A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

NCT06130566 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: EFC17559U1111-1275-97152022-501196-41
• Study Type: interventional
• Target: 601
• Locations: 15 countries
• Sites: 148

Brief Summary

This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. 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 (37)

• 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

Amlitelimab dose 2

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab

Placebo

PLACEBO COMPARATOR

Subcutaneous injection as per protocol

Drug: Placebo

Interventions

Amlitelimab DRUG

Injection solution SC injection

Also known as: SAR445229

Amlitelimab dose 1; Amlitelimab dose 2

Placebo DRUG

Injection solution SC injection

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (148)

Scottsdale Clinical Trials- Site Number : 8401149

Scottsdale, Arizona, 85260, United States

Location

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, 94538, United States

Location

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, 94549, United States

Location

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

North Hollywood, California, 91606, United States

Location

Northridge Clinical Trials - Northridge- Site Number : 8401080

Northridge, California, 91325, United States

Location

St Jude Clinical Research- Site Number : 8401287

Doral, Florida, 33172, United States

Location

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

Fort Myers, Florida, 33919, United States

Location

Direct Helpers Research Center- Site Number : 8401056

Hialeah, Florida, 33012, United States

Location

Encore Medical Research- Site Number : 8401030

Hollywood, Florida, 33021, United States

Location

Florida International Research Center- Site Number : 8401091

Miami, Florida, 33173, United States

Location

Miami Dermatology and Laser Research- Site Number : 8401086

Miami, Florida, 33173, United States

Location

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

Orlando, Florida, 32806, United States

Location

Cleaver Medical Group Dermatology- Site Number : 8401139

Cumming, Georgia, 30040, United States

Location

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

Macon, Georgia, 31217, United States

Location

Javara Research - Thomasville- Site Number : 8401189

Thomasville, Georgia, 31792, United States

Location

Rophe Adult & Pediatric Medicine- Site Number : 8401289

Union City, Georgia, 30291, United States

Location

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, 40217, United States

Location

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, 70433, United States

Location

MedPharmics - Lafeyette- Site Number : 8401152

Lafayette, Louisiana, 70508, United States

Location

Massachusetts General Hospital- Site Number : 8401192

Boston, Massachusetts, 02114, United States

Location

Metro Boston Clinical Partners- Site Number : 8401128

Needham, Massachusetts, 02492, United States

Location

Revival Research - Doral- Site Number : 8401012

Dearborn, Michigan, 33122, United States

Location

Henry Ford Hospital- Site Number : 8401044

Detroit, Michigan, 48202, United States

Location

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

Ridgeland, Mississippi, 39157, United States

Location

MediSearch Clinical Trials- Site Number : 8401140

Saint Joseph, Missouri, 64506, United States

Location

Somnos Clinical Research- Site Number : 8401203

Lincoln, Nebraska, 68510, United States

Location

Universal Dermatology- Site Number : 8401224

Fairport, New York, 14450, United States

Location

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

New York, New York, 10075, United States

Location

CHEAR Center- Site Number : 8401123

The Bronx, New York, 10459, United States

Location

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

Charlotte, North Carolina, 28277, United States

Location

Oregon Medical Research Center- Site Number : 8401017

Portland, Oregon, 97201, United States

Location

Vial Health - DermDox Dermatology- Site Number : 8401031

Camp Hill, Pennsylvania, 17011, United States

Location

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, 19114, United States

Location

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

Greenville, South Carolina, 29607, United States

Location

Dermatology Treatment and Research Center- Site Number : 8401164

Dallas, Texas, 75230, United States

Location

Skin Specialist of Addison- Site Number : 8401208

Dallas, Texas, 75254, United States

Location

Texas Dermatology and Laser Specialists- Site Number : 8401131

San Antonio, Texas, 78218, United States

Location

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, 76092, United States

Location

Springville Dermatology - Springville- Site Number : 8401106

Springville, Utah, 84663, United States

Location

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, 23502, United States

Location

Investigational Site Number : 0320023

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

Location

Investigational Site Number : 0320024

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

Location

Investigational Site Number : 0320022

Buenos Aires, 1012, Argentina

Location

Investigational Site Number : 0320010

Buenos Aires, 1414, Argentina

Location

Investigational Site Number : 0360010

Westmead, New South Wales, 2145, Australia

Location

Investigational Site Number : 0360007

Woolloongabba, Queensland, 4102, Australia

Location

Investigational Site Number : 0360008

Melbourne, Victoria, 3002, Australia

Location

Investigational Site Number : 0360006

Melbourne, Victoria, 3004, Australia

Location

Investigational Site Number : 0361006

Traralgon, Victoria, 3844, Australia

Location

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, 41820-020, Brazil

Location

Hospital São Domingos- Site Number : 0760028

Bequimão, Maranhão, 65060-645, Brazil

Location

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

Curitiba, Paraná, 80060-900, 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

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, 18040-425, Brazil

Location

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

Rio de Janeiro, 22241-180, Brazil

Location

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, 09060-650, Brazil

Location

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

São Paulo, 04020-060, Brazil

Location

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

São Paulo, 05403-000, Brazil

Location

Investigational Site Number : 1240031

Edmonton, Alberta, T5K 2V4, Canada

Location

Investigational Site Number : 1240040

Surrey, British Columbia, V3R 6A7, Canada

Location

Investigational Site Number : 1240033

Ajax, Ontario, L1S 7K8, Canada

Location

Investigational Site Number : 1240055

Hamilton, Ontario, L8S 1G5, Canada

Location

Investigational Site Number : 1240029

London, Ontario, N6A 2C2, Canada

Location

Investigational Site Number : 1241108

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Investigational Site Number : 1240034

Ottawa, Ontario, K1H 7X8, Canada

Location

Investigational Site Number : 1240013

Toronto, Ontario, M3B 3N1, Canada

Location

Investigational Site Number : 1240035

Toronto, Ontario, M5A 3R6, Canada

Location

Investigational Site Number : 1240043

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Investigational Site Number : 1240028

Regina, Saskatchewan, S4V 1R9, Canada

Location

Investigational Site Number : 1240036

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Investigational Site Number : 1520009

Osorno, Reg Metropolitana de Santiago, 5311523, Chile

Location

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, 7500587, 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 : 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 : 1520012

Talcahuano, 2687000, Chile

Location

Investigational Site Number : 1560042

Beijing, 100034, China

Location

Investigational Site Number : 1560060

Chengdu, 610072, China

Location

Investigational Site Number : 1560068

Chengdu, 610091, China

Location

Investigational Site Number : 1560057

Chongqing, 400016, China

Location

Investigational Site Number : 1560065

Chongqing, 400065, China

Location

Investigational Site Number : 1560058

Guangzhou, 510630, China

Location

Investigational Site Number : 1560059

Jinan, 250014, China

Location

Investigational Site Number : 1560064

Shenzhen, 518026, China

Location

Investigational Site Number : 2500008

Antony, 92160, France

Location

Investigational Site Number : 2500009

Nantes, 44093, France

Location

Investigational Site Number : 2500003

Paris, 75010, France

Location

Investigational Site Number : 2500007

Reims, 51100, France

Location

Investigational Site Number : 2500010

Romans-sur-Isère, 26102, France

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 : 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 : 3000004

Athens, 124 62, Greece

Location

Investigational Site Number : 3000001

Athens, 161 21, Greece

Location

Investigational Site Number : 3000002

Thessaloniki, 546 42, Greece

Location

Investigational Site Number : 3000003

Thessaloniki, 564 29, Greece

Location

Investigational Site Number : 3560001

Ahmedabad, 380016, India

Location

Investigational Site Number : 3560005

Belagavi, 590002, India

Location

Investigational Site Number : 3560008

Bengaluru, 560090, India

Location

Investigational Site Number : 3560004

Chandigarh, 160012, India

Location

Investigational Site Number : 3560006

Haryāna, 121002, India

Location

Investigational Site Number : 3560007

Kolkata, 700073, India

Location

Investigational Site Number : 3560002

Nagpur, 440015, India

Location

Investigational Site Number : 3560003

Pune, 411057, India

Location

Investigational Site Number : 3760004

Afula, 1834111, Israel

Location

Investigational Site Number : 3760005

Beersheba, 8457108, Israel

Location

Investigational Site Number : 3760001

Haifa, 3109601, Israel

Location

Investigational Site Number : 3760003

Jerusalem, 9112001, Israel

Location

Investigational Site Number : 3760006

Petah Tikva, 4920235, Israel

Location

Investigational Site Number : 3760002

Petah Tikva, 4941492, Israel

Location

Investigational Site Number : 6160006

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Investigational Site Number : 6160003

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Investigational Site Number : 6162406

Krakow, 31-209, Poland

Location

Investigational Site Number : 6160002

Lodz, 90-265, Poland

Location

Investigational Site Number : 6160004

Lublin, 20-607, Poland

Location

Investigational Site Number : 6160011

Olsztyn, 11-041, Poland

Location

Investigational Site Number : 6160010

Tarnów, 33-100, Poland

Location

Investigational Site Number : 6160009

Warsaw, 02-625, Poland

Location

Investigational Site Number : 6160007

Warsaw, 02-962, Poland

Location

Investigational Site Number : 4100008

Daegu, Daegu, 41944, South Korea

Location

Investigational Site Number : 4100002

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

Location

Investigational Site Number : 4100014

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

Location

Investigational Site Number : 4100009

Suwon, Gyeonggi-do, 16499, South Korea

Location

Investigational Site Number : 4100003

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Investigational Site Number : 4100015

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

Location

Investigational Site Number : 4100010

Seoul, Seoul-teukbyeolsi, 01812, South Korea

Location

Investigational Site Number : 4100013

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 4100007

Seoul, Seoul-teukbyeolsi, 03722, South Korea

Location

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, 05030, South Korea

Location

Investigational Site Number : 4100011

Seoul, Seoul-teukbyeolsi, 06591, South Korea

Location

Investigational Site Number : 4100017

Seoul, Seoul-teukbyeolsi, 07804, South Korea

Location

Investigational Site Number : 4100012

Gwangju, 61453, South Korea

Location

Investigational Site Number : 1583201

Kaohsiung City, 833, Taiwan

Location

Investigational Site Number : 1583202

Taichung, 402, Taiwan

Location

Investigational Site Number : 1580001

Taipei, 100, Taiwan

Location

Investigational Site Number : 1580003

Taipei, Taiwan

Location

Investigational Site Number : 1583203

Taoyuan, 333, Taiwan

Location

Related Links

• EFC17559 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 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: November 8, 2023
• First Posted: November 14, 2023
• Study Start: November 8, 2023
• Primary Completion: July 23, 2025
• Study Completion: November 13, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

GR (4); US (42); IN (8); AR (4); IL (6); KR (13); BR (10); CA (12); TW (5); FR (5); DE (7); PL (9); CL (10); CN (8); AU (5)