Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

NCT05769777 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: LTS17789U1111-1280-60802022-502188-39
• Study Type: interventional
• Target: 999
• Locations: 25 countries
• Sites: 174

Brief Summary

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including:

• A screening period of up to 2 to 4 weeks
• An open label treatment period of up to 268 weeks (approximately 5 years)
• A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (2)

• Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs)

  Percentage of participants who experienced TEAEs from baseline during the study

  Baseline up to end of study (EOS) (Week 284)

• Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)

  Percentage of participants who experienced TESAEs from baseline during the study

  Baseline up to EOS (Week 284)

Secondary Outcomes (40)

• Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI)

  Baseline up to EOS (Week 284)

• Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG)

  Baseline up to EOS (Week 284)

• Percentage of participants discontinued from study treatment due to Adverse Events (AEs)

  Baseline up to EOS (Week 284)

• Percent change from baseline in Eczema Area and Severity Index (EASI) score

  Baseline to EOS (Week 284)

• Proportion of participants with at least a 75% reduction from baseline in the EASI (EASI-75)

  Baseline to EOS (Week 284)

Study Arms (1)

Amlitelimab

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab

Interventions

Amlitelimab DRUG

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Amlitelimab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (174)

Allervie Clinical Research - Birmingham- Site Number : 8400050

Birmingham, Alabama, 35209, United States

Location

Research Solutions of Arizona- Site Number : 8400020

Litchfield Park, Arizona, 85340, United States

Location

Dermatology Trial Associates- Site Number : 8400027

Bryant, Arkansas, 72022, United States

Location

University Dermatology Trials- Site Number : 8400052

Newport Beach, California, 92660, United States

Location

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

Aurora, Colorado, 80045, United States

Location

IMMUNOe International Research Centers - Centennial- Site Number : 8400024

Centennial, Colorado, 80112, United States

Location

Renaissance Research and Medical Group- Site Number : 8400006

Cape Coral, Florida, 33991, United States

Location

Florida Pharmaceutical Research and Associates- Site Number : 8400018

Miami, Florida, 33143, United States

Location

Miami Clinical Research Tower- Site Number : 8400036

Miami, Florida, 33155, United States

Location

Florida Research Center- Site Number : 8400011

Miami, Florida, 33174, United States

Location

Clinical Research Trials of Florida- Site Number : 8400054

Tampa, Florida, 33607, United States

Location

Advanced Medical Research - Atlanta- Site Number : 8400044

Atlanta, Georgia, 30342, United States

Location

Georgia Skin & Cancer Clinic- Site Number : 8400048

Savannah, Georgia, 31419, United States

Location

Sneeze Wheeze & Itch Associates- Site Number : 8400002

Normal, Illinois, 61761, United States

Location

Kentucky Advanced Medical Research- Site Number : 8400014

Murray, Kentucky, 42071, United States

Location

The Derm Institute of West Michigan- Site Number : 8400043

Caledonia, Michigan, 49316, United States

Location

Michigan Dermatology Institute - Livonia- Site Number : 8401010

Livonia, Michigan, 48152, United States

Location

Michigan Dermatology Institute - Waterford- Site Number : 8400010

Waterford, Michigan, 48328, United States

Location

Dermatology Research Center of Oklahoma- Site Number : 8400035

Tulsa, Oklahoma, 74132, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

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

San Antonio, Texas, 78218, United States

Location

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

Burlington, Wisconsin, 53105, United States

Location

Investigational Site Number : 0320022

General Pico, La Pampa Province, 6360, Argentina

Location

Investigational Site Number : 0320006

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320007

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320008

Buenos Aires, 1023, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320003

Buenos Aires, 1181, Argentina

Location

Investigational Site Number : 0320002

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320009

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320005

Buenos Aires, 1427, Argentina

Location

Investigational Site Number : 0360002

Kogarah, New South Wales, 2217, Australia

Location

Investigational Site Number : 0360001

Sydney, New South Wales, 2010, Australia

Location

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, 41820-020, Brazil

Location

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

Curitiba, Paraná, 80060-900, Brazil

Location

Pontifica Universidade Catolica do Parana- Site Number : 0760023

Curitiba, Paraná, 80215-901, Brazil

Location

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

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

Location

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo, 09060-650, Brazil

Location

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

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

Location

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, 18040-425, Brazil

Location

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

Rio de Janeiro, 22470-220, Brazil

Location

Investigational Site Number : 1240001

Calgary, Alberta, T2G 1B1, Canada

Location

Investigational Site Number : 1240051

Vancouver, British Columbia, V6t 2b5, Canada

Location

Investigational Site Number : 1240009

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Investigational Site Number : 1240008

Mississauga, Ontario, L5H 1G9, Canada

Location

Investigational Site Number : 1240011

Oakville, Ontario, L6J 7W5, Canada

Location

Investigational Site Number : 1240004

Peterborough, Ontario, K9J 5K2, Canada

Location

Investigational Site Number : 1240003

Richmond Hill, Ontario, L4B 1L1, Canada

Location

Investigational Site Number : 1240012

Toronto, Ontario, M3H 5Y8, Canada

Location

Investigational Site Number : 1240002

Montreal, Quebec, H3G 2S6, Canada

Location

Investigational Site Number : 1240010

Québec, Quebec, G1V 4X7, Canada

Location

Investigational Site Number : 1240006

Québec, Quebec, G1W 4R4, Canada

Location

Investigational Site Number : 1240044

Saskatoon, Saskatchewan, S7T 0G3, Canada

Location

Investigational Site Number : 1520009

Osorno, Los Lagos Region, 5311523, Chile

Location

Investigational Site Number : 1520004

Valdivia, Los Ríos Region, 5110683, Chile

Location

Investigational Site Number : 1520013

Lo Barnechea, Reg Metropolitana de Santiago, 7691236, Chile

Location

Investigational Site Number : 1520011

Santiago, Reg Metropolitana de Santiago, 7500505, Chile

Location

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, 7500588, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520010

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

Location

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 1520014

Chillan, 3800761, Chile

Location

Investigational Site Number : 1560015

Beijing, 100045, China

Location

Investigational Site Number : 1560008

Changchun, 130041, China

Location

Investigational Site Number : 1560016

Changsha, 410007, China

Location

Investigational Site Number : 1560014

Chengdu, 610017, China

Location

Investigational Site Number : 1560072

Fuzhou, 350001, China

Location

Investigational Site Number : 1560074

Guangzhou, 510120, China

Location

Investigational Site Number : 1560044

Hangzhou, 310003, China

Location

Investigational Site Number : 1560013

Jingzhou, 434020, China

Location

Investigational Site Number : 1560001

Shanghai, 200040, China

Location

Investigational Site Number : 1560018

Suzhou, 215006, China

Location

Investigational Site Number : 1560010

Taiyuan, 030001, China

Location

Investigational Site Number : 1560073

Taizhou, 318000, China

Location

Investigational Site Number : 1560019

Xinxiang, 453100, China

Location

Investigational Site Number : 1560012

Yinchuan, 750004, China

Location

Investigational Site Number : 1560011

Yiwu, 322000, China

Location

Investigational Site Number : 1560028

Zhenjiang, 212000, China

Location

Investigational Site Number : 2032105

Nový Jičín, 741 01, Czechia

Location

Investigational Site Number : 2032104

Ostrava, 702 00, Czechia

Location

Investigational Site Number : 2032102

Prague, 100 00, Czechia

Location

Investigational Site Number : 2030003

Prague, 100 34, Czechia

Location

Investigational Site Number : 2030006

Prague, 160 00, Czechia

Location

Investigational Site Number : 2030007

Prague, 180 81, Czechia

Location

Investigational Site Number : 2080001

Aarhus, 8200, Denmark

Location

Investigational Site Number : 2500004

Créteil, 94010, France

Location

Investigational Site Number : 2500001

Lille, 59037, France

Location

Investigational Site Number : 2500005

Marseille, 13885, France

Location

Investigational Site Number : 2500009

Nantes, 44093, France

Location

Investigational Site Number : 2500003

Paris, 75010, France

Location

Investigational Site Number : 2500006

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2500002

Toulouse, 31059, France

Location

Investigational Site Number : 2760020

Augsburg, 86150, Germany

Location

Investigational Site Number : 2760009

Bad Bentheim, 48455, Germany

Location

Investigational Site Number : 2762203

Berlin, 10117, Germany

Location

Investigational Site Number : 2762205

Dresden, 01307, Germany

Location

Investigational Site Number : 2762201

Münster, 48149, Germany

Location

Investigational Site Number : 2760010

Osnabrück, 49074, Germany

Location

Investigational Site Number : 2760021

Rostock, 18055, Germany

Location

Investigational Site Number : 2760019

Witten, 58453, Germany

Location

Investigational Site Number : 3560006

Bengaluru, 560004, India

Location

Investigational Site Number : 3560007

Bikaner, 334001, India

Location

Investigational Site Number : 3560011

Kochi, 682040, India

Location

Investigational Site Number : 3560005

Kolkata, 700073, India

Location

Investigational Site Number : 3560004

Mangaluru, 575002, India

Location

Investigational Site Number : 3560002

Nashik, 422101, India

Location

Investigational Site Number : 3560008

Surat, 395002, India

Location

Investigational Site Number : 3800003

Milan, Milano, 20122, Italy

Location

Investigational Site Number : 3800002

Naples, Napoli, 80131, Italy

Location

Investigational Site Number : 3800004

Naples, Napoli, 80138, Italy

Location

Investigational Site Number : 3800007

Rome, Roma, 00161, Italy

Location

Investigational Site Number : 3800006

Rome, Roma, 00168, Italy

Location

Investigational Site Number : 3800005

Brescia, 25123, Italy

Location

Investigational Site Number : 3800008

Vicenza, 36100, Italy

Location

Investigational Site Number : 3923114

Obihiro, Hokkaido, 080-0013, Japan

Location

Investigational Site Number : 3923113

Yokohama, Kanagawa, 221-0825, Japan

Location

Investigational Site Number : 3923110

Sakai, Osaka, 593-8324, Japan

Location

Investigational Site Number : 3923106

Mibu, Tochigi, 321-0293, Japan

Location

Investigational Site Number : 3920001

Tachikawa, Tokyo, 190-0023, Japan

Location

Investigational Site Number : 4840001

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840008

Durango, 34000, Mexico

Location

Investigational Site Number : 5280002

Breda, 4818 CK, Netherlands

Location

Investigational Site Number : 5280004

Rotterdam, 3015 CE, Netherlands

Location

Investigational Site Number : 5280001

Utrecht, 3584 CX, Netherlands

Location

Investigational Site Number : 6160012

Lublin, Lublin Voivodeship, 20-573, Poland

Location

Investigational Site Number : 6160014

Lodz, Lódzkie, 90-436, Poland

Location

Investigational Site Number : 6162411

Warsaw, Masovian Voivodeship, 01-142, Poland

Location

Investigational Site Number : 6160009

Warsaw, Masovian Voivodeship, 02-625, Poland

Location

Investigational Site Number : 6160007

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

Investigational Site Number : 6160006

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Investigational Site Number : 6160001

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

Investigational Site Number : 6160003

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Caribbean Medical Research Center- Site Number : 8400028

San Juan, 00918, Puerto Rico

Location

Investigational Site Number : 7100004

Boksburg, 1459, South Africa

Location

Investigational Site Number : 7100011

Cape Town, 7530, South Africa

Location

Investigational Site Number : 7100010

Cape Town, 7533, South Africa

Location

Investigational Site Number : 7100002

Cape Town, 7700, South Africa

Location

Investigational Site Number : 7100009

Cape Town, 7708, South Africa

Location

Investigational Site Number : 7100012

Durban, 3630, South Africa

Location

Investigational Site Number : 7100015

Durban, 4058, South Africa

Location

Investigational Site Number : 7100007

Johannesburg, 2196, South Africa

Location

Investigational Site Number : 7100006

Kempton Park, 1619, South Africa

Location

Investigational Site Number : 7100005

Middelburg, 1055, South Africa

Location

Investigational Site Number : 7100003

Pretoria, 0009, South Africa

Location

Investigational Site Number : 7100014

Pretoria, 0157, South Africa

Location

Investigational Site Number : 4100002

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

Location

Investigational Site Number : 4100016

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

Location

Investigational Site Number : 4100003

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Investigational Site Number : 4100018

Incheon, Incheon-gwangyeoksi, 21565, South Korea

Location

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, 05030, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 07441, South Korea

Location

Investigational Site Number : 7240002

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Investigational Site Number : 7240022

Sabadell, Barcelona [Barcelona], 08208, Spain

Location

Investigational Site Number : 7242505

Alicante, 03010, Spain

Location

Investigational Site Number : 7242501

Córdoba, 14004, Spain

Location

Investigational Site Number : 7242503

Madrid, 28046, Spain

Location

Investigational Site Number : 7240006

Valencia, 46026, Spain

Location

Investigational Site Number : 7560002

Buochs, 6374, Switzerland

Location

Investigational Site Number : 1580006

Hsinchu, 300, Taiwan

Location

Investigational Site Number : 1583201

Kaohsiung City, 833, Taiwan

Location

Investigational Site Number : 1580002

New Taipei City, 235, Taiwan

Location

Investigational Site Number : 1583202

Taichung, 402, Taiwan

Location

Investigational Site Number : 1580007

Taichung, 404, Taiwan

Location

Investigational Site Number : 1580001

Taipei, 100, Taiwan

Location

Investigational Site Number : 1583203

Taoyuan, 333, Taiwan

Location

Investigational Site Number : 7920005

Manisa, 45030, Turkey (Türkiye)

Location

Investigational Site Number : 8260001

London, England, NW3 2QG, United Kingdom

Location

Investigational Site Number : 8262601

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

Location

Investigational Site Number : 8260002

Edinburgh, EH8 9YL, United Kingdom

Location

Investigational Site Number : 8260004

Sheffield, S10 2TH, United Kingdom

Location

Related Links

• LTS17789 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): June 11, 2031
• Study Completion (Estimated): June 11, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); GB (4); CH (1); CZ (6); CN (16); CA (12); PR (1); NL (3); BR (9); CL (11); ZA (12); KR (6); DE (8); AR (10); IN (7); IT (7); PL (8); US (22); DK (1); JP (5); ME (2); FR (7); ES (6); TW (7); TU (1)