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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 to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
Scientific title
An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis
Secondary ID [1] 0 0
HIB-202-101
Secondary ID [2] 0 0
299LE101
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 - Participants will receive two courses of multiple intravenous (IV) doses of felzartamab, separated by a 28-week off-treatment period.

These courses are given in Part 1 and Part 2 of the trial.


Treatment: Drugs: Felzartamab
Administered IV
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 Week 104
Secondary outcome [1] 0 0
Change from Baseline in Urine Protein:Creatinine Ratio (UPCR)
Timepoint [1] 0 0
Baseline, Up to Week 104
Secondary outcome [2] 0 0
Proportion of Participants Who Achieve a Complete Renal Response (CRR)
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (PRR: CRR+PRR)
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Change from Baseline in Serum Creatinine
Timepoint [4] 0 0
Baseline, Up to Week 104
Secondary outcome [5] 0 0
Change from Baseline in Urine Protein
Timepoint [5] 0 0
Baseline, Up to Week 104
Secondary outcome [6] 0 0
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [6] 0 0
Baseline, Up to Week 104
Secondary outcome [7] 0 0
Change from Baseline in eGFR Slope
Timepoint [7] 0 0
Baseline, Up to Week 104
Secondary outcome [8] 0 0
Change from Baseline in Lupus Serologic Markers
Timepoint [8] 0 0
Baseline, Up to Week 104
Secondary outcome [9] 0 0
Felzartamab Serum Concentrations
Timepoint [9] 0 0
Up to Week 104
Secondary outcome [10] 0 0
Number of Participants with Anti-drug Antibodies to Felzartamab
Timepoint [10] 0 0
Baseline, Up to Week 104

Eligibility
Key inclusion criteria
Part 1

* 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)

1. If eGFR is =35 to <45 mL/min/1.73m^2, renal biopsy must be within 6 months of screening and must not have >50% of glomeruli with sclerosis. If the renal biopsy was performed more than 6 months prior to screening, a repeat biopsy must be done during screening after all the other eligibility criteria are met
2. If eGFR is =45 mL/min/1.73 m^2, renal biopsy must be within 1 year prior to screening. If the renal biopsy was performed more than 1 year prior to screening, a repeat biopsy must be done during screening after all the other eligibility criteria are met
* 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

Part 2

* Participants must complete Part 1 of the study to be eligible to participate in Part 2.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1

* 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

Part 2

* Did not complete Part 1 of the study
* Received protocol-prohibited medications in Part 1 such as calcineurin inhibitors (e.g., cyclosporine, tacrolimus, or voclosporin), alkylating agents including cyclophosphamide, or biologic agents other than felzartamab
* Progression of LN (as measured by worsening proteinuria and/or decreasing eGFR) has been observed such that in the opinion of the investigator the participant will not benefit from continuing in Part 2 of the study

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/06/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Monash Health - Melbourne
Recruitment hospital [4] 0 0
Western Health - 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 - Melbourne
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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Capital Federal
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autonoma De Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Cordoba
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Mexico
State/province [14] 0 0
Jalisco
Country [15] 0 0
Mexico
State/province [15] 0 0
Mexico City
Country [16] 0 0
Mexico
State/province [16] 0 0
Yucatan
Country [17] 0 0
Mexico
State/province [17] 0 0
Chihuahua

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
HI-Bio, A Biogen Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US Biogen Clinical Trial Center
Address 0 0
Country 0 0
Phone 0 0
1-866-633-4636
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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