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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05781750
Ethics application status
Date submitted
12/03/2023
Date registered
23/03/2023

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
Stopped early
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
Actual
8/11/2024
Sample size
Target
Accrual to date
Final
84
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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Leicester
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05781750