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TERMINATED
NCT06058156
PHASE2

Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Interventions

DRUG

SAR444656 (KT-474)

Oral Tablet

DRUG

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