Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
← catalyst calendarNCT05039840 · readout in 14 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
109actual
Sites
73
Countries
Argentina, Brazil, Chile +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-11-10 | actual | When the study began enrolling |
| Primary completion | 2026-09-03 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-11-24 | estimated | The whole study's end, after follow-up |
| First posted | 2021-09-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Systemic Lupus Erythematosus
Interventions
- Drug: SAR441344 IV
- Drug: SAR441344 SC
- Drug: Placebo IV
- Drug: Placebo SC
Primary outcome
what the primary-completion date above is the date OFPercentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24.
measured At Week 24
Publications
- PMID 39899371 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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