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 (EudraCT Number: 2019-002605-22), up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.
- Conditions
- Autoimmune Disorders Polymyositis and DermatomyositisMedDRA version: 20.0Level: HLGTClassification code 10003816Term: Autoimmune disordersSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-004382-39-CZ
- Lead Sponsor
- Kezar Life Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 24
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method