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New pill for eczema shows promise in early trial – but study halted

NCT ID NCT06058156

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral medication called SAR444656 in 70 adults with moderate to severe atopic dermatitis (eczema) that was not well controlled with topical treatments. Participants received one of three doses of the drug or a placebo for 16 weeks. The goal was to see if the drug could reduce eczema severity and itching. However, the trial was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR444656 (KT-474) oral tablet
What this could lead to
If successful, this could point toward a new oral treatment option for moderate to severe eczema that is not well controlled with creams.
What could go wrong
This trial was terminated early, so we may not get clear results. It is still in Phase 2, meaning it is early-stage and may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

70 people

The number who actually took part.

Started

Nov 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

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

    Carrollton, Texas, 75010-4632, United States

  • ARA Professionals- Site Number : 8400017

    Miami, Florida, 33176-1032, United States

  • Clear Dermatology & Aesthetics Center- Site Number : 8400003

    Scottsdale, Arizona, 85255, United States

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

    Hollywood, Florida, 33024, United States

  • Encore Medical Research - Weston- Site Number : 8400008

    Weston, Florida, 33331, United States

  • Encore Medical Research of Boynton Beach- Site Number : 8400002

    Boynton Beach, Florida, 33436, United States

  • Investigational Site Number : 2030001

    Pardubice, 530 02, Czechia

  • Investigational Site Number : 2030002

    Ostrava, 702 00, Czechia

  • Investigational Site Number : 2030003

    Prague, 150 00, Czechia

  • Investigational Site Number : 2760001

    Berlin, 13353, Germany

  • Investigational Site Number : 2760002

    Buxtehude, Lower Saxony, 21614, Germany

  • Investigational Site Number : 2760003

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Investigational Site Number : 2760006

    Remscheid, North Rhine-Westphalia, 42897, Germany

  • Investigational Site Number : 2760007

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Investigational Site Number : 2760008

    Frankfurt am Main, Hesse, 60590, Germany

  • Investigational Site Number : 2760009

    Munich, Bavaria, 80337, Germany

  • Investigational Site Number : 2760010

    Dessau, Saxony-Anhalt, 06847, Germany

  • Investigational Site Number : 3000001

    Pavlos Melas, Thessaloniki, 564 29, Greece

  • Investigational Site Number : 3000002

    Thessaloniki, 546 43, Greece

  • Investigational Site Number : 4100001

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

  • Investigational Site Number : 4100002

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

  • Investigational Site Number : 4100004

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

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 90-436, Poland

  • Investigational Site Number : 6160002

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Investigational Site Number : 6160003

    Chojnice, Pomeranian Voivodeship, 89-600, Poland

  • Investigational Site Number : 6160004

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Investigational Site Number : 6160005

    Warsaw, Masovian Voivodeship, 02-758, Poland

  • Investigational Site Number : 6160006

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Investigational Site Number : 6160007

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • Investigational Site Number : 6160009

    Katowice, Silesian Voivodeship, 40-040, Poland

  • Investigational Site Number : 6160010

    Lodz, 90-302, Poland

  • Investigational Site Number : 6160011

    Lodz, Lódzkie, 90-127, Poland

  • Investigational Site Number : 6160012

    Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

  • Revival Research - Doral- Site Number : 8400007

    Doral, Florida, 33122, United States

  • Sullivan Dermatology- Site Number : 8400001

    Miami, Florida, 33162, United States

  • UPMC Montefiore- Site Number : 8400006

    Pittsburgh, Pennsylvania, 15213, United States

  • Wayne Health - Dearborn- Site Number : 8400009

    Dearborn, Michigan, 48126, United States

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Other studies related to the condition(s) this trial covers.