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

Dermatomyositis Clinical Trial

Official title:

An Open-label Extension to the 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628936
• Other study ID #: KZR-616-003E
• Status: Completed
• Phase: Phase 2
• Start date: November 4, 2020
• Est. completion date: June 12, 2023

Study information

• Verified date: May 2024
• Source: Kezar Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis or dermatomyositis who completed the double-blind treatment period of Study KZR-616-003 (NCT04033926), up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.

Patients were evaluated for eligibility according to the entry criteria at, or within 8 weeks after, the Week 32 Visit (ie, the End of Treatment [EOT] Visit [Visit 34]) of Study KZR-616-003.

All patients received a subcutaneous (SC) injection of 30 mg KZR-616 at Visit 1 (Day 1), followed by weekly SC injections of 45 mg KZR-616 up to a maximum of 96 weeks. Study drug administration ended for all patients in Study KZR-616-003E when the last patient enrolled completed 48 weeks of dosing. Patients had a final follow-up visit 12 weeks after their last dose of KZR-616 (End of Study [EOS] Visit), for a maximum potential length of participation of 108 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 12, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dermatomyositis
• Polymyositis

Intervention

Drug:
• KZR-616
Subcutaneous 30 mg for 1 week, then 45 mg weekly

Locations

Country	Name	City	State
Czechia	KZR Research Site	Prague
United States	KZR Research Site	Ann Arbor	Michigan
United States	KZR Research Site	Austin	Texas
United States	KZR Research Site	Baltimore	Maryland
United States	KZR Research Site	Beverly Hills	California
United States	KZR Research Site	Duncansville	Pennsylvania
United States	KZR Research Site	Kansas City	Kansas
United States	KZR Research Site	Miami	Florida
United States	KZR Research Site	Orange	California
United States	KZR Research Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Kezar Life Sciences, Inc.

Countries where clinical trial is conducted

United States,  Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Total Improvement Score (TIS) at OLE Week 48	The mean Total Improvement Score (TIS) at OLE Week 48, which ranges from 0 to 100 [low of 0 to high of 100, where higher scores are better]. The timeframe of 48 weeks was selected because it represented the maximum timeframe of dosing for the last patient enrolled as the study drug administration ended when the last patient enrolled completed 48 weeks of dosing.	48 weeks

External Links

•   Kezar Life Sciences, Inc. corporate website