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Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
Sponsor: Sanofi
Summary
This was a multinational, multicenter, double-blind, placebo-controlled, parallel-group Phase 2, 4-arm study in adult participants with moderate to severe AD who were inadequately controlled with topical therapies or for whom such topical therapies were inadvisable and who were candidates for systemic therapy. Participants were randomized to receive SAR444656 dose 1, dose 2, dose 3 or matching placebo. Participants who met inclusion/exclusion criteria were stratified for randomization by severity of AD (moderate \[baseline EASI score \<22\] versus severe \[baseline EASI score ≥22\]). The total duration of study was approximately 24 weeks, including 1 to 4 weeks for screening, 16 weeks for double-blind study treatment and 4 weeks for follow-up.
Official title: A Multinational, Multicenter, Double-blind, Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-11-09
Completion Date
2025-11-20
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
SAR444656 (KT-474)
Oral Tablet
Placebo
Oral Tablet
Locations (22)
Encore Medical Research of Boynton Beach- Site Number : 8400002
Boynton Beach, Florida, United States
Revival Research - Doral- Site Number : 8400007
Doral, Florida, United States
Encore Medical Research - 6600 Taft St- Site Number : 8400004
Hollywood, Florida, United States
Sullivan Dermatology- Site Number : 8400001
Miami, Florida, United States
Encore Medical Research - Weston- Site Number : 8400008
Weston, Florida, United States
Wayne Health - Dearborn- Site Number : 8400009
Dearborn, Michigan, United States
UPMC Montefiore- Site Number : 8400006
Pittsburgh, Pennsylvania, United States
Investigational Site Number : 2760009
Munich, Bavaria, Germany
Investigational Site Number : 2760008
Frankfurt am Main, Hesse, Germany
Investigational Site Number : 2760002
Buxtehude, Lower Saxony, Germany
Investigational Site Number : 2760003
Bochum, North Rhine-Westphalia, Germany
Investigational Site Number : 2760006
Remscheid, North Rhine-Westphalia, Germany
Investigational Site Number : 2760001
Berlin, Germany
Investigational Site Number : 3000002
Thessaloniki, Greece
Investigational Site Number : 6160006
Tarnów, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160012
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160002
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160007
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160003
Chojnice, Pomeranian Voivodeship, Poland
Investigational Site Number : 6160004
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site Number : 6160009
Katowice, Silesian Voivodeship, Poland