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

December 4, 2025 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ostrava, Czechia, 702 00
        • Investigational Site Number : 2030002
      • Pardubice, Czechia, 530 02
        • Investigational Site Number : 2030001
      • Prague, Czechia, 150 00
        • Investigational Site Number : 2030003
  • Germany
      • Berlin, Germany, 13353
        • Investigational Site Number : 2760001
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Investigational Site Number : 2760007
    • Bavaria
      • Munich, Bavaria, Germany, 80337
        • Investigational Site Number : 2760009
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Investigational Site Number : 2760008
    • Lower Saxony
      • Buxtehude, Lower Saxony, Germany, 21614
        • Investigational Site Number : 2760002
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
        • Investigational Site Number : 2760003
      • Remscheid, North Rhine-Westphalia, Germany, 42897
        • Investigational Site Number : 2760006
    • Saxony-Anhalt
      • Dessau, Saxony-Anhalt, Germany, 06847
        • Investigational Site Number : 2760010
  • Greece
      • Thessaloniki, Greece, 546 43
        • Investigational Site Number : 3000002
    • Thessaloniki
      • Pavlos Melas, Thessaloniki, Greece, 564 29
        • Investigational Site Number : 3000001
  • Poland
      • Lodz, Poland, 90-302
        • Investigational Site Number : 6160010
    • Lesser Poland Voivodeship
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Investigational Site Number : 6160006
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-449
        • Investigational Site Number : 6160012
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
        • Investigational Site Number : 6160002
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-436
        • Investigational Site Number : 6160001
      • Lodz, Lódzkie, Poland, 90-127
        • Investigational Site Number : 6160011
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • Investigational Site Number : 6160007
      • Warsaw, Masovian Voivodeship, Poland, 02-758
        • Investigational Site Number : 6160005
    • Pomeranian Voivodeship
      • Chojnice, Pomeranian Voivodeship, Poland, 89-600
        • Investigational Site Number : 6160003
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Investigational Site Number : 6160004
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-040
        • Investigational Site Number : 6160009
  • South Korea
    • Chungcheongnam-do
      • Cheonan-si, Chungcheongnam-do, South Korea, 330721
        • Investigational Site Number : 4100002
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Investigational Site Number : 4100001
    • Seoul-teukbyeolsi
      • Seongbuk-Gu, Seoul-teukbyeolsi, South Korea, 02841
        • Investigational Site Number : 4100004
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Clear Dermatology & Aesthetics Center- Site Number : 8400003
    • Florida
      • Boynton Beach, Florida, United States, 33436
        • Encore Medical Research of Boynton Beach- Site Number : 8400002
      • Doral, Florida, United States, 33122
        • Revival Research - Doral- Site Number : 8400007
      • Hollywood, Florida, United States, 33024
        • Encore Medical Research - 6600 Taft St- Site Number : 8400004
      • Miami, Florida, United States, 33162
        • Sullivan Dermatology- Site Number : 8400001
      • Miami, Florida, United States, 33176-1032
        • ARA Professionals- Site Number : 8400017
      • Weston, Florida, United States, 33331
        • Encore Medical Research - Weston- Site Number : 8400008
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Wayne Health - Dearborn- Site Number : 8400009
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Montefiore- Site Number : 8400006
    • Texas
      • Carrollton, Texas, United States, 75010-4632
        • ACRC Trials - Carrollton - Hunt - PPDS- Site Number : 8400012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Oral Tablet
Experimental: SAR444656 dose 1
Participants will receive SAR444656 dose 1 orally
Drug: SAR444656 (KT-474)
Oral Tablet
Experimental: SAR444656 dose 2
Participants will receive SAR444656 dose 2 orally
Drug: SAR444656 (KT-474)
Oral Tablet
Experimental: SAR444656 dose 3
Participants will receive SAR444656 dose 3 orally
Drug: SAR444656 (KT-474)
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in EASI
Time Frame: Week 16
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 Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs
Time Frame: Up to Week 20
Up to Week 20
Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points
Time Frame: Week 16
Week 16
Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline)
Time Frame: Week 16
Week 16
Absolute change from baseline in EASI
Time Frame: Week 16
Week 16
Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline)
Time Frame: Week 16
Week 16
Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline)
Time Frame: Week 16
Week 16
Change from baseline in percent body surface area (BSA) affected by AD
Time Frame: Week 16
Week 16
Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by ≥4 points from baseline
Time Frame: Week 16
Week 16
Percent change from baseline in weekly average of daily PP-NRS
Time Frame: Week 16
Week 16
Absolute change from baseline in weekly average of daily PP-NRS
Time Frame: Week 16
Week 16
Plasma SAR444656 concentration
Time Frame: Week 0, Week 1, Week 2, Week 4, and Week 16
Week 0, Week 1, Week 2, Week 4, and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Kymera Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Actual)

October 23, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT17754
  • 2023-504346-66 (Registry Identifier: CTIS)
  • U1111-1287-6919 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe