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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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511775-15-00
Acronym
ACT18064
Enrollment
40
Registered
2024-12-09
Start date
2025-01-17
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune system diseases

Brief summary

Percent reduction in urine protein to creatinine ratio (UPCR)

Detailed description

Percentage of participants achieving FSGS partial remission endpoint, Percentage of participants achieving CR, 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, Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970, Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970

Interventions

DRUGFrexalimab
DRUGSAR441344 Placebo - same excipients as test product
DRUGSAR444671 Placebo - Matched Placebo for Test
DRUGSAR442970
DRUGRilzabrutinib
DRUGSAR442970 Placebo - Matched Placebo for Test

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent reduction in urine protein to creatinine ratio (UPCR)—

Secondary

MeasureTime frame
Percentage of participants achieving FSGS partial remission endpoint, Percentage of participants achieving CR, 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, Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970, Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970—

Countries

Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026