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New eczema shot shows promise in Mid-Stage trial

NCT ID NCT06790121

Symptom relief 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 experimental drug called lunsekimig in 150 adults with moderate-to-severe atopic dermatitis (eczema). Participants received one of three doses of the drug or a placebo as a shot under the skin for 24 weeks. The main goal was to see if the drug reduces eczema severity and itching compared to placebo.

What this could mean

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

Active substance
lunsekimig (SAR443765) injection
What this could lead to
If successful, this could point toward a new monthly injection to ease eczema symptoms like itching and skin redness.
What could go wrong
This is an early Phase 2b trial with only 150 people, so results may not hold up in larger studies. Side effects or lack of significant improvement are possible.

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

150 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2026

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 to 80 years

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 must be 18 to 80 years of age, inclusive, at the time of signing the informed consent. * Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1) * Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments * Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1) * Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline visit (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively). * AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1) * Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1) * Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives \[eg, urea\]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment. * Known history of, or suspected, significant current immunosuppression NOTE: The above information is not intended to contain all considerations relevant to a patient'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.

Dermatitis, atopic

Contacts and locations

Locations

  • Beacon Clinical Research-Site Number: 8400006

    Quincy, Massachusetts, 02169, United States

  • Burien US-WA 98168 Dermatology of Seattle and Bellevue-Site Number: 8400015

    Burien, Washington, 98168, United States

  • Clinical Trials Management LLC-Site Number: 8400010

    Covington, Louisiana, 70433, United States

  • Clinical Trials Research Institute-Site Number: 8400003

    Thousand Oaks, California, 91320, United States

  • DS Research - Kentucky-Site Number: 8400005

    Louisville, Kentucky, 40241, United States

  • DermResearch-Site Number: 8400014

    Austin, Texas, 78759, United States

  • Driven Research LLC-Site Number: 8400020

    Coral Gables, Florida, 33134, United States

  • Health Concepts-Site Number: 8400025

    Rapid City, South Dakota, 57702, United States

  • Icahn School of Medicine at Mount Sinai-Site Number: 8400023

    New York, New York, 10029, United States

  • Indiana Clinical Trials Center, P.C.-Site Number: 8400018

    Plainfield, Indiana, 46168, United States

  • Integrative Skin Science and Research-Site Number: 8400002

    Sacramento, California, 95815, United States

  • Investigational Site Number: 0203001

    Prague, 128 00, Czechia

  • Investigational Site Number: 0203002

    Prague, 160 00, Czechia

  • Investigational Site Number: 0203003

    Prague, 101 00, Czechia

  • Investigational Site Number: 0203004

    Prague, 128 00, Czechia

  • Investigational Site Number: 3920001

    Ōta-ku, 160-0023, Japan

  • Investigational Site Number: 3920002

    Mibu, 321-0293, Japan

  • Investigational Site Number: 3920003

    Fukuoka, 812-8582, Japan

  • Investigational Site Number: 3920004

    Kofu, 400-8506, Japan

  • Investigational Site Number: 3920005

    Asahikawa-shi, 070-8610, Japan

  • Investigational Site Number: 3920006

    Nerima-ku, 177-0041, Japan

  • Investigational Site Number: 3920007

    Yokohama, 221-0825, Japan

  • Investigational Site Number: 3920008

    Tachikawa-shi, 190-0023, Japan

  • Investigational Site Number: 6160001

    Mikołów, 43-190, Poland

  • Investigational Site Number: 6160002

    Warsaw, 02-953, Poland

  • Investigational Site Number: 6160003

    Katowice, 40-748, Poland

  • Investigational Site Number: 6160004

    Szczecin, 70-332, Poland

  • Investigational Site Number: 6160005

    Wroclaw, 50-224, Poland

  • Investigational Site Number: 6160006

    Bydgoszcz, 85-231, Poland

  • Investigational Site Number: 6160007

    Katowice, 40-611, Poland

  • Investigational Site Number: 6160009

    Poznan, 60-192, Poland

  • Investigational Site Number: 6160010

    Jelenia Góra, 58-506, Poland

  • Investigational Site Number: 6160011

    Nowa Sól, 67-100, Poland

  • Investigational Site Number: 6160012

    Sosnowiec, 41-200, Poland

  • Investigational Site Number: 6160013

    Lublin, 20-011, Poland

  • Investigational Site Number: 6160014

    Bochnia, 32-700, Poland

  • Investigational Site Number: 6160015

    Ostrowiec Swietokrzyskie, 27-400, Poland

  • Investigational Site Number: 6160016

    Łodź, 91-495, Poland

  • Investigational Site Number: 6160017

    Warsaw, 01-142, Poland

  • Investigational Site Number: 6160018

    Warsaw, 02-172, Poland

  • Medisearch LLC-Site Number: 8400017

    Saint Joseph, Missouri, 64506, United States

  • Optima Research-Site Number: 8400019

    Plainfield, Indiana, 46168, United States

  • Options Research Group-Site Number: 8400012

    West Lafayette, Indiana, 47906, United States

  • Progressive Clinical Research-Site Number: 8400001

    San Antonio, Texas, 78213, United States

  • Red River Research Partners-Site Number: 8400008

    Fargo, North Dakota, 58103, United States

  • Revival Research Institute, LLC-Site Number: 8400021

    Evans, Georgia, 30809, United States

  • Skin Cancer and Dermatology Institute-Site Number: 8400011

    Reno, Nevada, 89509, United States

  • Skin Care Research-Site Number: 8400013

    Boca Raton, Florida, 33486, United States

  • Somerset Skin Centre-Site Number: 8400009

    Troy, Michigan, 48084, United States

  • Southern Indiana Clinical Trials-Site Number: 8400024

    New Albany, Indiana, 47150, United States

  • T. Joseph Raoof MD Inc-Site Number: 8400004

    Encino, California, 91436, United States

  • Treasure Valley Medical Research-Site Number: 8400026

    Boise, Idaho, 83706, United States

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