Enter your ZIP code:

Please enter a 5 digit zipcode
No results...

Entering your zip code helps us to provide information and results that are more relevant to you.

Your privacy is important to us. By continuing, you agree to our Privacy Policy.





A study to evaluate the efficacy and safety of frexalimab, SAR442970, or rilzabrutinib in participa

Nephrology
Ramy Hanna
A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of frexalimab, amlitelimab, and rilzabrutnib in patients with primary focal segmental glomerulosclerosis or minimal change disease
Kidney - Nephrology

Study Description

Eligibility

  1. Biopsy-proven primary FSGS or primary MCD.
  2. UPCR greater than or equal to 3 g/g at screening.
  3. eGFR greater than or equal to 45 mL/min/1.73 m^2 at screening.
  4. Documented history of UPCR reduction by greater than or equal to 40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was greater than or equal to 3.5 g/g.
  5. Less than or equal to 10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
  6. On stable dose of RAAS inhibitors for greater than or equal to 4 weeks prior to screening (if applicable); starting RAAS inhibitors treatment will not be allowed during the double-blind or OLE treatment period.
  7. On stable dose of SGLT2 inhibitor for greater than or equal to 4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment will not be allowed during the double-blind or OLE treatment periods.
  8. Body weight within 45 to 120 kg (inclusive) at screening.
  1. Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
  2. Collapsing variant of FSGS.
  3. 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.

A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.