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 (AQUA)

May 7, 2026 updated by: Sanofi

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

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).

Study Overview

Status

Recruiting

Conditions

Dermatitis Atopic

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

636

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Trial Transparency email recommended (Toll free for US & Canada)
Phone Number: option 6 800-633-1610
Email: contact-us@sanofi.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1035
    - Recruiting
    - Investigational Site Number : 0320011
  - Buenos Aires, Argentina, 1426
    - Recruiting
    - Investigational Site Number : 0320019
  - Córdoba, Argentina, 5000
    - Recruiting
    - Investigational Site Number : 0320014
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Recruiting
    - Investigational Site Number : 0320007
Australia
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - Investigational Site Number : 0360006
  - Melbourne, Victoria, Australia, 3002
    - Recruiting
    - Investigational Site Number : 0360008
Brazil
- - São Paulo, Brazil, 04020-060
    - Recruiting
    - Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
  - São Paulo, Brazil, 01323-020
    - Recruiting
    - Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 41820-020
    - Recruiting
    - Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
    - Recruiting
    - Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
- São Paulo
  - Santo André, São Paulo, Brazil, 09060-650
    - Recruiting
    - Faculdade de Medicina do ABC- Site Number : 0760001
  - Sorocaba, São Paulo, Brazil, 18040-425
    - Completed
    - Clinica de Alergia Martti Antila- Site Number : 0760006
Canada
- Alberta
  - Calgary, Alberta, Canada, T2W 4X9
    - Recruiting
    - Investigational Site Number : 1240019
  - Edmonton, Alberta, Canada, T5J 3S9
    - Recruiting
    - Investigational Site Number : 1240016
- Ontario
  - Burlington, Ontario, Canada, L7L 6W6
    - Recruiting
    - Investigational Site Number : 1240058
  - Hamilton, Ontario, Canada, L8L 3C3
    - Recruiting
    - Investigational Site Number : 1240020
  - London, Ontario, Canada, N6A 5R9
    - Recruiting
    - Investigational Site Number : 1240053
  - Toronto, Ontario, Canada, M5m 3z8
    - Recruiting
    - Investigational Site Number : 1240054
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4V 1R9
    - Recruiting
    - Investigational Site Number : 1240028
Chile
- Reg Metropolitana de Santiago
  - Santiago, Reg Metropolitana de Santiago, Chile, 7580206
    - Recruiting
    - Investigational Site Number : 1520002
  - Santiago, Reg Metropolitana de Santiago, Chile, 7640881
    - Recruiting
    - Investigational Site Number : 1520003
  - Santiago, Reg Metropolitana de Santiago, Chile, 8330034
    - Recruiting
    - Investigational Site Number : 1520010
  - Santiago, Reg Metropolitana de Santiago, Chile, 8420383
    - Recruiting
    - Investigational Site Number : 1520001
  - Santiago, Reg Metropolitana de Santiago, Chile, 8380465
    - Recruiting
    - Investigational Site Number : 1520005
China
- - Changchun, China, 130021
    - Recruiting
    - Investigational Site Number : 1560031
  - Guangzhou, China, 510100
    - Recruiting
    - Investigational Site Number : 1560036
  - Guangzhou, China, 510018
    - Recruiting
    - Investigational Site Number : 1560021
  - Hangzhou, China, 310006
    - Recruiting
    - Investigational Site Number : 1560002
  - Hangzhou, China, 310003
    - Recruiting
    - Investigational Site Number : 1560044
  - Hangzhou, China, 310009
    - Recruiting
    - Investigational Site Number : 1560009
  - Nanyang, China, 473014
    - Recruiting
    - Investigational Site Number : 1560034
  - Ningbo, China, 315010
    - Recruiting
    - Investigational Site Number : 1560024
  - Ningbo, China, 315010
    - Recruiting
    - Investigational Site Number : 1560035
  - Shanghai, China, 200040
    - Recruiting
    - Investigational Site Number : 1560001
  - Shanghai, China, 200443
    - Recruiting
    - Investigational Site Number : 1560005
  - Shenyang, China, 110001
    - Recruiting
    - Investigational Site Number : 1560041
  - Wuhan, China, 430030
    - Recruiting
    - Investigational Site Number : 1560038
  - Xi'an, China, 710004
    - Recruiting
    - Investigational Site Number : 1560032
France
- - Bordeaux, France, 33000
    - Recruiting
    - Investigational Site Number : 2500011
  - Clermont-Ferrand, France, 63100
    - Active, not recruiting
    - Investigational Site Number : 2500014
  - Créteil, France, 94010
    - Recruiting
    - Investigational Site Number : 2500004
  - Lille, France, 59037
    - Recruiting
    - Investigational Site Number : 2500001
  - Paris, France, 75010
    - Recruiting
    - Investigational Site Number : 2500017
  - Rouen, France, 76031
    - Recruiting
    - Investigational Site Number : 2500012
Germany
- - Berlin, Germany, 10117
    - Recruiting
    - Investigational Site Number : 2762203
  - Blankenfelde-Mahlow, Germany, 15831
    - Recruiting
    - Investigational Site Number : 2762202
  - Dresden, Germany, 01307
    - Recruiting
    - Investigational Site Number : 2761001
  - Frankfurt, Germany, 60590
    - Recruiting
    - Investigational Site Number : 2760022
  - Lübeck, Germany, 23562
    - Recruiting
    - Investigational Site Number : 2761002
  - Witten, Germany, 58453
    - Recruiting
    - Investigational Site Number : 2760019
Greece
- - Athens, Greece, 16121
    - Recruiting
    - Investigational Site Number : 3000001
  - Athens, Greece, 124 62
    - Recruiting
    - Investigational Site Number : 3000004
  - Athens, Greece, 16121
    - Recruiting
    - Investigational Site Number : 3000005
  - Thessaloniki, Greece, 54643
    - Recruiting
    - Investigational Site Number : 3000002
Israel
- - Beersheba, Israel, 8457108
    - Recruiting
    - Investigational Site Number : 3760005
  - Ramat Gan, Israel, 5262100
    - Recruiting
    - Investigational Site Number : 3760008
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Investigational Site Number : 3760007
Italy
- - Chieti, Italy, 66100
    - Recruiting
    - Center for Advanced Studies and Technology-Site Number: 3800016
    - Contact:
      
      Camilla Federici
      
      Phone Number: 0871541374
      
      Email: crcsperimentazioni@unich.it
    - Principal Investigator:
      
      Paolo Amerio
  - Modena, Italy, 41125
    - Recruiting
    - A.O.U. di Modena -Site Number: 3800021
    - Contact:
      
      Mario Guanti
      
      Email: marioguanti@hotmail.it
    - Principal Investigator:
      
      Caterina Longo
  - Naples, Italy, 80131
    - Recruiting
    - UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"-Site Number : 3800017
    - Contact:
      
      Margherita Auriemma
      
      Phone Number: +39 081 566 6669
      
      Email: infodermostudi@gmail.com
    - Principal Investigator:
      
      Anna Balato
  - Perugia, Italy, 06129
    - Recruiting
    - Azienda ospedaliera di Perugia - Ospedale "Santa Maria della Misericordia"-Site Number: 3800015
    - Contact:
      
      Luca Stingeni
      
      Email: clinica.dermatologicaperugia@unipg.it
    - Principal Investigator:
      
      Luca Stingeni
- Torino
  - Turin, Torino, Italy, 10126
    - Recruiting
    - Investigational Site Number : 3800020
Japan
- - Hiroshima, Japan, 734-8551
    - Recruiting
    - Investigational Site Number : 3920007
- Kanagawa
  - Yokohama, Kanagawa, Japan, 221-0825
    - Recruiting
    - Investigational Site Number : 3923113
- Osaka
  - Habikino, Osaka, Japan, 583-8588
    - Recruiting
    - Investigational Site Number : 3923109
  - Sakai, Osaka, Japan, 593-8324
    - Recruiting
    - Investigational Site Number : 3923110
- Tochigi
  - Mibu, Tochigi, Japan, 321-0293
    - Recruiting
    - Investigational Site Number : 3923106
- Tokyo
  - Tachikawa, Tokyo, Japan, 190-0023
    - Recruiting
    - Investigational Site Number : 3920001
Mexico
- - Veracruz, Mexico, 91900
    - Recruiting
    - Investigational Site Number : 4840003
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Recruiting
    - Investigational Site Number : 4840011
Poland
- Lower Silesian Voivodeship
  - Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
    - Recruiting
    - Investigational Site Number : 6162417
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-363
    - Recruiting
    - Investigational Site Number : 6160002
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 01-142
    - Recruiting
    - Investigational Site Number : 6162411
  - Warsaw, Masovian Voivodeship, Poland, 02-507
    - Recruiting
    - Investigational Site Number : 6160001
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-546
    - Recruiting
    - Investigational Site Number : 6160006
Reunion
- - Saint-Pierre, Reunion, 97448
    - Recruiting
    - Investigational Site Number : 2500016
Saudi Arabia
- - Riyadh, Saudi Arabia, 12713
    - Recruiting
    - Investigational Site Number : 6820001
South Korea
- Gyeonggi-do
  - Ansan-si, Gyeonggi-do, South Korea, 15355
    - Recruiting
    - Investigational Site Number : 4100002
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Investigational Site Number : 4100014
- Incheon-gwangyeoksi
  - Bupyeong-Gu, Incheon-gwangyeoksi, South Korea, 21431
    - Recruiting
    - Investigational Site Number : 4100015
- Seoul-teukbyeolsi
  - Seoul, Seoul-teukbyeolsi, South Korea, 03722
    - Recruiting
    - Investigational Site Number : 4100007
  - Seoul, Seoul-teukbyeolsi, South Korea, 07441
    - Recruiting
    - Investigational Site Number : 4100001
Spain
- - Alicante, Spain, 03010
    - Recruiting
    - Investigational Site Number : 7242505
  - Madrid, Spain, 28046
    - Recruiting
    - Investigational Site Number : 7242503
- Barcelona [Barcelona]
  - Badalona, Barcelona [Barcelona], Spain, 08916
    - Recruiting
    - Investigational Site Number : 7240002
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Recruiting
    - Investigational Site Number : 7240017
- Sevilla
  - Seville, Sevilla, Spain, 41013
    - Recruiting
    - Investigational Site Number : 7240020
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Active, not recruiting
    - Investigational Site Number : 1583201
  - Taipei, Taiwan, 100
    - Recruiting
    - Investigational Site Number : 1580001
  - Taipei, Taiwan
    - Recruiting
    - Investigational Site Number : 1580003
  - Taoyuan City, Taiwan, 333
    - Recruiting
    - Investigational Site Number : 1583203
Turkey (Türkiye)
- - Gaziantep, Turkey (Türkiye), 27310
    - Recruiting
    - Investigational Site Number : 7920008
  - Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Investigational Site Number : 7920002
  - Istanbul, Turkey (Türkiye), 34093
    - Recruiting
    - Investigational Site Number : 7920005
United Arab Emirates
- - Abu Dhabi, United Arab Emirates
    - Recruiting
    - Investigational Site Number : 7840002
  - Abu Dhabi, United Arab Emirates, 51900
    - Recruiting
    - Investigational Site Number : 7841002
  - Abu Dhabi, United Arab Emirates, 6222
    - Recruiting
    - Investigational Site Number : 7840001
United Kingdom
- - Liverpool, United Kingdom, L7 8XP
    - Recruiting
    - Investigational Site Number : 8260008
- Bristol, City of
  - Bristol, Bristol, City of, United Kingdom, BS2 8HW
    - Recruiting
    - Investigational Site Number : 8260013
- Devon
  - Plymouth, Devon, United Kingdom, PL6 8DH
    - Recruiting
    - Investigational Site Number : 8260012
- England
  - London, England, United Kingdom, E11 1NR
    - Recruiting
    - Investigational Site Number : 8262603
  - London, England, United Kingdom, SW10 9NH
    - Recruiting
    - Investigational Site Number : 8260015
- Hampshire
  - Portsmouth, Hampshire, United Kingdom, PO3 6DW
    - Recruiting
    - Investigational Site Number : 8260003
- North Yorkshire
  - Leeds, North Yorkshire, United Kingdom, Ls7 4sa
    - Recruiting
    - Investigational Site Number : 8260009
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG17 4JL
    - Recruiting
    - Investigational Site Number : 8260010
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - University of Alabama at Birmingham- Site Number : 8401267
- Arizona
  - Scottsdale, Arizona, United States, 85260
    - Recruiting
    - Center for Dermatology and Plastic Surgery- Site Number : 8401119
- Arkansas
  - North Little Rock, Arkansas, United States, 72117
    - Recruiting
    - Arkansas Dermatology - North Little Rock- Site Number : 8401244
- California
  - Encino, California, United States, 91436
    - Recruiting
    - Encino Research Center- Site Number : 8401042
  - Fremont, California, United States, 94538
    - Recruiting
    - Center for Dermatology Clinical Research- Site Number : 8401018
  - Long Beach, California, United States, 90806
    - Recruiting
    - Long Beach Clinical Trials- Site Number : 8401188
  - Los Angeles, California, United States, 90045
    - Recruiting
    - Dermatology Research Associates - Los Angeles- Site Number : 8401092
  - Los Angeles, California, United States, 90057
    - Recruiting
    - LA Universal Research Center- Site Number : 8401064
  - Newport Beach, California, United States, 92660
    - Recruiting
    - University Dermatology Trials- Site Number : 8401339
  - San Diego, California, United States, 92123
    - Recruiting
    - Therapeutics Clinical Research- Site Number : 8401283
  - San Diego, California, United States, 92123
    - Recruiting
    - Rady Children's Hospital- Site Number : 8401291
- Colorado
  - Wheat Ridge, Colorado, United States, 80033
    - Recruiting
    - Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
- Florida
  - Boynton Beach, Florida, United States, 33436
    - Recruiting
    - Encore Medical Research of Boynton Beach- Site Number : 8401030
  - Doral, Florida, United States, 33172
    - Recruiting
    - St. Jude Clinical Research- Site Number : 8401287
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Apex Clinical Research - Jacksonville- Site Number : 8401332
  - St. Petersburg, Florida, United States, 33705
    - Recruiting
    - Global Clinical Professionals (GCP)- Site Number : 8401045
  - Tampa, Florida, United States, 33613
    - Recruiting
    - Avita Clinical Research- Site Number : 8401073
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern University- Site Number : 8401285
  - Skokie, Illinois, United States, 60077
    - Recruiting
    - NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
- Indiana
  - Indianapolis, Indiana, United States, 46256
    - Recruiting
    - Dawes Fretzin Clinical Research- Site Number : 8401015
- Kentucky
  - Bowling Green, Kentucky, United States, 42104
    - Recruiting
    - Equity Medical - Bowling Green- Site Number : 8401296
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - Tandem Clinical Research - Metairie- Site Number : 8401187
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Health System - Ann Arbor- Site Number : 8401290
  - Northville, Michigan, United States, 48167
    - Recruiting
    - MI Skin Center- Site Number : 8401307
- Nebraska
  - Omaha, Nebraska, United States, 68144
    - Recruiting
    - Skin Specialists- Site Number : 8401068
- New Jersey
  - East Windsor, New Jersey, United States, 08520
    - Recruiting
    - Schweiger Dermatology Group - East Windsor- Site Number : 8401338
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Recruiting
    - The University of New Mexico- Site Number : 8401263
- New York
  - New York, New York, United States, 10075
    - Recruiting
    - Sadick Research Group - New York - Park Avenue- Site Number : 8401050
  - New York, New York, United States, 10023
    - Recruiting
    - Equity Medical- Site Number : 8401239
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Recruiting
    - Cincinnati Children's Hospital Medical Center- Site Number : 8401279
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health & Science University (OHSU)- Site Number : 8401247
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19103
    - Recruiting
    - Paddington Testing Company- Site Number : 8401041
  - Philadelphia, Pennsylvania, United States, 19114
    - Recruiting
    - Clinical Research of Philadelphia- Site Number : 8401193
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282
- Texas
  - Arlington, Texas, United States, 76011
    - Recruiting
    - Arlington Research Center- Site Number : 8401248
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288
  - Dallas, Texas, United States, 75235
    - Recruiting
    - Reveal Research Institute - Dallas- Site Number : 8401219
- Utah
  - Ogden, Utah, United States, 84405
    - Recruiting
    - Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
- Washington
  - Mill Creek, Washington, United States, 98012
    - Recruiting
    - North Sound Dermatology- Site Number : 8401280
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Children's Wisconsin- Site Number : 8401246
- Wyoming
  - Cheyenne, Wyoming, United States, 82009
    - Recruiting
    - Cheyenne Skin Clinic- Site Number : 8401234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlitelimab dose 1 Subcutaneous injection as per protocol	Drug: Amlitelimab Pharmaceutical form: Injection solution Route of administration: Subcutaneous Other Names: SAR445229 Drug: Topical corticosteroids Pharmaceutical form: Various Topical formulation Route of administration: Topical Drug: Topical tacrolimus or pimecrolimus Pharmaceutical form: Various Topical formulation Route of administration: Topical
Experimental: Amlitelimab dose 2 Subcutaneous injection as per protocol	Drug: Amlitelimab Pharmaceutical form: Injection solution Route of administration: Subcutaneous Other Names: SAR445229 Drug: Topical corticosteroids Pharmaceutical form: Various Topical formulation Route of administration: Topical Drug: Topical tacrolimus or pimecrolimus Pharmaceutical form: Various Topical formulation Route of administration: Topical
Placebo Comparator: Placebo Subcutaneous injection as per protocol	Drug: Placebo Pharmaceutical form: Injection solution Route of administration: Subcutaneous Drug: Topical corticosteroids Pharmaceutical form: Various Topical formulation Route of administration: Topical Drug: Topical tacrolimus or pimecrolimus Pharmaceutical form: Various Topical formulation Route of administration: Topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: Baseline to Week 36	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 36
Proportion of participants reaching EASI-75 Time Frame: Baseline to 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. EASI-75 is 75% reduction from baseline in EASI score.	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 Time Frame: Baseline to 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).	Baseline to Week 24
Proportion of participants reaching EASI-90 Time Frame: Baseline to 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. EASI-90 is 90% reduction from baseline in EASI score.	Baseline to Week 36
Proportion of participants reaching EASI-100 Time Frame: Baseline to 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. EASI-100 is 100% reduction from baseline in EASI score.	Baseline to Week 36
Change in Hospital Anxiety Depression Scale (HADS) from baseline Time Frame: Baseline to Week 36	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Baseline to Week 36
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8 Time Frame: Baseline to Week 36	HADS-A score ranges 0-21 with higher score indicating a poorer state.	Baseline to Week 36
Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8 Time Frame: Baseline to Week 36	HADS-D score ranges 0-21 with higher score indicating a poorer state.	Baseline to Week 36
Proportion of participants with a reduction in weekly average of daily SP-NRS ≥4 from baseline in participants with baseline weekly average of daily SP-NRS ≥4 Time Frame: Baseline to Week 36	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Baseline to Week 36
Proportion of participants with a reduction in weekly average of daily SD-NRS ≥3 from baseline in participants with Baseline weekly average of daily SD-NRS ≥3 Time Frame: Baseline to Week 36	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Baseline to Week 36
Percent change in EASI score from baseline Time Frame: Baseline to 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.	Baseline to Week 36
Percent change in weekly average of daily PP-NRS from baseline Time Frame: Baseline to Week 36	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 36
Proportion of participants reaching EASI-50 Time Frame: Baseline to 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. EASI-50 is 50% reduction from baseline in EASI score.	Baseline to Week 36
Proportion of participants with EASI ≤7 Time Frame: Baseline to 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.	Baseline to Week 36
Change in percent Body Surface Area (BSA) affected by AD from baseline Time Frame: Baseline to Week 36		Baseline to Week 36
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline Time Frame: Baseline to Week 36	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Baseline to Week 36
Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7 Time Frame: Baseline to Week 36	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Baseline to Week 36
Proportion of participants with a reduction in Patient Oriented Eczema Measure (POEM) ≥4 from baseline in participants with POEM Baseline ≥4 Time Frame: Baseline to Week 36	The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.	Baseline to Week 36
Change in POEM from baseline Time Frame: Baseline to Week 36	The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.	Baseline to Week 36
Proportion of participants with rescue medication use Time Frame: Baseline to Week 36		Baseline to Week 36
Percentage of TCS/TCI free days Time Frame: Baseline to Week 36		Baseline to Week 36
Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), experienced Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI) Time Frame: Baseline to Week 52		Baseline to Week 52
Serum amlitelimab concentrations Time Frame: Baseline to Week 52		Baseline to Week 52
Incidence of antidrug antibodies (ADAs) of amlitelimab Time Frame: Baseline to Week 52		Baseline to Week 52
Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4 Time Frame: Baseline to Week 36	The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Baseline to Week 36
Proportion of participants with a reduction in CDLQI ≥6 from baseline in participants with age ≥12 to <16 years old and with CDLQI baseline ≥6 Time Frame: Baseline to Week 36	The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Baseline to Week 36
Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline Time Frame: Baseline to Week 36	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Baseline to Week 36
Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline Time Frame: Baseline to Week 36	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Baseline to Week 36
Absolute change in weekly average of daily PP-NRS from baseline Time Frame: Baseline to Week 36	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 36
Absolute change in SCORAD index from baseline Time Frame: Baseline to Week 36	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Baseline to Week 36
Time to onset of effect on PP-NRS as measured by proportion of participants with an improvement (reduction) in PP-NRS by ≥4 Time Frame: Baseline to Week 36	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 36
Time to onset of effect on vIGA-AD as measured by proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and a reduction from baseline ≥2 during the 36-week treatment period Time Frame: Baseline to 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).	Baseline to Week 36
Time to onset of effect on EASI as measured by proportion of participants reaching a 75% reduction from baseline in EASI score during the 36-week treatment period Time Frame: Baseline to 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. EASI-75 is 75% reduction from baseline in EASI score.	Baseline to Week 36
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old Time Frame: Baseline to Week 36	The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Baseline to Week 36
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years Time Frame: Baseline to Week 36	The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Baseline to Week 36
Percent change in weekly average of daily SD-NRS Time Frame: Baseline to Week 36	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Baseline to 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) Time Frame: Baseline to 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).	Baseline to Week 36
Percent change in weekly average of daily SP-NRS from baseline Time Frame: Baseline to Week 36	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Baseline to Week 36
Proportion of participants with vIGA-AD 0 (clear) Time Frame: Baseline to 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).	Baseline to Week 36
Proportion of participants reaching EASI-75 at Week 36 (for US and US reference countries only) Time Frame: 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. EASI-75 is 75% reduction from baseline in EASI score.	Week 36
Proportion of participants with PP-NRS ≤1 Time Frame: Baseline to Week 36	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

EFC17599 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 29, 2028

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC17599 (Sanofi Identifier)
2023-508099-12 (Registry Identifier: CTIS)
U1111-1295-3059 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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