Autoimmune Disorders Polymyositis and Dermatomyositis MedDRA version: 20.0 Level: HLGT Classification code 10003816 Term: Autoimmune disorders System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: KZR-616
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: KZR-616
Current Sponsor code: KZR
Other descriptive name: KZR-616 maleate
Concentration unit: mg
Sponsors
Kezar Life Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must have successfully completed Study KZR-616-003 through Week 32, including the Week 32 Visit assessments, be willing and able to provide written informed consent prior to any study-related procedures, and be willing and able to comply with study requirements. 2. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test prior to the first dose of KZR-616 in Study KZR-616-003E, and must agree to continue to use a highly effective method of birth control until completion of the study (or 30 days following the last dose of KZR-616 in case of early withdrawal). Women of childbearing potential are defined as postpubescent female patients, unless the patient is postmenopausal (defined by amenorrhea for at least 2 years or amenorrhea for at least 1 year with confirmatory follicle stimulating hormone [FSH] level in the postmenopausal range, as documented historically or measured by the central or local laboratory and if patient is not on supplementary hormonal therapy) or surgically sterile (ie, tubal ligation, hysterectomy, bilateral salpingoophorectomy). 3. Male patients must continue to use an effective contraception method (eg, condom with spermicide) for 1 week following their last dose of KZR-616 or be congenitally or surgically sterile (eg, vasectomy with documented confirmation of post-surgical aspermia). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Have clinical evidence of significant unstable or uncontrolled diseases other than the disease under study (eg, cardiac [including congestive heart failure, hypertension, angina, or myocardial infarction], pulmonary [including pulmonary hypertension or interstitial lung disease], hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurological, or infectious disease, any ongoing SAE(s), or AE(s) = Grade 3 by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]) 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. 2. 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. 3. 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 (ICF). 4. Have hypersensitivity to KZR-616 or any of its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Efficacy Endpoints: • 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 at the Screening Visit of Study KZR-616-003 • Proportion of patients meeting International Myositis Assessment and Clinical Studies Group (IMACS) definition of improvement (DOI) over time for patients with baseline core set measures as ascertained at the beginning of KZR-616-003 • Mean change and mean percentage change over time in the IMACS individual core set activity measures (CSAMs) and core set damage measures (CSDMs), stratified by all patients and patients with myositis-associated or myositis-specific antibody at the Screening Visit of Study KZR-616-003 • 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 • Mean change over time in the Myositis Damage Index (MDI) • Mean change over time in muscle enzymes • 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 • Percentage of patients requiring additional medication for myositis treatment during Study KZR-616-003E • Mean change over time in the EuroQol 5-dimension 5-level (EQ-5D-5L) • Additional exploratory endpoints (Physician Global Impression of Change [MDGIC], Functional Index-2 [FI-2], Patient Global Impression of Change [PGIC], and Peak Pruritis Numerical Rating Scale [NRS]) will be assessed at multiple time points Safety Endpoints: • Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) • Incidence of AEs leading to KZR-616 discontinuation • Changes in standard laboratory parameters and | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): no secondary end points;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Czechia, Czech Republic
Contacts
Public ContactKezar Life Sciences, Inc.
Kezar Life Sciences, Inc.
Outcome results
None listed