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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06064929




Registration number
NCT06064929
Ethics application status
Date submitted
26/09/2023
Date registered
3/10/2023

Titles & IDs
Public title
A Study of Felzartamab in Participants With Lupus Nephritis
Scientific title
An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis
Secondary ID [1] 0 0
HIB-202-101
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 - Felzartamab

Experimental: Felzartamab -


Treatment: Drugs: Felzartamab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)
Timepoint [1] 0 0
Baseline, Up to 12 months
Secondary outcome [2] 0 0
Proportion of Participants Who Achieve a Complete Renal Response (CRR)
Timepoint [2] 0 0
Month 6
Secondary outcome [3] 0 0
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (CRR+PRR)
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
Change from Baseline in Serum Creatinine
Timepoint [4] 0 0
Baseline, Up to 12 months
Secondary outcome [5] 0 0
Change from Baseline in Urine Protein
Timepoint [5] 0 0
Baseline, Up to 12 months
Secondary outcome [6] 0 0
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [6] 0 0
Baseline, Up to 12 months
Secondary outcome [7] 0 0
Change from Baseline in eGFR Slope
Timepoint [7] 0 0
Baseline, Up to 12 months
Secondary outcome [8] 0 0
Change from Baseline in Lupus Serologic Markers
Timepoint [8] 0 0
Baseline, Up to 12 months
Secondary outcome [9] 0 0
Felzartamab Serum Concentrations
Timepoint [9] 0 0
Up to 12 months
Secondary outcome [10] 0 0
Number of Participants with Anti-drug Antibodies to Felzartamab
Timepoint [10] 0 0
Baseline, Up to 12 months

Eligibility
Key inclusion criteria
* Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria
* Diagnosis of International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 1 year prior to or during screening, either with or without the presence of Class V LN
* Proteinuria (urine protein to creatinine ratio) > 1.0 gram per gram (g/g), based on 24-hour urine collection during screening
* eGFR = 45 milliliter/minute/1.73 square meters (mL/min/1.73 m^2) (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula)
* History of inadequate response, for lack of efficacy or intolerance, to at least a three-month course of one standard of care treatment for lupus nephritis, as determined by the treating physician
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of rapidly progressive glomerulonephritis, as defined by at least one of the following: crescent formation in > 50% of glomeruli on renal biopsy, sustained doubling of serum creatinine within 12 weeks of screening, or the investigator's opinion that the participant has rapidly progressive glomerulonephritis
* Greater than 50% of glomeruli with sclerosis on renal biopsy
* Currently requiring hemodialysis or peritoneal dialysis or expected to require dialysis during the study treatment period
* A previous kidney transplant or other organ transplant, or planned transplant within study treatment period

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
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
1/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
HI-Bio Investigational Site - Westmead
Recruitment hospital [2] 0 0
HI-Bio Investigational Site - Woolloongabba
Recruitment hospital [3] 0 0
HI-Bio Investigational Site - Clayton
Recruitment hospital [4] 0 0
HI-Bio Investigational Site - Saint Albans
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3021 - Saint Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Caba
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
HI-Bio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
HI-Bio Clinical Program Lead
Address 0 0
HI-Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
HI-Bio Clinical Program Lead
Address 0 0
Country 0 0
Phone 0 0
1-408-548-7261
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data supporting this study are not publicly available due to the ongoing nature of the clinical development program. Datasets may be available upon reasonable request 18 months after the final clinical study report has been completed and, as appropriate, once the regulatory review of the indication or drug has completed, whichever is later.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT06064929