Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug shot shows promise for tough eczema in large trial

NCT ID NCT06224348

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study tested a new drug called amlitelimab, given as a shot under the skin, for people aged 12 and older with moderate-to-severe atopic dermatitis (eczema) that wasn't controlled by creams. The trial included 643 participants and compared amlitelimab to a placebo, while everyone also used standard topical treatments. The goal was to see if the drug could clear or nearly clear the skin and reduce eczema severity after 24 weeks.

What this could mean

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

Active substance
amlitelimab (a drug given as a shot under the skin)
What this could lead to
If it works, this could offer a new treatment option for people with moderate-to-severe eczema that isn't controlled by creams alone.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. Even if effective, it may not work for everyone, and side effects are possible with any new drug.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

643 people

The number who actually took part.

Started

Jan 2024

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

12 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 must be 12 years of age (when signing informed consent form) * Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria) * Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening) * v-IGA-AD of 3 or 4 at baseline visit * EASI score of 16 or higher at baseline * AD involvement of 10% or more of BSA at baseline * Weekly average of daily PP-NRS of ≥ 4 at baseline visit. * Able and willing to comply with requested study visits and procedures * Body weight ≥25 kg Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Skin co-morbidity that would adversely affect the ability to undertake AD assessments * Known history of or suspected significant current immunosuppression * Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline) * History of solid organ or stem cell transplant * Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline * Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit * Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB * Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit * In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening * History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP) The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Dermatitis, atopic are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Acevedo Clinical Research Associates- Site Number : 8401088

    Miami, Florida, 33142, United States

  • Allcutis Research - Portsmouth- Site Number : 8401082

    Portsmouth, New Hampshire, 03801, United States

  • Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078

    Ypsilanti, Michigan, 48197, United States

  • Apex Clinical Research Center- Site Number : 8401237

    Mayfield Heights, Ohio, 44124, United States

  • Avita Clinical Research- Site Number : 8401073

    Tampa, Florida, 33613, United States

  • BRCR Global Gretna- Site Number : 8401243

    Gretna, Louisiana, 70053, United States

  • Cahaba Dermatology & Skin Health Center- Site Number : 8401066

    Birmingham, Alabama, 35244, United States

  • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017

    Vitória, Espírito Santo, 29055-450, Brazil

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

    Salvador, Estado de Bahia, 41820-020, Brazil

  • Cleaver Medical Group- Site Number : 8401138

    Dawsonville, Georgia, 30534, United States

  • Clever Medical Research- Site Number : 8401160

    Miami, Florida, 33126, United States

  • Clinical Research Center of the Carolinas- Site Number : 8401067

    Charleston, South Carolina, 29407, United States

  • Complete Dermatology - Sugar Land- Site Number : 8401061

    Sugar Land, Texas, 77479, United States

  • Cope Family Medicine - Ogden Clinic- Site Number : 8401114

    Bountiful, Utah, 84010, United States

  • Cura Clinical Research- Site Number : 8401141

    Palmdale, California, 93551, United States

  • Dawes Fretzin Clinical Research- Site Number : 8401015

    Indianapolis, Indiana, 46256, United States

  • Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157

    Lee's Summit, Missouri, 64064, United States

  • Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026

    San Antonio, Texas, 78258, United States

  • Encino Research Center- Site Number : 8401042

    Encino, California, 91436, United States

  • Equity Medical- Site Number : 8401239

    New York, New York, 10023, United States

  • Essential Medical Research- Site Number : 8401183

    Tulsa, Oklahoma, 74137, United States

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, 09060-650, Brazil

  • Global Clinical Professionals (GCP)- Site Number : 8401045

    St. Petersburg, Florida, 33705, United States

  • Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010

    São Paulo, 01323-020, Brazil

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital das Clinicas FMUSP- Site Number : 0760012

    São Paulo, 05403-000, Brazil

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015

    Ribeirão Preto, São Paulo, 14049-900, Brazil

  • Icahn School of Medicine at Mount Sinai- Site Number : 8401129

    New York, New York, 10029, United States

  • Integrative Skin Science and Research- Site Number : 8401275

    Sacramento, California, 95815, United States

  • Investigational Site Number : 0320004

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320005

    CABA, Buenos Aires F.D., 1427, Argentina

  • Investigational Site Number : 0320008

    Buenos Aires, 1061, Argentina

  • Investigational Site Number : 0320010

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320011

    Buenos Aires, 1035, Argentina

  • Investigational Site Number : 0320012

    Corrientes, 3400, Argentina

  • Investigational Site Number : 0320013

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320018

    Buenos Aires, 1178, Argentina

  • Investigational Site Number : 0320019

    Buenos Aires, 1056, Argentina

  • Investigational Site Number : 0320020

    San Miguel de Tucumán, 4000, Argentina

  • Investigational Site Number : 1002004

    Pleven, 5800, Bulgaria

  • Investigational Site Number : 1002006

    Sofia, 1592, Bulgaria

  • Investigational Site Number : 1002007

    Dupnitsa, 2600, Bulgaria

  • Investigational Site Number : 1002009

    Sofia, 1431, Bulgaria

  • Investigational Site Number : 1240004

    Peterborough, Ontario, K9J5K2, Canada

  • Investigational Site Number : 1240006

    Québec, Quebec, G1W 4R4, Canada

  • Investigational Site Number : 1240008

    Mississauga, Ontario, L5H 1G9, Canada

  • Investigational Site Number : 1240012

    Toronto, Ontario, M3H 5Y8, Canada

  • Investigational Site Number : 1240030

    Surrey, British Columbia, V3V 0C6, Canada

  • Investigational Site Number : 1240038

    Richmond Hill, Ontario, L4E 4L6, Canada

  • Investigational Site Number : 1240039

    Calgary, Alberta, T2J 7E1, Canada

  • Investigational Site Number : 1240041

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Investigational Site Number : 1240045

    Red Deer, Alberta, T4P 1K4, Canada

  • Investigational Site Number : 1240046

    Kamloops, British Columbia, V1Y 4N7, Canada

  • Investigational Site Number : 1240057

    Brampton, Ontario, L6Z1Y4, Canada

  • Investigational Site Number : 1241106

    Markham, Ontario, L3P 1X2, Canada

  • Investigational Site Number : 1241107

    Waterloo, Ontario, N2J 1C4, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number : 1520006

    Viña del Mar, Valparaiso, 2530900, Chile

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 7500588, Chile

  • Investigational Site Number : 1520009

    Osorno, Reg Metropolitana de Santiago, 5311523, Chile

  • Investigational Site Number : 1520010

    Santiago, 8330032, Chile

  • Investigational Site Number : 1520011

    Santiago, Reg Metropolitana de Santiago, 8380456, Chile

  • Investigational Site Number : 1520012

    Talcahuano, 2687000, Chile

  • Investigational Site Number : 1560003

    Wuxi, 214000, China

  • Investigational Site Number : 1560005

    Shanghai, 200443, China

  • Investigational Site Number : 1560006

    Hangzhou, 310009, China

  • Investigational Site Number : 1560021

    Guangzhou, 510018, China

  • Investigational Site Number : 1560041

    Shenyang, 110001, China

  • Investigational Site Number : 1560043

    Fuzhou, 350005, China

  • Investigational Site Number : 1560044

    Hangzhou, 310003, China

  • Investigational Site Number : 1560047

    Tianjin, 300052, China

  • Investigational Site Number : 1560049

    Wuhan, 430022, China

  • Investigational Site Number : 1560050

    Changsha, 410011, China

  • Investigational Site Number : 1560051

    Nanchang, 330001, China

  • Investigational Site Number : 1560060

    Chengdu, 610072, China

  • Investigational Site Number : 2030008

    Prague, 110 00, Czechia

  • Investigational Site Number : 2030008

    Prague, 110 01, Czechia

  • Investigational Site Number : 2030009

    Pilsen, 323 00, Czechia

  • Investigational Site Number : 2030010

    Olomouc, 779 00, Czechia

  • Investigational Site Number : 2030011

    Prague, 150 00, Czechia

  • Investigational Site Number : 2032104

    Ostrava, 702 00, Czechia

  • Investigational Site Number : 2032105

    Nový Jičín, 741 01, Czechia

  • Investigational Site Number : 2500002

    Toulouse, 31059, France

  • Investigational Site Number : 2500006

    Pierre-Bénite, 69495, France

  • Investigational Site Number : 2500009

    Nantes, 44093, France

  • Investigational Site Number : 2500010

    Romans-sur-Isère, 26102, France

  • Investigational Site Number : 2500011

    Bordeaux, 33000, France

  • Investigational Site Number : 2500012

    Rouen, 76031, France

  • Investigational Site Number : 2500013

    Nice, 06202, France

  • Investigational Site Number : 2500016

    Saint-Pierre, 97410, France

  • Investigational Site Number : 2760009

    Bad Bentheim, 48455, Germany

  • Investigational Site Number : 2760014

    Buxtehude, 21614, Germany

  • Investigational Site Number : 2760016

    Mainz, 55128, Germany

  • Investigational Site Number : 2760017

    Hamburg, 20095, Germany

  • Investigational Site Number : 2760018

    Magdeburg, 39104, Germany

  • Investigational Site Number : 2760019

    Witten, 58453, Germany

  • Investigational Site Number : 2760020

    Augsburg, 86150, Germany

  • Investigational Site Number : 2760021

    Hamburg, 20354, Germany

  • Investigational Site Number : 2762201

    Münster, 48149, Germany

  • Investigational Site Number : 2762208

    Kiel, 24105, Germany

  • Investigational Site Number : 3800003

    Milan, Lombardy, 20122, Italy

  • Investigational Site Number : 3800008

    Pisa, 56126, Italy

  • Investigational Site Number : 3800011

    L’Aquila, 67100, Italy

  • Investigational Site Number : 3800012

    Bologna, 40138, Italy

  • Investigational Site Number : 3800019

    Torette, 60020, Italy

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023, Japan

  • Investigational Site Number : 3920002

    Iruma, Saitama, 350-0495, Japan

  • Investigational Site Number : 3920003

    Kyoto, 606-8507, Japan

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0031, Japan

  • Investigational Site Number : 3920005

    Sagamihara, Kanagawa, 252-0315, Japan

  • Investigational Site Number : 3920006

    Kobe, Hyōgo, 653-0836, Japan

  • Investigational Site Number : 3920008

    Sapporo, Hokkaido, 064-0921, Japan

  • Investigational Site Number : 3920009

    Chitose, Hokkaido, 066-0021, Japan

  • Investigational Site Number : 3920010

    Miyagi-gun, Miyagi, 981-0112, Japan

  • Investigational Site Number : 3920011

    Sendai, Miyagi, 981-3133, Japan

  • Investigational Site Number : 3923102

    Kyoto, 602-8566, Japan

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293, Japan

  • Investigational Site Number : 3923107

    Minato, Tokyo, 108-0014, Japan

  • Investigational Site Number : 3923108

    Kagoshima, 890-0063, Japan

  • Investigational Site Number : 3923109

    Habikino, 583-8588, Japan

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324, Japan

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825, Japan

  • Investigational Site Number : 3923113

    Yokohama, 221-0825, Japan

  • Investigational Site Number : 3923114

    Obihiro, Hokkaido, 080-0013, Japan

  • Investigational Site Number : 7240008

    Bilbao, Bizkaia, 48013, Spain

  • Investigational Site Number : 7240010

    Esplugues de Llobregat, Catalunya [Cataluña], 08950, Spain

  • Investigational Site Number : 7240013

    Madrid, 28031, Spain

  • Investigational Site Number : 7240014

    Vigo, 36206, Spain

  • Investigational Site Number : 7240015

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240019

    Granada, Andalusia, 18012, Spain

  • Investigational Site Number : 7240020

    Seville, Andalusia, 41013, Spain

  • Investigational Site Number : 7240023

    Burjassot, Valenciana, Comunidad, 46100, Spain

  • Investigational Site Number : 7242502

    Manises, Valencia, 46940, Spain

  • Investigational Site Number : 7242505

    Alicante, 03010, Spain

  • Investigational Site Number : 7920001

    Antalya, 07070, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34098, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Istanbul, 34010, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Kayseri, 38039, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920007

    Samsun, 55139, Turkey (Türkiye)

  • Investigational Site Number : 7920008

    Gaziantep, 27310, Turkey (Türkiye)

  • Investigational Site Number : 7920009

    Istanbul, 34662, Turkey (Türkiye)

  • Investigational Site Number : 7920010

    Ankara, 06560, Turkey (Türkiye)

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Johnson Dermatology- Site Number : 8401076

    Fort Smith, Arkansas, 72916, United States

  • Jubilee Clinical Research- Site Number : 8401054

    Las Vegas, Nevada, 89106, United States

  • LA Universal Research Center- Site Number : 8401064

    Los Angeles, California, 90057, United States

  • Marvel Clinical Research- Site Number : 8401102

    Huntington Beach, California, 92647, United States

  • NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038

    Skokie, Illinois, 60076, United States

  • Oakland Medical Center- Site Number : 8401116

    Troy, Michigan, 48085, United States

  • OptiSkin- Site Number : 8401163

    New York, New York, 10128, United States

  • PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023

    Curitiba, Paraná, 80230-130, Brazil

  • Palm Springs Community Health Center- Site Number : 8401264

    Miami Lakes, Florida, 33016, United States

  • SMS Clinical Research- Site Number : 8401182

    Mesquite, Texas, 75149, United States

  • Sienna Dermatology- Site Number : 8401148

    Missouri City, Texas, 77459, United States

  • Skin Care Research - Hollywood- Site Number : 8401071

    Hollywood, Florida, 33021, United States

  • Skin Specialists- Site Number : 8401068

    Omaha, Nebraska, 68144, United States

  • Southern California Dermatology- Site Number : 8401043

    Santa Ana, California, 92701, United States

  • Tanner Clinic - Layton Antelope A- Site Number : 8401151

    Layton, Utah, 84041, United States

  • Texas Dermatology and Laser Specialists- Site Number : 8401131

    San Antonio, Texas, 78218, United States

  • University of South Florida- Site Number : 8401070

    Tampa, Florida, 33612, United States

  • Velocity Clinical Research - New Orleans- Site Number : 8401155

    New Orleans, Louisiana, 70119, United States

  • Vial Health - DermDox Dermatology- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011, United States

More trials for these conditions

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