A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
← catalyst calendarNCT06647069 · readout in 1,041 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
62estimated
Sites
7
Countries
Australia, Bosnia and Herzegovina, New Zealand +1
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 | 2025-03-27 | actual | When the study began enrolling |
| Primary completion | 2029-06-25 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-06-25 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Systemic Lupus Erythematosus (SLE)
- Rheumatoid Arthritis (RA)
Intervention
- Drug: SAR448501 — also filed as DR-0201
Primary outcomes
what the primary-completion date above is the date OFIncidence of treatment-emergent adverse events (TEAEs)
measured Baseline to Week 52 (End of Study (EOS))
Incidence of potentially clinically significant abnormalities (PCSAs)
measured Baseline to Week 52 (EOS)
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