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

NCT06058156 | Terminated Phase 2 DMC FDA Drug

• 3 other identifiers: ACT177542023-504346-66U1111-1287-6919
• Study Type: interventional
• Target: 70
• Locations: 6 countries
• Sites: 37

Brief Summary

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group Phase 2, 4-arm study in adult participants with moderate to severe AD who are inadequately controlled with topical therapies or for whom such topical therapies are inadvisable and who are candidates for systemic therapy. 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in EASI

  Eczema area severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  Week 16

Secondary Outcomes (11)

• Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points

  Week 16

• Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline)

  Week 16

• Absolute change from baseline in EASI

  Week 16

• Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline)

  Week 16

• Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline)

  Week 16

Study Arms (4)

SAR444656 dose 1

EXPERIMENTAL

Participants will receive SAR444656 dose 1 orally

Drug: SAR444656 (KT-474)

SAR444656 dose 2

EXPERIMENTAL

Participants will receive SAR444656 dose 2 orally

Drug: SAR444656 (KT-474)

SAR444656 dose 3

EXPERIMENTAL

Participants will receive SAR444656 dose 3 orally

Drug: SAR444656 (KT-474)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally

Drug: Placebo

Interventions

SAR444656 (KT-474) DRUG

Oral Tablet

SAR444656 dose 1; SAR444656 dose 2; SAR444656 dose 3

Placebo DRUG

Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with atopic dermatitis as defined by the American Academy of Dermatology Consensus Criteria for at least 1 year before the baseline visit.
• 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.

You may not qualify if:

• Presence of other skin conditions that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus
• 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.

Sponsors & Collaborators

• Sanofi: lead
• Kymera Therapeutics, Inc.: collaborator

Study Sites (37)

Clear Dermatology & Aesthetics Center- Site Number : 8400003

Scottsdale, Arizona, 85255, United States

Location

Encore Medical Research of Boynton Beach- Site Number : 8400002

Boynton Beach, Florida, 33436, United States

Location

Revival Research - Doral- Site Number : 8400007

Doral, Florida, 33122, United States

Location

Encore Medical Research - 6600 Taft St- Site Number : 8400004

Hollywood, Florida, 33024, United States

Location

Sullivan Dermatology- Site Number : 8400001

Miami, Florida, 33162, United States

Location

ARA Professionals- Site Number : 8400017

Miami, Florida, 33176-1032, United States

Location

Encore Medical Research - Weston- Site Number : 8400008

Weston, Florida, 33331, United States

Location

Wayne Health - Dearborn- Site Number : 8400009

Dearborn, Michigan, 48126, United States

Location

UPMC Montefiore- Site Number : 8400006

Pittsburgh, Pennsylvania, 15213, United States

Location

ACRC Trials - Carrollton - Hunt - PPDS- Site Number : 8400012

Carrollton, Texas, 75010-4632, United States

Location

Investigational Site Number : 2030002

Ostrava, 702 00, Czechia

Location

Investigational Site Number : 2030001

Pardubice, 530 02, Czechia

Location

Investigational Site Number : 2030003

Prague, 150 00, Czechia

Location

Investigational Site Number : 2760007

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Investigational Site Number : 2760009

Munich, Bavaria, 80337, Germany

Location

Investigational Site Number : 2760008

Frankfurt am Main, Hesse, 60590, Germany

Location

Investigational Site Number : 2760002

Buxtehude, Lower Saxony, 21614, Germany

Location

Investigational Site Number : 2760003

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Investigational Site Number : 2760006

Remscheid, North Rhine-Westphalia, 42897, Germany

Location

Investigational Site Number : 2760010

Dessau, Saxony-Anhalt, 06847, Germany

Location

Investigational Site Number : 2760001

Berlin, 13353, Germany

Location

Investigational Site Number : 3000001

Pavlos Melas, Thessaloniki, 564 29, Greece

Location

Investigational Site Number : 3000002

Thessaloniki, 546 43, Greece

Location

Investigational Site Number : 6160006

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Investigational Site Number : 6160012

Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

Location

Investigational Site Number : 6160002

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Investigational Site Number : 6160011

Lodz, Lódzkie, 90-127, Poland

Location

Investigational Site Number : 6160001

Lodz, Lódzkie, 90-436, Poland

Location

Investigational Site Number : 6160007

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Investigational Site Number : 6160005

Warsaw, Masovian Voivodeship, 02-758, Poland

Location

Investigational Site Number : 6160003

Chojnice, Pomeranian Voivodeship, 89-600, Poland

Location

Investigational Site Number : 6160004

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Investigational Site Number : 6160009

Katowice, Silesian Voivodeship, 40-040, Poland

Location

Investigational Site Number : 6160010

Lodz, 90-302, Poland

Location

Investigational Site Number : 4100002

Cheonan-si, Chungcheongnam-do, 330721, South Korea

Location

Investigational Site Number : 4100001

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Investigational Site Number : 4100004

Seongbuk-Gu, Seoul-teukbyeolsi, 02841, South Korea

Location

Related Links

• ACT17754 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: November 9, 2023
• Primary Completion: October 23, 2025
• Study Completion: November 20, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

GR (2); KR (3); PL (11); US (10); CZ (3); DE (8)