plan to become pregnant during the study, or who are actively trying to conceive at the time of signing of the informed consent form.
• Have hypersensitivity to KZR-616 or any of its excipients.

Where it is running

• 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 — Kansas City, Kansas, United States
• KZR Research Site — Baltimore, Maryland, United States
• KZR Research Site — Ann Arbor, Michigan, United States
• KZR Research Site — Duncansville, Pennsylvania, United States
• KZR Research Site — Pittsburgh, Pennsylvania, United States
• KZR Research Site — Austin, Texas, United States
• KZR Research Site — Prague, Czechia

Full record on ClinicalTrials.gov

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