A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

NCT06241118 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC175992023-508099-12U1111-1295-3059
• Study Type: interventional
• Target: 390
• Locations: 23 countries
• Sites: 146

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 AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. 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 have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).

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 36

  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 36

• EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36

  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 36

• 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 36

  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 36

Secondary Outcomes (41)

• Proportion of participants reaching EASI-75 at Week 36 (for US and US reference countries only)

  Week 36

• 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 36

• 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 36

• Proportion of participants reaching EASI-75

  Baseline to Week 24

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

  Baseline to Week 24

Study Arms (3)

Amlitelimab dose 1

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical tacrolimus or pimecrolimus

Amlitelimab dose 2

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical tacrolimus or pimecrolimus

Placebo

PLACEBO COMPARATOR

Subcutaneous injection as per protocol

Drug: Placebo; Drug: Topical corticosteroids; Drug: Topical tacrolimus or pimecrolimus

Interventions

Topical corticosteroids DRUG

Pharmaceutical form: Various Topical formulation Route of administration: Topical

Amlitelimab dose 1; Amlitelimab dose 2; Placebo

Topical tacrolimus or pimecrolimus DRUG

Pharmaceutical form: Various Topical formulation Route of administration: Topical

Amlitelimab dose 1; Amlitelimab dose 2; Placebo

Amlitelimab DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Also known as: SAR445229

Amlitelimab dose 1; Amlitelimab dose 2

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
• 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 (146)

University of Alabama at Birmingham- Site Number : 8401267

Birmingham, Alabama, 35233, United States

RECRUITING

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, 85260, United States

RECRUITING

Arkansas Dermatology - North Little Rock- Site Number : 8401244

North Little Rock, Arkansas, 72117, United States

RECRUITING

Encino Research Center- Site Number : 8401042

Encino, California, 91436, United States

RECRUITING

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, 94538, United States

RECRUITING

Long Beach Clinical Trials- Site Number : 8401188

Long Beach, California, 90806, United States

RECRUITING

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California, 90045, United States

RECRUITING

LA Universal Research Center- Site Number : 8401064

Los Angeles, California, 90057, United States

RECRUITING

University Dermatology Trials- Site Number : 8401339

Newport Beach, California, 92660, United States

RECRUITING

Rady Children's Hospital- Site Number : 8401291

San Diego, California, 92123, United States

RECRUITING

Therapeutics Clinical Research- Site Number : 8401283

San Diego, California, 92123, United States

RECRUITING

Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

Wheat Ridge, Colorado, 80033, United States

RECRUITING

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida, 33436, United States

RECRUITING

St. Jude Clinical Research- Site Number : 8401287

Doral, Florida, 33172, United States

RECRUITING

Apex Clinical Research - Jacksonville- Site Number : 8401332

Jacksonville, Florida, 32256, United States

RECRUITING

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, 33705, United States

RECRUITING

Avita Clinical Research- Site Number : 8401073

Tampa, Florida, 33613, United States

RECRUITING

Northwestern University- Site Number : 8401285

Chicago, Illinois, 60611, United States

RECRUITING

NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038

Skokie, Illinois, 60077, United States

RECRUITING

Dawes Fretzin Clinical Research- Site Number : 8401015

Indianapolis, Indiana, 46256, United States

RECRUITING

Equity Medical - Bowling Green- Site Number : 8401296

Bowling Green, Kentucky, 42104, United States

RECRUITING

Tandem Clinical Research - Metairie- Site Number : 8401187

Metairie, Louisiana, 70006, United States

RECRUITING

University of Michigan Health System - Ann Arbor- Site Number : 8401290

Ann Arbor, Michigan, 48109, United States

RECRUITING

MI Skin Center- Site Number : 8401307

Northville, Michigan, 48167, United States

RECRUITING

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, 68144, United States

RECRUITING

Schweiger Dermatology Group - East Windsor- Site Number : 8401338

East Windsor, New Jersey, 08520, United States

RECRUITING

The University of New Mexico- Site Number : 8401263

Albuquerque, New Mexico, 87106, United States

RECRUITING

Equity Medical- Site Number : 8401239

New York, New York, 10023, United States

RECRUITING

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

New York, New York, 10075, United States

RECRUITING

Cincinnati Children's Hospital Medical Center- Site Number : 8401279

Cincinnati, Ohio, 45229, United States

RECRUITING

Oregon Health & Science University (OHSU)- Site Number : 8401247

Portland, Oregon, 97239, United States

RECRUITING

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, 19114, United States

RECRUITING

Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282

Charleston, South Carolina, 29425, United States

RECRUITING

Arlington Research Center- Site Number : 8401248

Arlington, Texas, 76011, United States

RECRUITING

McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288

Bellaire, Texas, 77401, United States

RECRUITING

Reveal Research Institute - Dallas- Site Number : 8401219

Dallas, Texas, 75235, United States

RECRUITING

Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057

Ogden, Utah, 84405, United States

RECRUITING

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, 23502, United States

RECRUITING

North Sound Dermatology- Site Number : 8401280

Mill Creek, Washington, 98012, United States

RECRUITING

Children's Wisconsin- Site Number : 8401246

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Cheyenne Skin Clinic- Site Number : 8401234

Cheyenne, Wyoming, 82009, United States

RECRUITING

Investigational Site Number : 0320007

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Investigational Site Number : 0320011

Buenos Aires, 1035, Argentina

RECRUITING

Investigational Site Number : 0320019

Buenos Aires, 1426, Argentina

RECRUITING

Investigational Site Number : 0320014

Córdoba, 5000, Argentina

RECRUITING

Investigational Site Number : 0360008

Melbourne, Victoria, 3002, Australia

RECRUITING

Investigational Site Number : 0360006

Melbourne, Victoria, 3004, Australia

RECRUITING

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, 41820-020, Brazil

RECRUITING

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

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

RECRUITING

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo, 09060-650, Brazil

RECRUITING

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, 18040-425, Brazil

COMPLETED

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

São Paulo, 01323-020, Brazil

RECRUITING

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

São Paulo, 04020-060, Brazil

RECRUITING

Investigational Site Number : 1240019

Calgary, Alberta, T2W 4X9, Canada

RECRUITING

Investigational Site Number : 1240016

Edmonton, Alberta, T5J 3S9, Canada

RECRUITING

Investigational Site Number : 1240058

Burlington, Ontario, L7L 6W6, Canada

RECRUITING

Investigational Site Number : 1240020

Hamilton, Ontario, L8L 3C3, Canada

RECRUITING

Investigational Site Number : 1240053

London, Ontario, N6A 5R9, Canada

RECRUITING

Investigational Site Number : 1240054

Toronto, Ontario, M5M 3Z8, Canada

RECRUITING

Investigational Site Number : 1240028

Regina, Saskatchewan, S4V 1R9, Canada

RECRUITING

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

RECRUITING

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

RECRUITING

Investigational Site Number : 1520010

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

RECRUITING

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

RECRUITING

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

RECRUITING

Investigational Site Number : 1560031

Changchun, 130021, China

RECRUITING

Investigational Site Number : 1560021

Guangzhou, 510018, China

RECRUITING

Investigational Site Number : 1560036

Guangzhou, 510100, China

RECRUITING

Investigational Site Number : 1560044

Hangzhou, 310003, China

RECRUITING

Investigational Site Number : 1560002

Hangzhou, 310006, China

RECRUITING

Investigational Site Number : 1560009

Hangzhou, 310009, China

RECRUITING

Investigational Site Number : 1560034

Nanyang, 473014, China

RECRUITING

Investigational Site Number : 1560024

Ningbo, 315010, China

RECRUITING

Investigational Site Number : 1560035

Ningbo, 315010, China

RECRUITING

Investigational Site Number : 1560001

Shanghai, 200040, China

RECRUITING

Investigational Site Number : 1560041

Shenyang, 110001, China

RECRUITING

Investigational Site Number : 1560038

Wuhan, 430030, China

RECRUITING

Investigational Site Number : 1560032

Xi'an, 710004, China

RECRUITING

Investigational Site Number : 2500011

Bordeaux, 33000, France

RECRUITING

Investigational Site Number : 2500014

Clermont-Ferrand, 63100, France

ACTIVE NOT RECRUITING

Investigational Site Number : 2500004

Créteil, 94010, France

RECRUITING

Investigational Site Number : 2500001

Lille, 59037, France

RECRUITING

Investigational Site Number : 2500017

Paris, 75010, France

RECRUITING

Investigational Site Number : 2500012

Rouen, 76031, France

RECRUITING

Investigational Site Number : 2762203

Berlin, 10117, Germany

RECRUITING

Investigational Site Number : 2762202

Blankenfelde-Mahlow, 15831, Germany

RECRUITING

Investigational Site Number : 2761001

Dresden, 01307, Germany

RECRUITING

Investigational Site Number : 2760022

Frankfurt, 60590, Germany

RECRUITING

Investigational Site Number : 2761002

Lübeck, 23538, Germany

RECRUITING

Investigational Site Number : 2760019

Witten, 58453, Germany

RECRUITING

Investigational Site Number : 3000004

Athens, 124 62, Greece

RECRUITING

Investigational Site Number : 3000001

Athens, 161 21, Greece

RECRUITING

Investigational Site Number : 3000005

Athens, 161 21, Greece

RECRUITING

Investigational Site Number : 3000002

Thessaloniki, 546 43, Greece

RECRUITING

Investigational Site Number : 3760005

Beersheba, 8457108, Israel

RECRUITING

Investigational Site Number : 3760008

Ramat Gan, 5262100, Israel

RECRUITING

Investigational Site Number : 3760007

Tel Aviv, 6423906, Israel

RECRUITING

Investigational Site Number : 3800020

Turin, Torino, 10126, Italy

RECRUITING

Center for Advanced Studies and Technology-Site Number: 3800016

Chieti, 66100, Italy

RECRUITING

A.O.U. di Modena -Site Number: 3800021

Modena, 41125, Italy

RECRUITING

UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"-Site Number : 3800017

Naples, 80131, Italy

RECRUITING

Azienda ospedaliera di Perugia - Ospedale "Santa Maria della Misericordia"-Site Number: 3800015

Perugia, 06129, Italy

RECRUITING

Investigational Site Number : 3923113

Yokohama, Kanagawa, 221-0825, Japan

RECRUITING

Investigational Site Number : 3923109

Habikino, Osaka, 583-8588, Japan

RECRUITING

Investigational Site Number : 3923110

Sakai, Osaka, 593-8324, Japan

RECRUITING

Investigational Site Number : 3923106

Mibu, Tochigi, 321-0293, Japan

RECRUITING

Investigational Site Number : 3920001

Tachikawa, Tokyo, 190-0023, Japan

RECRUITING

Investigational Site Number : 3920007

Hiroshima, 734-8551, Japan

RECRUITING

Investigational Site Number : 4840011

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Investigational Site Number : 4840003

Veracruz, 91900, Mexico

RECRUITING

Investigational Site Number : 6162417

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

RECRUITING

Investigational Site Number : 6160002

Lublin, Lublin Voivodeship, 20-363, Poland

RECRUITING

Investigational Site Number : 6162411

Warsaw, Masovian Voivodeship, 01-142, Poland

RECRUITING

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 02-507, Poland

RECRUITING

Investigational Site Number : 6160006

Gdansk, Pomeranian Voivodeship, 80-546, Poland

RECRUITING

Investigational Site Number : 2500016

Saint-Pierre, 97448, Reunion

RECRUITING

Investigational Site Number : 6820001

Riyadh, 12713, Saudi Arabia

RECRUITING

Investigational Site Number : 4100002

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

RECRUITING

Investigational Site Number : 4100014

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

RECRUITING

Investigational Site Number : 4100015

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

RECRUITING

Investigational Site Number : 4100007

Seoul, Seoul-teukbyeolsi, 03722, South Korea

RECRUITING

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 07441, South Korea

RECRUITING

Investigational Site Number : 7240002

Badalona, Barcelona [Barcelona], 08916, Spain

RECRUITING

Investigational Site Number : 7240017

Majadahonda, Madrid, 28222, Spain

RECRUITING

Investigational Site Number : 7240020

Seville, Sevilla, 41013, Spain

RECRUITING

Investigational Site Number : 7242505

Alicante, 03010, Spain

RECRUITING

Investigational Site Number : 7242503

Madrid, 28046, Spain

RECRUITING

Investigational Site Number : 1583201

Kaohsiung City, 833, Taiwan

ACTIVE NOT RECRUITING

Investigational Site Number : 1580001

Taipei, 100, Taiwan

RECRUITING

Investigational Site Number : 1580003

Taipei, Taiwan

RECRUITING

Investigational Site Number : 1583203

Taoyuan, 333, Taiwan

RECRUITING

Investigational Site Number : 7920008

Gaziantep, 27310, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920005

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920002

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7841002

Abu Dhabi, 51900, United Arab Emirates

RECRUITING

Investigational Site Number : 7840001

Abu Dhabi, 6222, United Arab Emirates

RECRUITING

Investigational Site Number : 7840002

Abu Dhabi, United Arab Emirates

RECRUITING

Investigational Site Number : 8260013

Bristol, Bristol, City of, BS2 8HW, United Kingdom

RECRUITING

Investigational Site Number : 8260012

Plymouth, Devon, PL6 8DH, United Kingdom

RECRUITING

Investigational Site Number : 8262603

London, England, E11 1NR, United Kingdom

RECRUITING

Investigational Site Number : 8260015

London, England, SW10 9NH, United Kingdom

RECRUITING

Investigational Site Number : 8260003

Portsmouth, Hampshire, PO3 6DW, United Kingdom

RECRUITING

Investigational Site Number : 8260009

Leeds, North Yorkshire, LS7 4SA, United Kingdom

RECRUITING

Investigational Site Number : 8260010

Nottingham, Nottinghamshire, NG17 4JL, United Kingdom

RECRUITING

Investigational Site Number : 8260008

Liverpool, L7 8XP, United Kingdom

RECRUITING

Related Links

• EFC17599 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Adrenal Cortex Hormones; Tacrolimus; pimecrolimus

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; Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

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 26, 2024
• First Posted: February 5, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): September 14, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AR (4); CA (7); DE (6); AU (2); ME (2); GR (4); SA (1); CL (5); JP (6); IL (3); CN (13); FR (6); IT (5); KR (5); TW (4); AE (3); GB (8); TU (3); PL (5); US (42); RE (1); BR (6); ES (5)