A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

NCT06224348 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: EFC175612023-506558-20U1111-1275-9760
• Study Type: interventional
• Target: 643
• Locations: 14 countries
• Sites: 167

Brief Summary

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (3)

• EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

  The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

  Week 24

• EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24

  The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  Week 24

• US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

  The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

  Week 24

Secondary Outcomes (39)

• Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)

  Week 24

• Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) and a reduction from baseline of ≥2 points

  Baseline to Week 24

• Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4

  Baseline to Week 24

• Proportion of participants reaching EASI-75

  Baseline to Week 20

• Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points

  Baseline to Week 20

Study Arms (3)

Amlitelimab dose 1

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors

Amlitelimab dose 2

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors

Placebo

PLACEBO COMPARATOR

Subcutaneous injection as per protocol

Drug: Placebo; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors

Interventions

Amlitelimab DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Also known as: SAR445229

Amlitelimab dose 1; Amlitelimab dose 2

Placebo DRUG

Pharmaceutical form: injection solution Route of administration: SC injection

Placebo

Topical corticosteroids DRUG

Pharmaceutical form: Topical formulation Route of administration: Topical

Amlitelimab dose 1; Amlitelimab dose 2; Placebo

Topical calcineurin inhibitors DRUG

Pharmaceutical form: Topical formulation Route of administration: Topical

Amlitelimab dose 1; Amlitelimab dose 2; Placebo

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (167)

Cahaba Dermatology & Skin Health Center- Site Number : 8401066

Birmingham, Alabama, 35244, United States

Location

Johnson Dermatology- Site Number : 8401076

Fort Smith, Arkansas, 72916, United States

Location

Encino Research Center- Site Number : 8401042

Encino, California, 91436, United States

Location

Marvel Clinical Research- Site Number : 8401102

Huntington Beach, California, 92647, United States

Location

LA Universal Research Center- Site Number : 8401064

Los Angeles, California, 90057, United States

Location

Cura Clinical Research- Site Number : 8401141

Palmdale, California, 93551, United States

Location

Integrative Skin Science and Research- Site Number : 8401275

Sacramento, California, 95815, United States

Location

Southern California Dermatology- Site Number : 8401043

Santa Ana, California, 92701, United States

Location

Skin Care Research - Hollywood- Site Number : 8401071

Hollywood, Florida, 33021, United States

Location

Clever Medical Research- Site Number : 8401160

Miami, Florida, 33126, United States

Location

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, 33142, United States

Location

Palm Springs Community Health Center- Site Number : 8401264

Miami Lakes, Florida, 33016, United States

Location

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, 33705, United States

Location

University of South Florida- Site Number : 8401070

Tampa, Florida, 33612, United States

Location

Avita Clinical Research- Site Number : 8401073

Tampa, Florida, 33613, United States

Location

Cleaver Medical Group- Site Number : 8401138

Dawsonville, Georgia, 30534, United States

Location

NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038

Skokie, Illinois, 60076, United States

Location

Dawes Fretzin Clinical Research- Site Number : 8401015

Indianapolis, Indiana, 46256, United States

Location

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, 70053, United States

Location

Velocity Clinical Research - New Orleans- Site Number : 8401155

New Orleans, Louisiana, 70119, United States

Location

Oakland Medical Center- Site Number : 8401116

Troy, Michigan, 48085, United States

Location

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

Ypsilanti, Michigan, 48197, United States

Location

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

Lee's Summit, Missouri, 64064, United States

Location

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, 68144, United States

Location

Jubilee Clinical Research- Site Number : 8401054

Las Vegas, Nevada, 89106, United States

Location

Allcutis Research - Portsmouth- Site Number : 8401082

Portsmouth, New Hampshire, 03801, United States

Location

Equity Medical- Site Number : 8401239

New York, New York, 10023, United States

Location

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

New York, New York, 10029, United States

Location

OptiSkin- Site Number : 8401163

New York, New York, 10128, United States

Location

Apex Clinical Research Center- Site Number : 8401237

Mayfield Heights, Ohio, 44124, United States

Location

Essential Medical Research- Site Number : 8401183

Tulsa, Oklahoma, 74137, United States

Location

Vial Health - DermDox Dermatology- Site Number : 8401031

Camp Hill, Pennsylvania, 17011, United States

Location

Clinical Research Center of the Carolinas- Site Number : 8401067

Charleston, South Carolina, 29407, United States

Location

SMS Clinical Research- Site Number : 8401182

Mesquite, Texas, 75149, United States

Location

Sienna Dermatology- Site Number : 8401148

Missouri City, Texas, 77459, United States

Location

Texas Dermatology and Laser Specialists- Site Number : 8401131

San Antonio, Texas, 78218, United States

Location

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

San Antonio, Texas, 78258, United States

Location

Complete Dermatology - Sugar Land- Site Number : 8401061

Sugar Land, Texas, 77479, United States

Location

Cope Family Medicine - Ogden Clinic- Site Number : 8401114

Bountiful, Utah, 84010, United States

Location

Tanner Clinic - Layton Antelope A- Site Number : 8401151

Layton, Utah, 84041, United States

Location

Investigational Site Number : 0320005

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

Location

Investigational Site Number : 0320011

Buenos Aires, 1035, Argentina

Location

Investigational Site Number : 0320019

Buenos Aires, 1056, Argentina

Location

Investigational Site Number : 0320008

Buenos Aires, 1061, Argentina

Location

Investigational Site Number : 0320018

Buenos Aires, 1178, Argentina

Location

Investigational Site Number : 0320010

Buenos Aires, 1414, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320012

Corrientes, 3400, Argentina

Location

Investigational Site Number : 0320013

Mendoza, 5500, Argentina

Location

Investigational Site Number : 0320020

San Miguel de Tucumán, 4000, Argentina

Location

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

Vitória, Espírito Santo, 29055-450, Brazil

Location

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, 41820-020, Brazil

Location

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

Curitiba, Paraná, 80230-130, 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 São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024

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

Location

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, 09060-650, Brazil

Location

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

São Paulo, 01323-020, Brazil

Location

Hospital das Clinicas FMUSP- Site Number : 0760012

São Paulo, 05403-000, Brazil

Location

Investigational Site Number : 1002007

Dupnitsa, 2600, Bulgaria

Location

Investigational Site Number : 1002004

Pleven, 5800, Bulgaria

Location

Investigational Site Number : 1002009

Sofia, 1431, Bulgaria

Location

Investigational Site Number : 1002006

Sofia, 1592, Bulgaria

Location

Investigational Site Number : 1240039

Calgary, Alberta, T2J 7E1, Canada

Location

Investigational Site Number : 1240045

Red Deer, Alberta, T4P 1K4, Canada

Location

Investigational Site Number : 1240046

Kamloops, British Columbia, V1Y 4N7, Canada

Location

Investigational Site Number : 1240030

Surrey, British Columbia, V3V 0C6, Canada

Location

Investigational Site Number : 1240041

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigational Site Number : 1240057

Brampton, Ontario, L6Z1Y4, Canada

Location

Investigational Site Number : 1241106

Markham, Ontario, L3P 1X2, Canada

Location

Investigational Site Number : 1240008

Mississauga, Ontario, L5H 1G9, Canada

Location

Investigational Site Number : 1240004

Peterborough, Ontario, K9J5K2, Canada

Location

Investigational Site Number : 1240038

Richmond Hill, Ontario, L4E 4L6, Canada

Location

Investigational Site Number : 1240012

Toronto, Ontario, M3H 5Y8, Canada

Location

Investigational Site Number : 1241107

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigational Site Number : 1240006

Québec, Quebec, G1W 4R4, Canada

Location

Investigational Site Number : 1520009

Osorno, Reg Metropolitana de Santiago, 5311523, 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 : 1520011

Santiago, Reg Metropolitana de Santiago, 8380456, 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 : 1520006

Viña del Mar, Región de Valparaíso, 2530900, Chile

Location

Investigational Site Number : 1520010

Santiago, 8330032, Chile

Location

Investigational Site Number : 1520012

Talcahuano, 2687000, Chile

Location

Investigational Site Number : 1560050

Changsha, 410011, China

Location

Investigational Site Number : 1560060

Chengdu, 610072, China

Location

Investigational Site Number : 1560043

Fuzhou, 350005, China

Location

Investigational Site Number : 1560021

Guangzhou, 510018, China

Location

Investigational Site Number : 1560044

Hangzhou, 310003, China

Location

Investigational Site Number : 1560006

Hangzhou, 310009, China

Location

Investigational Site Number : 1560051

Nanchang, 330001, China

Location

Investigational Site Number : 1560005

Shanghai, 200443, China

Location

Investigational Site Number : 1560041

Shenyang, 110001, China

Location

Investigational Site Number : 1560047

Tianjin, 300052, China

Location

Investigational Site Number : 1560049

Wuhan, 430022, China

Location

Investigational Site Number : 1560003

Wuxi, 214000, China

Location

Investigational Site Number : 2032105

Nový Jičín, 741 01, Czechia

Location

Investigational Site Number : 2030010

Olomouc, 779 00, Czechia

Location

Investigational Site Number : 2032104

Ostrava, 702 00, Czechia

Location

Investigational Site Number : 2030009

Pilsen, 323 00, Czechia

Location

Investigational Site Number : 2030008

Prague, 110 00, Czechia

Location

Investigational Site Number : 2030008

Prague, 110 01, Czechia

Location

Investigational Site Number : 2030011

Prague, 150 00, Czechia

Location

Investigational Site Number : 2500011

Bordeaux, 33000, France

Location

Investigational Site Number : 2500009

Nantes, 44093, France

Location

Investigational Site Number : 2500013

Nice, 06202, France

Location

Investigational Site Number : 2500006

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2500010

Romans-sur-Isère, 26102, France

Location

Investigational Site Number : 2500012

Rouen, 76031, France

Location

Investigational Site Number : 2500016

Saint-Pierre, 97410, 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 : 2760014

Buxtehude, 21614, Germany

Location

Investigational Site Number : 2760017

Hamburg, 20095, Germany

Location

Investigational Site Number : 2760021

Hamburg, 20354, Germany

Location

Investigational Site Number : 2762208

Kiel, 24105, Germany

Location

Investigational Site Number : 2760018

Magdeburg, 39104, Germany

Location

Investigational Site Number : 2760016

Mainz, 55128, Germany

Location

Investigational Site Number : 2762201

Münster, 48149, Germany

Location

Investigational Site Number : 2760019

Witten, 58453, Germany

Location

Investigational Site Number : 3800003

Milan, Lombardy, 20122, Italy

Location

Investigational Site Number : 3800012

Bologna, 40138, Italy

Location

Investigational Site Number : 3800011

L’Aquila, 67100, Italy

Location

Investigational Site Number : 3800008

Pisa, 56126, Italy

Location

Investigational Site Number : 3800019

Torette, 60020, Italy

Location

Investigational Site Number : 3920009

Chitose, Hokkaido, 066-0021, Japan

Location

Investigational Site Number : 3923114

Obihiro, Hokkaido, 080-0013, Japan

Location

Investigational Site Number : 3920008

Sapporo, Hokkaido, 064-0921, Japan

Location

Investigational Site Number : 3920006

Kobe, Hyōgo, 653-0836, Japan

Location

Investigational Site Number : 3920005

Sagamihara, Kanagawa, 252-0315, Japan

Location

Investigational Site Number : 3923113

Yokohama, Kanagawa, 221-0825, Japan

Location

Investigational Site Number : 3920010

Miyagi-gun, Miyagi, 981-0112, Japan

Location

Investigational Site Number : 3920011

Sendai, Miyagi, 981-3133, Japan

Location

Investigational Site Number : 3923110

Sakai, Osaka, 593-8324, Japan

Location

Investigational Site Number : 3920002

Iruma, Saitama, 350-0495, Japan

Location

Investigational Site Number : 3923106

Mibu, Tochigi, 321-0293, Japan

Location

Investigational Site Number : 3920004

Chūō, Tokyo, 104-0031, Japan

Location

Investigational Site Number : 3923107

Minato, Tokyo, 108-0014, Japan

Location

Investigational Site Number : 3920001

Tachikawa, Tokyo, 190-0023, Japan

Location

Investigational Site Number : 3923109

Habikino, 583-8588, Japan

Location

Investigational Site Number : 3923108

Kagoshima, 890-0063, Japan

Location

Investigational Site Number : 3923102

Kyoto, 602-8566, Japan

Location

Investigational Site Number : 3920003

Kyoto, 606-8507, Japan

Location

Investigational Site Number : 3923113

Yokohama, 221-0825, Japan

Location

Investigational Site Number : 7240019

Granada, Andalusia, 18012, Spain

Location

Investigational Site Number : 7240020

Seville, Andalusia, 41013, Spain

Location

Investigational Site Number : 7240008

Bilbao, Bizkaia, 48013, Spain

Location

Investigational Site Number : 7240010

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

Location

Investigational Site Number : 7240015

Pamplona, Navarre, 31008, Spain

Location

Investigational Site Number : 7242502

Manises, Valencia, 46940, Spain

Location

Investigational Site Number : 7240023

Burjassot, Valenciana, Comunidad, 46100, Spain

Location

Investigational Site Number : 7242505

Alicante, 03010, Spain

Location

Investigational Site Number : 7240013

Madrid, 28031, Spain

Location

Investigational Site Number : 7240014

Vigo, 36206, Spain

Location

Investigational Site Number : 7920010

Ankara, 06560, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Antalya, 07070, Turkey (Türkiye)

Location

Investigational Site Number : 7920008

Gaziantep, 27310, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Istanbul, 34010, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Istanbul, 34093, Turkey (Türkiye)

Location

Investigational Site Number : 7920006

Istanbul, 34093, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number : 7920009

Istanbul, 34662, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 7920007

Samsun, 55139, Turkey (Türkiye)

Location

Related Links

• EFC17561 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Adrenal Cortex Hormones; Calcineurin Inhibitors

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: January 18, 2024
• Primary Completion: August 21, 2025
• Study Completion: November 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (10); CA (13); US (40); CZ (7); ES (10); BU (4); FR (8); DE (10); AR (10); JP (19); IT (5); CL (10); CN (12); BR (9)