Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT06058156
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2023-11-09
2026-08-18
Brief Summary
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Participants will be randomized to receive SAR444656 dose 1, dose 2, dose 3 or matching placebo.
Participants who meet inclusion/exclusion criteria will be stratified for randomization by severity of AD (moderate \[baseline EASI score \<22\] versus severe \[baseline EASI score ≥22\]).
The total duration of study is approximately 24 weeks, including 1 to 4 weeks for screening, 16 weeks for double-blind study treatment and 4 weeks for follow-up.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR444656 dose 1
Participants will receive SAR444656 dose 1 orally
SAR444656 (KT-474)
Oral Tablet
SAR444656 dose 2
Participants will receive SAR444656 dose 2 orally
SAR444656 (KT-474)
Oral Tablet
SAR444656 dose 3
Participants will receive SAR444656 dose 3 orally
SAR444656 (KT-474)
Oral Tablet
Placebo
Participants will receive placebo orally
Placebo
Oral Tablet
Interventions
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SAR444656 (KT-474)
Oral Tablet
Placebo
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* EASI ≥12 at screening and at baseline visit
* vIGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visit.
* AD involvement ≥10% of BSA at screening and baseline visit
* Baseline PP-NRS ≥4
* Participants must have documented history within 6 months prior to baseline visit, of either inadequate response or inadvisability to topical medications
* Participants must have applied daily topical emollient (moisturizer) for at least the 7 consecutive days immediately before the baseline visit. Participants should continue using daily moisturizers during the study.
* Participants must be willing and able to complete the electronic diary for the duration of the study as required by the study protocol.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
* Any active or chronic infection requiring systemic treatment within 4 weeks prior to baseline
* Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* History of solid organ or stem cell transplant.
* Participants with history of splenectomy.
* Participants with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed.
* Family history of sudden death or long QT syndrome.
* History of congenital or drug-induced long QT syndrome.
* Congestive heart failure (NYHA Class 2-4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.
* History of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
* History of ventricular fibrillation, ventricular tachycardia, Torsades de Pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
* Uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mm Hg or consistent diastolic blood pressure ≥90 mm Hg despite antihypertensive medication.
* Participants had major surgery within 4 weeks prior to the screening or have planned any elective major surgery during the study.
* Having received any of protocol-specified prohibited therapy (Topical or systemic) within the specified timeframe prior to the baseline visit.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Kymera Therapeutics, Inc.
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Locations
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Clear Dermatology & Aesthetics Center- Site Number : 8400003
Scottsdale, Arizona, United States
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
ARA Professionals- Site Number : 8400017
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
ACRC Trials - Carrollton - Hunt - PPDS- Site Number : 8400012
Carrollton, Texas, United States
Investigational Site Number : 2030002
Ostrava, , Czechia
Investigational Site Number : 2030001
Pardubice, , Czechia
Investigational Site Number : 2030003
Prague, , Czechia
Investigational Site Number : 2760007
Heidelberg, Baden-Wurttemberg, Germany
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 : 2760010
Dessau, Saxony-Anhalt, Germany
Investigational Site Number : 2760001
Berlin, , Germany
Investigational Site Number : 3000001
Pavlos Melas, Thessaloniki, Greece
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 : 6160011
Lodz, Lódzkie, Poland
Investigational Site Number : 6160001
Lodz, Lódzkie, 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
Investigational Site Number : 6160010
Lodz, , Poland
Investigational Site Number : 4100002
Cheonan-si, Chungcheongnam-do, South Korea
Investigational Site Number : 4100001
Ansan-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100004
Seongbuk-Gu, Seoul-teukbyeolsi, South Korea
Countries
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Related Links
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ACT17754 Plain Language Results Summary
Other Identifiers
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2023-504346-66
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1287-6919
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACT17754
Identifier Type: -
Identifier Source: org_study_id