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: July 2023
• Source: Kezar Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active PM or 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 is 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, up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616. Patients will be 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 will receive 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 will end for all patients in Study KZR-616-003E when the last patient enrolled has completed 48 weeks of dose. Patients will have 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:

• Have clinical evidence of significant unstable or uncontrolled diseases other than the disease under study, that in the opinion of the Investigator or Sponsor/designee, could confound the results of the study, put the patient at undue risk, or interfere with protocol adherence.
• 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
KZR-616 subcutaneous injection

Locations

Country	Name	City	State
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	Irvine	California
United States	KZR Research Site	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kezar Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peak Pruritus Numeric Rating Scale Pruritis Numerical Rating Scale [NRS]	For DM patients, the Peak Pruritus Numeric Rating Scale ranges from a score of 0 to 10, with 0 representing no itch and 10 representing the worst itch imaginable during the worst moment within a 24-hour recall period.	60 weeks
Other	Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) with the causal relationship assessed by the investigator graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).	Safety	60 weeks
Primary	Total Improvement Score (TIS)	Mean change in TIS over time for all patients, for patients with DM only, for patients with PM only, and for patients with a myositis-associated antibody or myositis-specific antibody.	80 weeks
Secondary	Total Improvement Score (TIS) response	Proportion of patients by TIS response (minimal response = TIS = 20, moderate response; = TIS = 40, major response = TIS = 60)	80 weeks
Secondary	International Myositis Assessment and Clinical Studies Group (IMACS) Definition of Improvement (DOI)	Proportion of patients meeting IMACS definition of improvement (DOI) over time for patients with baseline core set measures.	80 weeks
Secondary	International Myositis Assessment and Clinical Studies Group (IMACS) individual Core Set Activity Measures (CSAMs)	Mean change and mean percentage change over time in the IMACS individual CSAMs and CSDMs, stratified by all patients and patients with myositis-associated or myositis-specific antibody.	80 weeks
Secondary	Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)	Mean change over time in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) for all patients with DM, and for patients with DM who have active skin manifestations at baseline of Study KZR-616-003E.	60 weeks
Secondary	Corticosteroid and non-corticosteroid immunosuppressants	Change in proportion and dose of corticosteroid and non-corticosteroid immunosuppressants during Study KZR-616-003E for all patients, and for patients taking corticosteroids or non-corticosteroid immunosuppressants at baseline of Study KZR-616-003E.	60 weeks

External Links

•   Kezar Life Sciences, Inc. corporate website