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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KZR-616 45 mg + standard therapy (open-label) | Experimental | All patients received a 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KZR-616 | Drug | Subcutaneous 30 mg for 1 week, then 45 mg weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kezar Study Director | Kezar Life Sciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KZR Research Site | Beverly Hills | California | 90211 | United States | ||
| KZR Research Site |
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| Label | URL |
|---|---|
| Kezar Life Sciences, Inc. corporate website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | KZR-616 45 mg + Standard Therapy (Open-label) | All patients received SC injections of KZR-616 once weekly (QW) at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616. KZR-616: zetomipzomib subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2021 |
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All patients received a 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 when the last patient enrolled completed 48 weeks of dosing.
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| Orange |
| California |
| 92868 |
| United States |
| KZR Research Site | Miami | Florida | 33136 | United States |
| KZR Research Site | Kansas City | Kansas | 66160 | United States |
| KZR Research Site | Baltimore | Maryland | 21224 | United States |
| KZR Research Site | Ann Arbor | Michigan | 48109 | United States |
| KZR Research Site | Duncansville | Pennsylvania | 16635 | United States |
| KZR Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| KZR Research Site | Austin | Texas | 78756 | United States |
| KZR Research Site | Prague | Czechia |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KZR-616 45 mg + Standard Therapy (Open-label) | All patients received SC injections of KZR-616 QW at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616. KZR-616: zetomipzomib subcutaneous injection |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Nine (9) patients were enrolled in the OLE study at Week 48. | Posted | Mean | Standard Deviation | score on a scale | 48 weeks |
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Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KZR-616 45 mg + Standard Therapy (Open-label) | All patients received SC injections of KZR-616 QW at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616. KZR-616: zetomipzomib subcutaneous injection | 0 | 18 | 1 | 18 | 17 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wellens' syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Diastolic dysfunction | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Dry eye | Eye disorders | Systematic Assessment |
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| Keratitis | Eye disorders | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Infusion site reaction | General disorders | Systematic Assessment |
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| Injection site bruising | General disorders | Systematic Assessment |
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| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site exfoliation | General disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment |
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| Injection site inflammation | General disorders | Systematic Assessment |
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| Injection site irritation | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Injection site pruritus | General disorders | Systematic Assessment |
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| Injection site rash | General disorders | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Injection site urticaria | General disorders | Systematic Assessment |
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| Injection site vesicles | General disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Vaccination site pain | General disorders | Systematic Assessment |
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| Biliary dilatation | Hepatobiliary disorders | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | Systematic Assessment |
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| Adenovirus infection | Infections and infestations | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
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| Administration related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Injection related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post vaccination syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
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| Underdose | Injury, poisoning and procedural complications | Systematic Assessment |
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| Reticulocyte count increased | Investigations | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| Abnormal weight gain | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Menopausal symptoms | Reproductive system and breast disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatomyositis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hot flush | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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PI shall have the right to publish or present their own data resulting from the Study ("Publication") upon the earlier of: (a) the date following a multicenter publication coordinated by Sponsor regarding the Protocol; (b) 12 months after completion of the Protocol by all sites; or (c) the date after submission of the Study Data by Sponsor to the FDA.
The PI must furnish Sponsor with a copy of any Publication at least 30 days in advance of the proposed submission or presentation date.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Affairs | Kezar Life Sciences, Inc | 650-822-5600 | clinicaltrials@kezarbio.com |
| May 8, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D003882 | Dermatomyositis |
| D009220 | Myositis |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000712054 | KZR-616 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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