Atopic DermatitisPhase 2ADVANTANCT06058156
Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing SAR444656 (KT-474) in people with Atopic Dermatitis, run by Sanofi at 22 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- SAR444656 (KT-474)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 9 Nov 2023to 20 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 was moderate and 4 was severe) at screening and baseline visit.
- AD involvement ≥10% of BSA at screening and baseline visit
- Baseline PP-NRS ≥4
- Participants must had documented history within 6 months prior to baseline visit, of either inadequate response or inadvisability to topical medications
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- Participants must had applied daily topical emollient (moisturizer) for at least the 7 consecutive days immediately before the baseline visit. Participants should continued using daily moisturizers during the study.
- Participants must be willing and completed the electronic diary for the duration of the study as required by the study protocol.
- Contraceptive used by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Poland8 sites
Investigational Site Number : 6160003
Chojnice, Pomeranian Voivodeship, 89-600
Investigational Site Number : 6160004
Gdansk, Pomeranian Voivodeship, 80-546
Investigational Site Number : 6160009
Katowice, Silesian Voivodeship, 40-040
Investigational Site Number : 6160006
Tarnów, Lesser Poland Voivodeship, 33-100
Investigational Site Number : 6160007
Warsaw, Masovian Voivodeship, 00-874
Investigational Site Number : 6160005
Warsaw, Masovian Voivodeship, 02-758
Investigational Site Number : 6160012
Wroclaw, Lower Silesian Voivodeship, 50-449
Investigational Site Number : 6160002
Wroclaw, Lower Silesian Voivodeship, 50-566
United States7 sites
Encore Medical Research of Boynton Beach- Site Number : 8400002
Boynton Beach, Florida, 33436
Wayne Health - Dearborn- Site Number : 8400009
Dearborn, Michigan, 48126
Revival Research - Doral- Site Number : 8400007
Doral, Florida, 33122
Encore Medical Research - 6600 Taft St- Site Number : 8400004
Hollywood, Florida, 33024
Sullivan Dermatology- Site Number : 8400001
Miami, Florida, 33162
UPMC Montefiore- Site Number : 8400006
Pittsburgh, Pennsylvania, 15213
Encore Medical Research - Weston- Site Number : 8400008
Weston, Florida, 33331
Germany6 sites
Investigational Site Number : 2760001
Berlin, 13353
Investigational Site Number : 2760003
Bochum, North Rhine-Westphalia, 44791
Investigational Site Number : 2760002
Buxtehude, Lower Saxony, 21614
Investigational Site Number : 2760008
Frankfurt am Main, Hesse, 60590
Investigational Site Number : 2760009
Munich, Bavaria, 80337
Investigational Site Number : 2760006
Remscheid, North Rhine-Westphalia, 42897
About this study
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
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.
Read more
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.
- Conditions
- Atopic Dermatitis
- Being tested
- SAR444656 (KT-474), Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR444656 (KT-474)Drug
Oral Tablet
PlaceboDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo matched to SAR444656 tablet orally from Day 1 to Week 16. Receives: Drug: Placebo |
| SAR444656 Dose Level 1 | Experimental | Participants received SAR444656 Dose Level 1 tablet orally from Day 1 to Week 16. Dose Level 1 is the highest dose level. Receives: Drug: SAR444656 (KT-474) |
| SAR444656 Dose Level 2 | Experimental | Participants received SAR444656 Dose Level 2 tablet orally from Day 1 to Week 16. Dose Level 2 is the lower dose level. Receives: Drug: SAR444656 (KT-474) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Eczema Area and Severity Index at Week 16
EASI is an Investigator-assessed validated tool to measure extent (area) and severity of AD based on 4 disease characteristics (erythema [E], induration/papulation [I], excoriation [X] and lichenification [L]) in 4 different body areas using 4-point scale: 0 (absent) to 3 (severe). Extent of involvement of AD in 4 body regions: head/neck, trunk, UE and LE is assessed. For each region, percentage of body surface area (BSA) is converted to area score: 0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%. EASI score is calculated as: (E+I+X+L) x area score. Total EASI score is the weighted total of region EASI using weights 10% (head/neck), 20% (UE), 30% (trunk) and 40% (LE); ranges from 0 to 72 and higher scores indicate increased extent and severity of AD. Baseline was defined as last available value before the first dose of double-blind study drug.
Measured: Baseline (Day 1) and Week 16
Secondary outcomes (11)
Percentage of Participants With Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
The vIGA-AD is an Investigator-led assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe). Higher vIGA-AD scores indicate more severe disease. Percentage of participants with a score of 0 or 1 and a reduction from baseline of >=2 points at Week 16 are presented here. Baseline was defined as last available value before the first dose of double-blind study drug. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) and Week 16
Percentage of Participants Achieving 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
EASI is an Investigator-assessed validated tool to measure extent (area) and severity of AD based on 4 disease characteristics (E, I, X and L) in 4 different body areas using 4-point scale: 0 (absent) to 3 (severe). Extent of involvement of AD in 4 body regions: head/neck, trunk, UE and LE is assessed. For each region, percentage of BSA is converted to area score: 0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%. EASI score is calculated as: (E+I+X+L) x area score. Total EASI score is the weighted total of region EASI using weights 10% (head/neck), 20% (UE), 30% (trunk) and 40% (LE); ranges from 0 to 72 and higher scores indicate increased extent and severity of AD. EASI-75 was defined as reduction of EASI score by >=75% from baseline. Baseline was defined as last available value before the first dose of double-blind study drug. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) and Week 16
Absolute Change From Baseline in Eczema Area and Severity Index at Week 16
EASI is an Investigator-assessed validated tool to measure extent (area) and severity of AD based on 4 disease characteristics (E, I, X and L) in 4 different body areas using 4-point scale: 0 (absent) to 3 (severe). Extent of involvement of AD in 4 body regions: head/neck, trunk, UE and LE is assessed. For each region, percentage of BSA is converted to area score: 0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%. EASI score is calculated as: (E+I+X+L) x area score. Total EASI score is the weighted total of region EASI using weights 10% (head/neck), 20% (UE), 30% (trunk) and 40% (LE); ranges from 0 to 72 and higher scores indicate increased extent and severity of AD. Baseline was defined as last available value before the first dose of double-blind study drug.
Measured: Baseline (Day 1) and Week 16
Percentage of Participants Achieving 50% Reduction From Baseline in Eczema Area and Severity Index (EASI-50) at Week 16
EASI is an Investigator-assessed validated tool to measure extent (area) and severity of AD based on 4 disease characteristics (E, I, X and L) in 4 different body areas using 4-point scale: 0 (absent) to 3 (severe). Extent of involvement of AD in 4 body regions: head/neck, trunk, UE and LE is assessed. For each region, percentage of BSA is converted to area score: 0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%. EASI score is calculated as: (E+I+X+L) x area score. Total EASI score is the weighted total of region EASI using weights 10% (head/neck), 20% (UE), 30% (trunk) and 40% (LE); ranges from 0 to 72 and higher scores indicate increased extent and severity of AD. EASI-50 was defined as reduction of EASI score by >=50% from baseline. Baseline was defined as last available value before the first dose of double-blind study drug. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) and Week 16
Percentage of Participants Achieving 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16
EASI is an Investigator-assessed validated tool to measure extent (area) and severity of AD based on 4 disease characteristics (E, I, X and L) in 4 different body areas using 4-point scale: 0 (absent) to 3 (severe). Extent of involvement of AD in 4 body regions: head/neck, trunk, UE and LE is assessed. For each region, percentage of BSA is converted to area score: 0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%. EASI score is calculated as: (E+I+X+L) x area score. Total EASI score is the weighted total of region EASI using weights 10% (head/neck), 20% (UE), 30% (trunk) and 40% (LE); ranges from 0 to 72 and higher scores indicate increased extent and severity of AD. EASI-90 was defined as reduction of EASI score by >=90% from baseline. Baseline was defined as last available value before the first dose of double-blind study drug. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) and Week 16
Change From Baseline in Percent Body Surface Area Affected by Atopic Dermatitis at Week 16
The BSA affected by AD is assessed by the Investigator for each section of the body. Each body region is weighted using the 'rule of nines': head and neck (9%), anterior trunk (18%), back (18%), upper limbs (18%), lower limbs (36%), and genitals (1%); reported as a percentage of all major body sections combined. Baseline was defined as last available value before the first dose of double-blind study drug.
Measured: Baseline (Day 1) and Week 16
Percentage of Participants With >=4-Point Reduction From Baseline in Weekly Average of Daily Peak Pruritus-Numeric Rating Scale (PP-NRS) at Week 16
The PP-NRS is a validated single item 0-10 numerical rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours. The participant is asked about the severity of his/her pruritus on a 0 to 10 scale, where 0=no itch and 10=worst itch imaginable. Higher scores indicate more severe disease. The weekly average PP-NRS score was calculated as the average of 7 days preceding the actual visit day of measurement with a minimum of 4 completions in their daily diary. Baseline was defined as the average of all available daily non-missing scores obtained during the 7 days prior to randomization. Percentages are rounded off to tenth decimal place.
Measured: Baseline (Day 1) and Week 16
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus-Numeric Rating Scale at Week 16
The PP-NRS is a validated single item 0-10 numerical rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours. The participant is asked about the severity of his/her pruritus on a 0 to 10 scale, where 0=no itch and 10=worst itch imaginable. Higher scores indicate more severe disease. The weekly average PP-NRS score was calculated as the average of 7 days preceding the actual visit day of measurement with a minimum of 4 completions in their daily diary. Baseline was defined as the average of all available daily non-missing scores obtained during the 7 days prior to randomization.
Measured: Baseline (Day 1) and Week 16
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus-Numeric Rating Scale at Week 16
The PP-NRS is a validated single item 0-10 numerical rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours. The participant is asked about the severity of his/her pruritus on a 0 to 10 scale, where 0=no itch and 10=worst itch imaginable. Higher scores indicate more severe disease. The weekly average PP-NRS score was calculated as the average of 7 days preceding the actual visit day of measurement with a minimum of 4 completions in their daily diary. Baseline was defined as the average of all available daily non-missing scores obtained during the 7 days prior to randomization.
Measured: Baseline (Day 1) and Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs) and TEAEs Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. A TEAE was an AE that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) was one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Measured: From first dose of study drug (Day 1) up to 20 weeks
Serum Concentrations of SAR444656
Blood samples were collected at specified timepoints to determine serum concentration of SAR444656.
Measured: Pre-dose, 2, 4 and 7 hours post-dose at Weeks 0 and 2; pre-dose and 7 hours post-dose at Weeks 1, 4 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start9 Nov 2023
- Primary completion23 Oct 2025
- Study completion20 Nov 2025
Why it stopped: Sponsor decision. Not related to safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kymera Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058156
- Sponsor's protocol ID
- ACT17754
- Other IDs
- 2023-504346-66, U1111-1287-6919, 2023-503910-60, 2023
- Acronym
- ADVANTA
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2023
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06058156
- Acronym / sponsor ID
- ADVANTA / ACT17754
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision. Not related to safety concern.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Kymera Therapeutics, Inc.
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 3 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo matched to SAR444656 tablet orally from Day 1 to Week 16. |
| SAR444656 Dose Level 1 | Experimental | Drug: SAR444656 (KT-474)Participants received SAR444656 Dose Level 1 tablet orally from Day 1 to Week 16. Dose Level 1 is the highest dose level. |
| SAR444656 Dose Level 2 | Experimental | Drug: SAR444656 (KT-474)Participants received SAR444656 Dose Level 2 tablet orally from Day 1 to Week 16. Dose Level 2 is the lower dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 was moderate and 4 was severe) at screening and baseline visit.
- AD involvement ≥10% of BSA at screening and baseline visit
- Baseline PP-NRS ≥4
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR444656 (KT-474)Oral Tablet | Drug | SAR444656 Dose Level 1, SAR444656 Dose Level 2 |
| PlaceboOral Tablet | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Eczema Area and Severity Index at Week 16
Time frame: Baseline (Day 1) and Week 16
EASI is an Investigator-assessed validated tool to measure extent (area) and severity of AD based on 4 disease characteristics (erythema [E], induration/papulation [I], excoriation [X] and lichenification [L]) in 4 different body areas using 4-point scale: 0 (absent) to 3 (severe). Extent of involvement of AD in 4 body regions: head/neck, trunk, UE and LE is assessed. For each region, percentage of body surface area (BSA) is converted to area score: 0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%. EASI score is calculated as: (E+I+X+L) x area score. Total EASI score is the weighted total of region EASI using weights 10% (head/neck), 20% (UE), 30% (trunk) and 40% (LE); ranges from 0 to 72 and higher scores indicate increased extent and severity of AD. Baseline was defined as last available value before the first dose of double-blind study drug.
11 secondary outcomes
Percentage of Participants With Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
Time frame: Baseline (Day 1) and Week 16
Percentage of Participants Achieving 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
Time frame: Baseline (Day 1) and Week 16
Absolute Change From Baseline in Eczema Area and Severity Index at Week 16
Time frame: Baseline (Day 1) and Week 16
Percentage of Participants Achieving 50% Reduction From Baseline in Eczema Area and Severity Index (EASI-50) at Week 16
Time frame: Baseline (Day 1) and Week 16
Percentage of Participants Achieving 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16
Time frame: Baseline (Day 1) and Week 16
Change From Baseline in Percent Body Surface Area Affected by Atopic Dermatitis at Week 16
Time frame: Baseline (Day 1) and Week 16
Percentage of Participants With >=4-Point Reduction From Baseline in Weekly Average of Daily Peak Pruritus-Numeric Rating Scale (PP-NRS) at Week 16
Time frame: Baseline (Day 1) and Week 16
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus-Numeric Rating Scale at Week 16
Time frame: Baseline (Day 1) and Week 16
Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus-Numeric Rating Scale at Week 16
Time frame: Baseline (Day 1) and Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs) and TEAEs Leading to Study Drug Discontinuation
Time frame: From first dose of study drug (Day 1) up to 20 weeks
Serum Concentrations of SAR444656
Time frame: Pre-dose, 2, 4 and 7 hours post-dose at Weeks 0 and 2; pre-dose and 7 hours post-dose at Weeks 1, 4 and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ACT17754 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR444656 (KT-474) in people with Atopic Dermatitis, run by Sanofi at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Poland, United States, Germany, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Eczema Area and Severity Index at Week 16 (time frame: Baseline (Day 1) and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.