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Testing SAR444656 for adults with moderate to severe atopic dermatitis

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

Phase 2 Interventional Sanofi · NCT06058156

This study is testing a new treatment called SAR444656 to see if it helps adults with moderate to severe eczema who haven't found relief from other creams.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Locations30 sites (Scottsdale, Arizona and 29 other locations)
Trial IDNCT06058156 on ClinicalTrials.gov

What this trial studies

This is a multinational, multicenter, double-blind, placebo-controlled Phase 2 study evaluating SAR444656 in adult participants suffering from moderate to severe atopic dermatitis (AD) who have not responded adequately to topical therapies. Participants will be randomized into four groups to receive either one of three doses of SAR444656 or a matching placebo. The study will last approximately 24 weeks, including a screening phase, a treatment phase of 16 weeks, and a 4-week follow-up period. Participants will be stratified based on the severity of their AD to ensure balanced groups.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate to severe atopic dermatitis who have had inadequate responses to topical therapies or for whom such therapies are inadvisable.

Not a fit: Patients with mild atopic dermatitis or those who have not used topical emollients consistently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new systemic therapy option for patients with moderate to severe atopic dermatitis who have not responded to existing topical treatments.

How similar studies have performed: Other studies have shown promise with similar systemic therapies for atopic dermatitis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic Dermatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.