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A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging study of Efficacy and Safety of SAR441566 in Adults with Moderate to Severe Plaque Psoriasis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503911-14-00
Acronym
DRI17849
Enrollment
242
Registered
2023-12-15
Start date
2024-01-25
Completion date
2024-11-20
Last updated
2024-12-09

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

Conditions

Psoriasis

Brief summary

Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12

Detailed description

PASI percent change from baseline to week 12, Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) at week 12, Number of participants with Treatment- Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), Plasma pre-dose concentrations of SAR441566, Plasma post-dose concentrations of SAR441566

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12

Secondary

MeasureTime frame
PASI percent change from baseline to week 12, Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) at week 12, Number of participants with Treatment- Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), Plasma pre-dose concentrations of SAR441566, Plasma post-dose concentrations of SAR441566

Countries

Bulgaria, Czechia, Germany, Hungary, Poland, Portugal, Spain

Outcome results

None listed

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