Phase 1b/2 Study of IV Sarilumab in Adult With RA
← catalyst calendarNCT07704580 · readout in 799 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
140estimated
Sites
4
Country
United States
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 | 2026-07-02 | actual | When the study began enrolling |
| Primary completion | 2028-10-26 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-10-26 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Rheumatoid Arthritis
Interventions
- Drug: Sarilumab, SAR153191 SC — also filed as Kevzara®
- Drug: Sarilumab, SAR153191 IV
Primary outcomes
what the primary-completion date above is the date OFPart A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses
measured from Baseline up to Week 6
Part A: Assessment of PK parameters of sarilumab in serum: maximum concentration [Cmax] for IV doses
measured from Baseline up to Week 6
Part B: Assessment of PK parameters of sarilumab in serum: plasma concentration at steady state (Ctrough ss)
measured from Baseline up to Week 30
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