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Trial record 1 of 4 for:    KZR-616
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Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.

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ClinicalTrials.gov Identifier: NCT04628936
Recruitment Status : Enrolling by invitation
First Posted : November 16, 2020
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Kezar Life Sciences, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Polymyositis Dermatomyositis Drug: KZR-616 Phase 2

Detailed 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 SC injection of 30 mg KZR-616 at Visit 1 (Day 1), followed by weekly SC injections of 45 mg KZR-616 through Week 48 (EOT Visit). The final follow-up visit will occur 12 weeks following the last dose of KZR-616 (End of Study [EOS] Visit), for a total length of participation of up to approximately 60 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 through Week 48 (EOT Visit).
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 4, 2020
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : April 15, 2023


Arm Intervention/treatment
Experimental: KZR-616 45 mg + standard therapy (open-label)
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 through Week 48 (EOT Visit).
Drug: KZR-616
KZR-616 subcutaneous injection
Other Name: KZR-616 Lyophile




Primary Outcome Measures :
  1. Total Improvement Score (TIS) [ Time Frame: 80 weeks ]
    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.


Secondary Outcome Measures :
  1. International Myositis Assessment and Clinical Studies Group (IMACS) Definition of Improvement (DOI) [ Time Frame: 80 weeks ]
    Proportion of patients meeting IMACS definition of improvement (DOI) over time for patients with baseline core set measures.

  2. International Myositis Assessment and Clinical Studies Group (IMACS) individual Core Set Activity Measures (CSAMs) [ Time Frame: 80 weeks ]
    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.

  3. Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) [ Time Frame: 60 weeks ]
    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.

  4. Corticosteroid and non-corticosteroid immunosuppressants [ Time Frame: 60 weeks ]
    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.


Other Outcome Measures:
  1. Peak Pruritus Numeric Rating Scale Pruritis Numerical Rating Scale [NRS] [ Time Frame: 60 weeks ]
    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.

  2. 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). [ Time Frame: 60 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628936


Locations
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United States, California
KZR Research Site
Irvine, California, United States, 92698
United States, Kansas
KZR Research Site
Kansas City, Kansas, United States, 66160
United States, Michigan
KZR Research Site
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
KZR Research Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
KZR Research Site
Austin, Texas, United States, 78756
Sponsors and Collaborators
Kezar Life Sciences, Inc.
Investigators
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Study Director: Kezar Study Director Kezar Life Sciences, Inc.
Additional Information:
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Responsible Party: Kezar Life Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04628936    
Other Study ID Numbers: KZR-616-003E
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kezar Life Sciences, Inc.:
Myositis
Idiopathic inflammatory myopathies
Polymyositis
Dermatomyositis
Musculoskeletal Diseases
Muscular Diseases
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases