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New shot shows promise for tough eczema cases

NCT ID NCT06130566

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This study tested a new medicine called amlitelimab, given as a shot under the skin, for people aged 12 and older with moderate-to-severe eczema that didn't get better with creams or other treatments. The goal was to see if it can clear or nearly clear the skin and reduce itching and rash compared to a placebo. The study involved 601 participants and lasted up to 24 weeks of treatment, with an option to continue in a follow-up study.

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

601 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

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 either inadequate response or inadvisability 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: * 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 (1 week in the event of superficial skin infections) * 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

  • Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286

    Fort Myers, Florida, 33919, United States

  • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018

    Rio de Janeiro, 22241-180, Brazil

  • CHEAR Center- Site Number : 8401123

    The Bronx, New York, 10459, United States

  • Carbon Health - North Hollywood - NoHo West- Site Number : 8401218

    North Hollywood, California, 91606, United States

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538, 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

  • Cleaver Medical Group Dermatology- Site Number : 8401139

    Cumming, Georgia, 30040, United States

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425, Brazil

  • Clinical Neuroscience Solutions - Orlando - South Delaney Avenue- Site Number : 8401035

    Orlando, Florida, 32806, United States

  • Clinical Research of Philadelphia- Site Number : 8401193

    Philadelphia, Pennsylvania, 19114, United States

  • Dermatology Treatment and Research Center- Site Number : 8401164

    Dallas, Texas, 75230, United States

  • Direct Helpers Research Center- Site Number : 8401056

    Hialeah, Florida, 33012, United States

  • Encore Medical Research- Site Number : 8401030

    Hollywood, Florida, 33021, United States

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, 09060-650, Brazil

  • First OC Dermatology- Site Number : 8401025

    Fountain Valley, California, 92708, United States

  • Florida International Research Center- Site Number : 8401091

    Miami, Florida, 33173, United States

  • Henry Ford Hospital- Site Number : 8401044

    Detroit, Michigan, 48202, United States

  • Hospital São Domingos- Site Number : 0760028

    Bequimão, Maranhão, 65060-645, Brazil

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012

    São Paulo, 05403-000, Brazil

  • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022

    Curitiba, Paraná, 80060-900, Brazil

  • Investigational Site Number : 0320010

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320022

    Buenos Aires, 1012, Argentina

  • Investigational Site Number : 0320023

    Buenos Aires, Buenos Aires F.D., 1028, Argentina

  • Investigational Site Number : 0320024

    SAN Miguel de Tucumã¡n, Tucumán Province, T4000, Argentina

  • Investigational Site Number : 0360006

    Melbourne, Victoria, 3004, Australia

  • Investigational Site Number : 0360007

    Woolloongabba, Queensland, 4102, Australia

  • Investigational Site Number : 0360008

    Melbourne, Victoria, 3002, Australia

  • Investigational Site Number : 0360010

    Westmead, New South Wales, 2145, Australia

  • Investigational Site Number : 0361006

    Traralgon, Victoria, 3844, Australia

  • Investigational Site Number : 1240013

    Toronto, Ontario, M3B 3N1, Canada

  • Investigational Site Number : 1240028

    Regina, Saskatchewan, S4V 1R9, Canada

  • Investigational Site Number : 1240029

    London, Ontario, N6A 2C2, Canada

  • Investigational Site Number : 1240031

    Edmonton, Alberta, T5K 2V4, Canada

  • Investigational Site Number : 1240033

    Ajax, Ontario, L1S 7K8, Canada

  • Investigational Site Number : 1240034

    Ottawa, Ontario, K1H 7X8, Canada

  • Investigational Site Number : 1240035

    Toronto, Ontario, M5A 3R6, Canada

  • Investigational Site Number : 1240036

    Saskatoon, Saskatchewan, S7K 0H6, Canada

  • Investigational Site Number : 1240040

    Surrey, British Columbia, V3R 6A7, Canada

  • Investigational Site Number : 1240043

    Saint-Jérôme, Quebec, J7Z 7E2, Canada

  • Investigational Site Number : 1240055

    Hamilton, Ontario, L8S 1G5, Canada

  • Investigational Site Number : 1241108

    Niagara Falls, Ontario, L2H 1H5, 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, 7500587, Chile

  • Investigational Site Number : 1520009

    Osorno, Reg Metropolitana de Santiago, 5311523, Chile

  • Investigational Site Number : 1520010

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1520011

    Santiago, Reg Metropolitana de Santiago, 8380456, Chile

  • Investigational Site Number : 1520012

    Talcahuano, 2687000, Chile

  • Investigational Site Number : 1560042

    Beijing, 100034, China

  • Investigational Site Number : 1560057

    Chongqing, 400016, China

  • Investigational Site Number : 1560058

    Guangzhou, 510630, China

  • Investigational Site Number : 1560059

    Jinan, 250014, China

  • Investigational Site Number : 1560060

    Chengdu, 610072, China

  • Investigational Site Number : 1560064

    Shenzhen, 518026, China

  • Investigational Site Number : 1560065

    Chongqing, 400065, China

  • Investigational Site Number : 1560068

    Chengdu, 610091, 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 : 1583202

    Taichung, 402, Taiwan

  • Investigational Site Number : 1583203

    Taoyuan City, 333, Taiwan

  • Investigational Site Number : 2500003

    Paris, 75010, France

  • Investigational Site Number : 2500007

    Reims, 51100, France

  • Investigational Site Number : 2500008

    Antony, 92160, France

  • Investigational Site Number : 2500009

    Nantes, 44093, France

  • Investigational Site Number : 2500010

    Romans-sur-Isère, 26102, 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 : 2762201

    Münster, 48149, Germany

  • Investigational Site Number : 2762208

    Kiel, 24105, Germany

  • Investigational Site Number : 3000001

    Athens, 161 21, Greece

  • Investigational Site Number : 3000002

    Thessaloniki, 546 42, Greece

  • Investigational Site Number : 3000003

    Thessaloniki, 564 29, Greece

  • Investigational Site Number : 3000004

    Athens, 124 62, Greece

  • Investigational Site Number : 3560001

    Ahmedabad, 380016, India

  • Investigational Site Number : 3560002

    Nagpur, 440015, India

  • Investigational Site Number : 3560003

    Pune, 411057, India

  • Investigational Site Number : 3560004

    Chandigarh, 160012, India

  • Investigational Site Number : 3560005

    Belagavi, 590002, India

  • Investigational Site Number : 3560006

    Haryāna, 121002, India

  • Investigational Site Number : 3560007

    Kolkata, 700073, India

  • Investigational Site Number : 3560008

    Bengaluru, 560090, India

  • Investigational Site Number : 3760001

    Haifa, 3109601, Israel

  • Investigational Site Number : 3760002

    Petah Tikva, 4941492, Israel

  • Investigational Site Number : 3760003

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760004

    Afula, 1834111, Israel

  • Investigational Site Number : 3760005

    Beersheba, 8457108, Israel

  • Investigational Site Number : 3760006

    Petah Tikva, 4920235, Israel

  • Investigational Site Number : 4100002

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

  • Investigational Site Number : 4100003

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05030, South Korea

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100008

    Daegu, Daegu, 41944, South Korea

  • Investigational Site Number : 4100009

    Suwon, Gyeonggi-do, 16499, South Korea

  • Investigational Site Number : 4100010

    Seoul, Seoul-teukbyeolsi, 01812, South Korea

  • Investigational Site Number : 4100011

    Seoul, Seoul-teukbyeolsi, 06591, South Korea

  • Investigational Site Number : 4100012

    Gwangju, 61453, South Korea

  • Investigational Site Number : 4100013

    Seoul, Seoul-teukbyeolsi, 03080, 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 : 4100017

    Seoul, Seoul-teukbyeolsi, 07804, South Korea

  • Investigational Site Number : 6160002

    Lodz, 90-265, Poland

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Investigational Site Number : 6160004

    Lublin, 20-607, Poland

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Investigational Site Number : 6160007

    Warsaw, 02-962, Poland

  • Investigational Site Number : 6160009

    Warsaw, 02-625, Poland

  • Investigational Site Number : 6160010

    Tarnów, 33-100, Poland

  • Investigational Site Number : 6160011

    Olsztyn, 11-041, Poland

  • Investigational Site Number : 6162406

    Krakow, 31-209, Poland

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

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

  • Javara Research - Thomasville- Site Number : 8401189

    Thomasville, Georgia, 31792, United States

  • Massachusetts General Hospital- Site Number : 8401192

    Boston, Massachusetts, 02114, United States

  • MedPharmics - Covington- Site Number : 8401137

    Covington, Louisiana, 70433, United States

  • MedPharmics - Lafeyette- Site Number : 8401152

    Lafayette, Louisiana, 70508, United States

  • MediSearch Clinical Trials- Site Number : 8401140

    Saint Joseph, Missouri, 64506, United States

  • Metro Boston Clinical Partners- Site Number : 8401128

    Needham, Massachusetts, 02492, United States

  • Miami Dermatology and Laser Research- Site Number : 8401086

    Miami, Florida, 33173, United States

  • Northridge Clinical Trials - Northridge- Site Number : 8401080

    Northridge, California, 91325, United States

  • Onsite Clinical Solutions - Charlotte - Blakeney Park Drive- Site Number : 8401124

    Charlotte, North Carolina, 28277, United States

  • Oregon Medical Research Center- Site Number : 8401017

    Portland, Oregon, 97201, United States

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

    Curitiba, Paraná, 80230-130, Brazil

  • Paddington Testing Company- Site Number : 8401041

    Philadelphia, Pennsylvania, 19103, United States

  • Revival Research - Doral- Site Number : 8401012

    Dearborn, Michigan, 33122, United States

  • Rophe Adult & Pediatric Medicine- Site Number : 8401289

    Union City, Georgia, 30291, United States

  • SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058

    Ridgeland, Mississippi, 39157, United States

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

    New York, New York, 10075, United States

  • Scottsdale Clinical Trials- Site Number : 8401149

    Scottsdale, Arizona, 85260, United States

  • Skin Care Physicians of Georgia - Macon- Site Number : 8401034

    Macon, Georgia, 31217, United States

  • Skin Sciences- Site Number : 8401039

    Louisville, Kentucky, 40217, United States

  • Skin Specialist of Addison- Site Number : 8401208

    Dallas, Texas, 75254, United States

  • Somnos Clinical Research- Site Number : 8401203

    Lincoln, Nebraska, 68510, United States

  • Springville Dermatology - Springville- Site Number : 8401106

    Springville, Utah, 84663, United States

  • St Jude Clinical Research- Site Number : 8401287

    Doral, Florida, 33172, United States

  • Stryde Research - Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas, 76092, United States

  • Sunwise Clinical Research- Site Number : 8401022

    Lafayette, California, 94549, United States

  • Texas Dermatology and Laser Specialists- Site Number : 8401131

    San Antonio, Texas, 78218, United States

  • Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8401225

    Greenville, South Carolina, 29607, United States

  • Universal Dermatology- Site Number : 8401224

    Fairport, New York, 14450, United States

  • Vial Health - DermDox Dermatology- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011, United States

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

    Norfolk, Virginia, 23502, United States

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