Frexalimab
Drugfrexalimab treatment
NCT Number: NCT06500702
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig or rilzabrutinib compared with placebo in participants with primary FSGS or MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.
Interested in participating?
Request Info16 year–75 year
All sexes
Interventional
Phase 2
Investigational Site Number : 0320001, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
frexalimab treatment
brivekimig treatment
rilzabrutinib treatment
placebo treatment
Time frame: From baseline to Week 12
Time frame: At Week 12
Defined as UPCR ≤1.5 g/g and >40 % reduction of UPCR from baseline
Time frame: At Week 12
Defined as UPCR ≤0.3 g/g
Time frame: Treatment emergent period, up to Week 48
TEAEs, including clinically significant changes in vital signs, electrocardiogram [ECG], and laboratory evaluation
Time frame: Up to Week 48
Time frame: Up to Week 48
Contact information is provided by the study sponsor or research team.
Sanofi
Industry
A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
Acronym: RESULT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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