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New shot offers hope for Tough-to-Treat eczema

NCT ID NCT06241118

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 3 times

Summary

This study tests an injectable drug called amlitelimab for people aged 12 and older with moderate-to-severe eczema that hasn't improved with other treatments. Participants will also use standard steroid creams. The goal is to see if the drug can clear or nearly clear the skin compared to a placebo over 36 weeks.

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

464 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy. * 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

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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

  • A.O.U. di Modena -Site Number: 3800021

    Modena, 41125, Italy

  • Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057

    Ogden, Utah, 84405, United States

  • Apex Clinical Research - Jacksonville- Site Number : 8401332

    Jacksonville, Florida, 32256, United States

  • Arkansas Dermatology - North Little Rock- Site Number : 8401244

    North Little Rock, Arkansas, 72117, United States

  • Arlington Research Center- Site Number : 8401248

    Arlington, Texas, 76011, United States

  • Avita Clinical Research- Site Number : 8401073

    Tampa, Florida, 33613, United States

  • Azienda ospedaliera di Perugia - Ospedale "Santa Maria della Misericordia"-Site Number: 3800015

    Perugia, 06129, Italy

  • Center for Advanced Studies and Technology-Site Number: 3800016

    Chieti, 66100, Italy

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538, United States

  • Center for Dermatology and Plastic Surgery- Site Number : 8401119

    Scottsdale, Arizona, 85260, United States

  • Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014

    São Paulo, 04020-060, Brazil

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

    Salvador, Estado de Bahia, 41820-020, Brazil

  • Cheyenne Skin Clinic- Site Number : 8401234

    Cheyenne, Wyoming, 82009, United States

  • Children's Wisconsin- Site Number : 8401246

    Milwaukee, Wisconsin, 53226, United States

  • Cincinnati Children's Hospital Medical Center- Site Number : 8401279

    Cincinnati, Ohio, 45229, United States

  • Clever Medical Research- Site Number : 8401160

    Miami, Florida, 33126, United States

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425, Brazil

  • Clinical Research of Philadelphia- Site Number : 8401193

    Philadelphia, Pennsylvania, 19114, United States

  • Dawes Fretzin Clinical Research- Site Number : 8401015

    Indianapolis, Indiana, 46256, United States

  • Dermatology Research Associates - Los Angeles- Site Number : 8401092

    Los Angeles, California, 90045, United States

  • Encino Research Center- Site Number : 8401042

    Encino, California, 91436, United States

  • Encore Medical Research of Boynton Beach- Site Number : 8401030

    Boynton Beach, Florida, 33436, United States

  • Equity Medical - Bowling Green- Site Number : 8401296

    Bowling Green, Kentucky, 42104, United States

  • Equity Medical- Site Number : 8401239

    New York, New York, 10023, United States

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, São Paulo, 09060-650, Brazil

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

    St. Petersburg, Florida, 33714, United States

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

    São Paulo, 01323-020, Brazil

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320011

    Buenos Aires, 1035, Argentina

  • Investigational Site Number : 0320014

    Córdoba, 5000, Argentina

  • Investigational Site Number : 0320019

    Buenos Aires, 1426, Argentina

  • Investigational Site Number : 0360006

    Melbourne, Victoria, 3004, Australia

  • Investigational Site Number : 0360008

    Melbourne, Victoria, 3002, Australia

  • Investigational Site Number : 1240016

    Edmonton, Alberta, T5J 3S9, Canada

  • Investigational Site Number : 1240019

    Calgary, Alberta, T2W 4X9, Canada

  • Investigational Site Number : 1240020

    Hamilton, Ontario, L8L 3C3, Canada

  • Investigational Site Number : 1240028

    Regina, Saskatchewan, S4V 1R9, Canada

  • Investigational Site Number : 1240035

    Toronto, Ontario, M5A 3R6, Canada

  • Investigational Site Number : 1240053

    London, Ontario, N6A 5R9, Canada

  • Investigational Site Number : 1240054

    Toronto, Ontario, M5m 3z8, Canada

  • Investigational Site Number : 1240058

    Burlington, Ontario, L7L 6W6, 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 : 1520010

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1560001

    Shanghai, 200040, China

  • Investigational Site Number : 1560002

    Hangzhou, 310006, China

  • Investigational Site Number : 1560005

    Shanghai, 200443, China

  • Investigational Site Number : 1560009

    Hangzhou, 310009, China

  • Investigational Site Number : 1560021

    Guangzhou, 510018, China

  • Investigational Site Number : 1560024

    Ningbo, 315010, China

  • Investigational Site Number : 1560031

    Changchun, 130021, China

  • Investigational Site Number : 1560032

    Xi'an, 710004, China

  • Investigational Site Number : 1560034

    Nanyang, 473014, China

  • Investigational Site Number : 1560035

    Ningbo, 315010, China

  • Investigational Site Number : 1560036

    Guangzhou, 510100, China

  • Investigational Site Number : 1560038

    Wuhan, 430030, China

  • Investigational Site Number : 1560041

    Shenyang, 110001, China

  • Investigational Site Number : 1560044

    Hangzhou, 310003, China

  • Investigational Site Number : 1560057

    Chongqing, 400016, China

  • Investigational Site Number : 1580001

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580003

    Taipei, Taiwan

  • Investigational Site Number : 1583201

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 1583203

    Taoyuan City, 333, Taiwan

  • Investigational Site Number : 2500001

    Lille, 59037, France

  • Investigational Site Number : 2500004

    Créteil, 94010, France

  • Investigational Site Number : 2500011

    Bordeaux, 33000, France

  • Investigational Site Number : 2500012

    Rouen, 76031, France

  • Investigational Site Number : 2500014

    Clermont-Ferrand, 63100, France

  • Investigational Site Number : 2500016

    Saint-Pierre, 97448, Reunion

  • Investigational Site Number : 2500017

    Paris, 75010, France

  • Investigational Site Number : 2760019

    Witten, 58453, Germany

  • Investigational Site Number : 2760022

    Frankfurt, 60590, Germany

  • Investigational Site Number : 2761001

    Dresden, 01307, Germany

  • Investigational Site Number : 2761002

    Lübeck, 23562, Germany

  • Investigational Site Number : 2762202

    Blankenfelde-Mahlow, 15831, Germany

  • Investigational Site Number : 2762203

    Berlin, 10117, Germany

  • Investigational Site Number : 3000001

    Athens, 16121, Greece

  • Investigational Site Number : 3000002

    Thessaloniki, 54643, Greece

  • Investigational Site Number : 3000004

    Athens, 124 62, Greece

  • Investigational Site Number : 3000005

    Athens, 16121, Greece

  • Investigational Site Number : 3760005

    Beersheba, 8457108, Israel

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760008

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3800020

    Turin, Torino, 10126, Italy

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023, Japan

  • Investigational Site Number : 3920007

    Hiroshima, 734-8551, Japan

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293, Japan

  • Investigational Site Number : 3923109

    Habikino, Osaka, 583-8588, Japan

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324, Japan

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 07441, South Korea

  • Investigational Site Number : 4100002

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

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100014

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Investigational Site Number : 4100015

    Bupyeong-Gu, Incheon-gwangyeoksi, 21431, South Korea

  • Investigational Site Number : 4840003

    Veracruz, 91900, Mexico

  • Investigational Site Number : 4840011

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160002

    Lublin, Lublin Voivodeship, 20-363, Poland

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Investigational Site Number : 6162411

    Warsaw, Masovian Voivodeship, 01-142, Poland

  • Investigational Site Number : 6162417

    Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

  • Investigational Site Number : 6820001

    Riyadh, 12713, Saudi Arabia

  • Investigational Site Number : 7240002

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Investigational Site Number : 7240017

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 7240020

    Seville, Sevilla, 41013, Spain

  • Investigational Site Number : 7242503

    Madrid, 28046, Spain

  • Investigational Site Number : 7242505

    Alicante, 03010, Spain

  • Investigational Site Number : 7840001

    Abu Dhabi, 6222, United Arab Emirates

  • Investigational Site Number : 7840002

    Abu Dhabi, United Arab Emirates

  • Investigational Site Number : 7841002

    Abu Dhabi, 51900, United Arab Emirates

  • Investigational Site Number : 7920002

    Istanbul, 34098, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920008

    Gaziantep, 27310, Turkey (Türkiye)

  • Investigational Site Number : 8260003

    Portsmouth, Hampshire, PO3 6DW, United Kingdom

  • Investigational Site Number : 8260008

    Liverpool, L7 8XP, United Kingdom

  • Investigational Site Number : 8260009

    Leeds, North Yorkshire, Ls7 4sa, United Kingdom

  • Investigational Site Number : 8260010

    Nottingham, Nottinghamshire, NG17 4JL, United Kingdom

  • Investigational Site Number : 8260012

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Investigational Site Number : 8260013

    Bristol, Bristol, City of, BS2 8HW, United Kingdom

  • Investigational Site Number : 8260015

    London, England, SW10 9NH, United Kingdom

  • Investigational Site Number : 8262603

    London, England, E11 1NR, United Kingdom

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

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

  • LA Universal Research Center- Site Number : 8401064

    Los Angeles, California, 90057, United States

  • Long Beach Clinical Trials- Site Number : 8401188

    Long Beach, California, 90806, United States

  • MI Skin Center- Site Number : 8401307

    Northville, Michigan, 48167, United States

  • McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288

    Bellaire, Texas, 77401, United States

  • Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282

    Charleston, South Carolina, 29425, United States

  • North Sound Dermatology- Site Number : 8401280

    Mill Creek, Washington, 98012, United States

  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038

    Skokie, Illinois, 60077, United States

  • Northwestern University- Site Number : 8401285

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University (OHSU)- Site Number : 8401247

    Portland, Oregon, 97239, United States

  • Paddington Testing Company- Site Number : 8401041

    Philadelphia, Pennsylvania, 19103, United States

  • Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

    Wheat Ridge, Colorado, 80033, United States

  • Rady Children's Hospital- Site Number : 8401291

    San Diego, California, 92123, United States

  • Reveal Research Institute - Dallas- Site Number : 8401219

    Dallas, Texas, 75235, United States

  • Sadick Research Group - New York - Park Avenue- Site Number : 8401050

    New York, New York, 10075, United States

  • Schweiger Dermatology Group - East Windsor- Site Number : 8401338

    East Windsor, New Jersey, 08520, United States

  • Skin Specialists- Site Number : 8401068

    Omaha, Nebraska, 68144, United States

  • St. Jude Clinical Research- Site Number : 8401287

    Doral, Florida, 33172, United States

  • Tandem Clinical Research - Metairie- Site Number : 8401187

    Metairie, Louisiana, 70006, United States

  • The University of New Mexico- Site Number : 8401263

    Albuquerque, New Mexico, 87106, United States

  • Therapeutics Clinical Research- Site Number : 8401283

    San Diego, California, 92123, United States

  • UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"-Site Number : 3800017

    Naples, 80131, Italy

  • University Dermatology Trials- Site Number : 8401339

    Newport Beach, California, 92660, United States

  • University of Alabama at Birmingham- Site Number : 8401267

    Birmingham, Alabama, 35233, United States

  • University of Michigan Health System - Ann Arbor- Site Number : 8401290

    Ann Arbor, Michigan, 48109, United States

  • Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

    Norfolk, Virginia, 23502, United States

More trials for these conditions

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