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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06500702




Registration number
NCT06500702
Ethics application status
Date submitted
8/07/2024
Date registered
15/07/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Scientific title
A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
Secondary ID [1] 0 0
2024-511775-15
Secondary ID [2] 0 0
ACT18064
Universal Trial Number (UTN)
Trial acronym
RESULT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Segmental Glomerulosclerosis 0 0
Glomerulonephritis Minimal Lesion 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - frexalimab
Treatment: Drugs - SAR442970
Treatment: Drugs - rilzabrutinib
Treatment: Drugs - placebo

Experimental: Frexalimab - Frexalimab active dose

Experimental: SAR442970 - SAR442970 active dose

Experimental: Rilzabrutinib - Rilzabrutinib active dose

Placebo comparator: Placebo - Matching placebo


Treatment: Drugs: frexalimab
frexalimab treatment

Treatment: Drugs: SAR442970
SAR442970 treatment

Treatment: Drugs: rilzabrutinib
rilzabrutinib treatment

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

Outcomes
Primary outcome [1] 0 0
Percent reduction in urine protein to creatinine ratio (UPCR)
Timepoint [1] 0 0
From baseline to Week 12
Secondary outcome [1] 0 0
Percentage of participants achieving FSGS partial remission endpoint
Timepoint [1] 0 0
At Week 12
Secondary outcome [2] 0 0
Percentage of participants achieving CR
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events (SAEs), treatment-emergent adverse events of special interest (AESIs) and IMP discontinuation due to TEAEs during the study
Timepoint [3] 0 0
Treatment emergent period, up to Week 48
Secondary outcome [4] 0 0
Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970
Timepoint [4] 0 0
Up to Week 48
Secondary outcome [5] 0 0
Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970
Timepoint [5] 0 0
Up to Week 48

Eligibility
Key inclusion criteria
* Biopsy-proven primary FSGS or primary MCD.
* UPCR =3 g/g at screening.
* eGFR =45 mL/min/1.73 m^2 at screening.
* Documented history of UPCR reduction by =40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was =3.5 g/g.
* =10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
* On stable dose of RAAS inhibitors for =4 weeks prior to screening (if applicable); starting RAAS inhibitors treatment will not be allowed during the double-blind or OLE treatment period.
* On stable dose of SGLT2 inhibitor for =4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment will not be allowed during the double-blind or OLE treatment periods.
* Body weight within 45 to 120 kg (inclusive) at screening.
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
* Collapsing variant of FSGS.
* ESKD requiring dialysis or transplantation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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
19/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/02/2028
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
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
Illinois
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
Minnesota
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
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Córdoba
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Chile
State/province [10] 0 0
Santiago
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Chengdu
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
France
State/province [14] 0 0
Créteil
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Heraklion
Country [20] 0 0
Italy
State/province [20] 0 0
Napoli
Country [21] 0 0
Italy
State/province [21] 0 0
Brescia
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Poland
State/province [23] 0 0
Opole
Country [24] 0 0
Portugal
State/province [24] 0 0
Matosinhos
Country [25] 0 0
Portugal
State/province [25] 0 0
Porto
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona [Barcelona]
Country [27] 0 0
Spain
State/province [27] 0 0
Catalunya [Cataluña]
Country [28] 0 0
Spain
State/province [28] 0 0
Sevilla
Country [29] 0 0
Spain
State/province [29] 0 0
Córdoba
Country [30] 0 0
Spain
State/province [30] 0 0
Valencia
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taichung
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
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/NCT06500702