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New eczema drug shows promise in Long-Term trial

NCT ID NCT05769777

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing the long-term safety and effectiveness of a drug called amlitelimab for people aged 12 and older with moderate to severe atopic dermatitis (eczema). Participants receive injections of amlitelimab for up to 5 years, and researchers monitor for side effects and how well the drug controls the skin condition. The goal is to see if amlitelimab can be a safe, long-term treatment option for those who haven't responded well to other therapies.

What this could mean

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

Active substance
amlitelimab
What this could lead to
If it works, this could provide a long-term treatment option for people with moderate to severe eczema that is not controlled by current therapies.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results may not prove effectiveness. Long-term use may carry unknown risks.

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

999 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Jun 2031

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: * Participant must be at least 12 years of age inclusive, at the time of signing the informed consent. * Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline. * Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit). * Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2. * Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2. * AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2. * Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2. * Able and willing to comply with requested study visits and procedures. * Body weight must be greater than or equal to 25 kg. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding. Exclusion Criteria: * Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement * Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline). * History of solid organ or stem cell transplant. * Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed. * Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study. * Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments. * 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); and any infection which as per Investigator's opinion precludes the participant's participation in the study. * Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline. * Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit. * Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit. * Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening. * In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit. * In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study. * History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. 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.

Dermatitis, atopic

Contacts and locations

Locations

  • Advanced Medical Research - Atlanta- Site Number : 8400044

    Atlanta, Georgia, 30342, United States

  • Allervie Clinical Research - Birmingham- Site Number : 8400050

    Birmingham, Alabama, 35209, United States

  • Caribbean Medical Research Center- Site Number : 8400028

    San Juan, 00918, Puerto Rico

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

    Salvador, Estado de Bahia, 41820-020, Brazil

  • Children's Hospital Colorado - Aurora- Site Number : 8400041

    Aurora, Colorado, 80045, United States

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425, Brazil

  • Clinical Research Trials of Florida- Site Number : 8400054

    Tampa, Florida, 33607, United States

  • Dermatology Research Center of Oklahoma- Site Number : 8400035

    Tulsa, Oklahoma, 74132, United States

  • Dermatology Trial Associates- Site Number : 8400027

    Bryant, Arkansas, 72022, United States

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, São Paulo, 09060-650, Brazil

  • Florida Pharmaceutical Research and Associates- Site Number : 8400018

    Miami, Florida, 33143, United States

  • Florida Research Center- Site Number : 8400011

    Miami, Florida, 33174, United States

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Georgia Skin & Cancer Clinic- Site Number : 8400048

    Savannah, Georgia, 31419, United States

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008

    Ribeirão Preto, São Paulo, 14049-900, Brazil

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

    Curitiba, Paraná, 80060-900, Brazil

  • IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004

    Rio de Janeiro, 22470-220, Brazil

  • IMMUNOe International Research Centers - Centennial- Site Number : 8400024

    Centennial, Colorado, 80112, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1181, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320005

    Buenos Aires, 1427, Argentina

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320008

    Buenos Aires, 1023, Argentina

  • Investigational Site Number : 0320009

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320022

    General Pico, La Pampa Province, 6360, Argentina

  • Investigational Site Number : 0360001

    Sydney, New South Wales, 2010, Australia

  • Investigational Site Number : 0360002

    Kogarah, New South Wales, 2217, Australia

  • Investigational Site Number : 1240001

    Calgary, Alberta, T2G 1B1, Canada

  • Investigational Site Number : 1240002

    Montreal, Quebec, H3G 2S6, Canada

  • Investigational Site Number : 1240003

    Richmond Hill, Ontario, L4B 1L1, Canada

  • Investigational Site Number : 1240004

    Peterborough, Ontario, K9J 5K2, Canada

  • Investigational Site Number : 1240006

    Québec, Quebec, G1W 4R4, Canada

  • Investigational Site Number : 1240008

    Mississauga, Ontario, L5H 1G9, Canada

  • Investigational Site Number : 1240009

    Etobicoke, Ontario, M8X 1Y9, Canada

  • Investigational Site Number : 1240010

    Québec, Quebec, G1V 4X7, Canada

  • Investigational Site Number : 1240011

    Oakville, Ontario, L6J 7W5, Canada

  • Investigational Site Number : 1240012

    Toronto, Ontario, M3H 5Y8, Canada

  • Investigational Site Number : 1240044

    Saskatoon, Saskatchewan, S7T 0G3, Canada

  • Investigational Site Number : 1240051

    Vancouver, British Columbia, V6t 2b5, 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 : 1520004

    Valdivia, Los Ríos Region, 5110683, Chile

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 7500588, Chile

  • Investigational Site Number : 1520009

    Osorno, Los Lagos Region, 5311523, Chile

  • Investigational Site Number : 1520010

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1520011

    Santiago, Reg Metropolitana de Santiago, 7500505, Chile

  • Investigational Site Number : 1520013

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236, Chile

  • Investigational Site Number : 1520014

    Chillan, 3800761, Chile

  • Investigational Site Number : 1560001

    Shanghai, 200040, China

  • Investigational Site Number : 1560008

    Changchun, 130041, China

  • Investigational Site Number : 1560010

    Taiyuan, 030001, China

  • Investigational Site Number : 1560011

    Yiwu, 322000, China

  • Investigational Site Number : 1560012

    Yinchuan, 750004, China

  • Investigational Site Number : 1560013

    Jingzhou, 434020, China

  • Investigational Site Number : 1560014

    Chengdu, 610017, China

  • Investigational Site Number : 1560015

    Beijing, 100045, China

  • Investigational Site Number : 1560016

    Changsha, 410007, China

  • Investigational Site Number : 1560018

    Suzhou, 215006, China

  • Investigational Site Number : 1560019

    Xinxiang, 453100, China

  • Investigational Site Number : 1560028

    Zhenjiang, 212000, China

  • Investigational Site Number : 1560044

    Hangzhou, 310003, China

  • Investigational Site Number : 1560072

    Fuzhou, 350001, China

  • Investigational Site Number : 1560073

    Taizhou, 318000, China

  • Investigational Site Number : 1560074

    Guangzhou, 510120, China

  • Investigational Site Number : 1580001

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    New Taipei City, 235, Taiwan

  • Investigational Site Number : 1580006

    Hsinchu, 300, Taiwan

  • Investigational Site Number : 1580007

    Taichung, 404, 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 : 2030003

    Prague, 100 34, Czechia

  • Investigational Site Number : 2030006

    Prague, 160 00, Czechia

  • Investigational Site Number : 2030007

    Prague, 180 81, Czechia

  • Investigational Site Number : 2032102

    Prague, 100 00, Czechia

  • Investigational Site Number : 2032104

    Ostrava, 702 00, Czechia

  • Investigational Site Number : 2032105

    Nový Jičín, 741 01, Czechia

  • Investigational Site Number : 2080001

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2500001

    Lille, 59037, France

  • Investigational Site Number : 2500002

    Toulouse, 31059, France

  • Investigational Site Number : 2500003

    Paris, 75010, France

  • Investigational Site Number : 2500004

    Créteil, 94010, France

  • Investigational Site Number : 2500005

    Marseille, 13885, France

  • Investigational Site Number : 2500006

    Pierre-Bénite, 69495, France

  • Investigational Site Number : 2500009

    Nantes, 44093, France

  • Investigational Site Number : 2760009

    Bad Bentheim, 48455, Germany

  • Investigational Site Number : 2760010

    Osnabrück, 49074, Germany

  • Investigational Site Number : 2760019

    Witten, 58453, Germany

  • Investigational Site Number : 2760020

    Augsburg, 86150, Germany

  • Investigational Site Number : 2760021

    Rostock, 18055, Germany

  • Investigational Site Number : 2762201

    Münster, 48149, Germany

  • Investigational Site Number : 2762203

    Berlin, 10117, Germany

  • Investigational Site Number : 2762205

    Dresden, 01307, Germany

  • Investigational Site Number : 3560002

    Nashik, 422101, India

  • Investigational Site Number : 3560004

    Mangaluru, 575002, India

  • Investigational Site Number : 3560005

    Kolkata, 700073, India

  • Investigational Site Number : 3560006

    Bengaluru, 560004, India

  • Investigational Site Number : 3560007

    Bikaner, 334001, India

  • Investigational Site Number : 3560008

    Surat, 395002, India

  • Investigational Site Number : 3560011

    Kochi, 682040, India

  • Investigational Site Number : 3800002

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 3800003

    Milan, Milano, 20122, Italy

  • Investigational Site Number : 3800004

    Naples, Napoli, 80138, Italy

  • Investigational Site Number : 3800005

    Brescia, 25123, Italy

  • Investigational Site Number : 3800006

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 3800007

    Rome, Roma, 00161, Italy

  • Investigational Site Number : 3800008

    Vicenza, 36100, Italy

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023, Japan

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293, Japan

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324, Japan

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825, Japan

  • Investigational Site Number : 3923114

    Obihiro, Hokkaido, 080-0013, 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 : 4100003

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05030, South Korea

  • Investigational Site Number : 4100016

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Investigational Site Number : 4100018

    Incheon, Incheon-gwangyeoksi, 21565, South Korea

  • Investigational Site Number : 4840001

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840008

    Durango, 34000, Mexico

  • Investigational Site Number : 5280001

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number : 5280002

    Breda, 4818 CK, Netherlands

  • Investigational Site Number : 5280004

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 6160001

    Chorzów, Silesian Voivodeship, 41-500, Poland

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Investigational Site Number : 6160007

    Warsaw, Masovian Voivodeship, 02-962, Poland

  • Investigational Site Number : 6160009

    Warsaw, Masovian Voivodeship, 02-625, Poland

  • Investigational Site Number : 6160012

    Lublin, Lublin Voivodeship, 20-573, Poland

  • Investigational Site Number : 6160014

    Lodz, Lódzkie, 90-436, Poland

  • Investigational Site Number : 6162411

    Warsaw, Masovian Voivodeship, 01-142, Poland

  • Investigational Site Number : 7100002

    Cape Town, 7700, South Africa

  • Investigational Site Number : 7100003

    Pretoria, 0009, South Africa

  • Investigational Site Number : 7100004

    Boksburg, 1459, South Africa

  • Investigational Site Number : 7100005

    Middelburg, 1055, South Africa

  • Investigational Site Number : 7100006

    Kempton Park, 1619, South Africa

  • Investigational Site Number : 7100007

    Johannesburg, 2196, South Africa

  • Investigational Site Number : 7100009

    Cape Town, 7708, South Africa

  • Investigational Site Number : 7100010

    Cape Town, 7533, South Africa

  • Investigational Site Number : 7100011

    Cape Town, 7530, South Africa

  • Investigational Site Number : 7100012

    Durban, 3630, South Africa

  • Investigational Site Number : 7100014

    Pretoria, 0157, South Africa

  • Investigational Site Number : 7100015

    Durban, 4058, South Africa

  • Investigational Site Number : 7240002

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Investigational Site Number : 7240006

    Valencia, 46026, Spain

  • Investigational Site Number : 7240022

    Sabadell, Barcelona [Barcelona], 08208, Spain

  • Investigational Site Number : 7242501

    Córdoba, 14004, Spain

  • Investigational Site Number : 7242503

    Madrid, 28046, Spain

  • Investigational Site Number : 7242505

    Alicante, 03010, Spain

  • Investigational Site Number : 7560002

    Buochs, 6374, Switzerland

  • Investigational Site Number : 7920005

    Manisa, 45030, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    London, England, NW3 2QG, United Kingdom

  • Investigational Site Number : 8260002

    Edinburgh, EH8 9YL, United Kingdom

  • Investigational Site Number : 8260004

    Sheffield, S10 2TH, United Kingdom

  • Investigational Site Number : 8262601

    London, London, City of, SE1 9RT, United Kingdom

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

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

  • Kentucky Advanced Medical Research- Site Number : 8400014

    Murray, Kentucky, 42071, United States

  • Miami Clinical Research Tower- Site Number : 8400036

    Miami, Florida, 33155, United States

  • Michigan Dermatology Institute - Livonia- Site Number : 8401010

    Livonia, Michigan, 48152, United States

  • Michigan Dermatology Institute - Waterford- Site Number : 8400010

    Waterford, Michigan, 48328, United States

  • Pontifica Universidade Catolica do Parana- Site Number : 0760023

    Curitiba, Paraná, 80215-901, Brazil

  • Private Practice - Dr. Marthe N. Dika- Site Number : 8400022

    Burlington, Wisconsin, 53105, United States

  • Renaissance Research and Medical Group- Site Number : 8400006

    Cape Coral, Florida, 33991, United States

  • Research Solutions of Arizona- Site Number : 8400020

    Litchfield Park, Arizona, 85340, United States

  • Sneeze Wheeze & Itch Associates- Site Number : 8400002

    Normal, Illinois, 61761, United States

  • Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053

    San Antonio, Texas, 78218, United States

  • The Children's Hospital of Philadelphia- Site Number : 8400009

    Philadelphia, Pennsylvania, 19104, United States

  • The Derm Institute of West Michigan- Site Number : 8400043

    Caledonia, Michigan, 49316, United States

  • University Dermatology Trials- Site Number : 8400052

    Newport Beach, California, 92660, United States

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