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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05781750




Registration number
NCT05781750
Ethics application status
Date submitted
12/03/2023
Date registered
23/03/2023
Date last updated
16/05/2024

Titles & IDs
Public title
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
Scientific title
A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg With Placebo in Patients With Active Lupus Nephritis
Secondary ID [1] 0 0
KZR-616-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - zetomipzomib
Treatment: Drugs - placebo

Experimental: zetomipzomib 30 mg + standard-of-care - Initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through 52 weeks of the treatment period.

Experimental: zetomipzomib 60 mg + standard-of-care - Initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through 52 weeks of the treatment period.

Placebo Comparator: placebo + standard-of-care - Initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through 52 weeks of the treatment period.


Treatment: Drugs: zetomipzomib
Subcutaneous injection of zetomipzomib

Treatment: Drugs: placebo
Subcutaneous injection of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the efficacy of zetomipzomib
Timepoint [1] 0 0
Baseline through Week 37
Primary outcome [2] 0 0
To evaluate safety of zetomipzomib
Timepoint [2] 0 0
Baseline through Week 56
Secondary outcome [1] 0 0
Partial Renal Remission (PRR)
Timepoint [1] 0 0
Baseline through Week 25, Week 37, and Week 53
Secondary outcome [2] 0 0
CRR
Timepoint [2] 0 0
Baseline through Week 25 and Week 53

Eligibility
Key inclusion criteria
Key

- Body mass index of =18 kg/m^2

- eGFR =30 mL/min/1.73 m^2

- Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody
test

- Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal
biopsy performed within 12 months prior to Screening.

- UPCR =1.0 (Class III/IV +/-V) or UPCR =2.0 (Class V)

- Adequate hematologic, hepatic, and renal function

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current or medical history of:

- Central nervous system manifestations of SLE

- Overlapping autoimmune condition that may affect study assessments/outcomes

- Antiphospholipid syndrome with history of thromboembolic event of within the 52
weeks prior to Screening

- Thrombocytopenia or at high risk for developing clinically significant bleeding
or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or
platelet transfusions

- Solid organ transplant or planned transplant during study

- Malignancy of any type, with exceptions for non-melanoma skin cancers and certain
cancers >5 years ago

- Has received dialysis within the 52 weeks prior to Screening

- Positive test at Screening for HIV, hepatitis B/C

- Known intolerance to MMF or equivalent and corticosteroids

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
279
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Gold Coast Hospital and Health Service - Southport
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
3021 - St Albans
Recruitment outside Australia
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Santa Fe
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Pilar
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kezar Life Sciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60
mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients
with active lupus nephritis (LN).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05781750
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven Kimmel, MD
Address 0 0
West Broward Rheumatology Associates, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kezar Life Sciences, Inc
Address 0 0
Country 0 0
Phone 0 0
(650) 640-4480
Fax 0 0
Email 0 0
PALIZADE@kezarbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05781750