AzTrials
AzTrials

Dermatitis AtopicPhase 3AQUANCT06241118

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

A Phase 3 study testing Amlitelimab, Topical corticosteroids and Topical tacrolimus or pimecrolimus in people with Dermatitis Atopic, run by Sanofi at 154 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Dermatitis Atopic
What is being tested?
Amlitelimab, Topical corticosteroids and Topical tacrolimus or pimecrolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
464 participants
Where
154 sitesin 22 countries
Study dates
29 Feb 2024to 29 Sep 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

154 sites in 22 countries.

154 sites in 22 countries

United States43 sites

  • The University of New Mexico- Site Number : 8401263

    Albuquerque, New Mexico, 87106

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

    Ann Arbor, Michigan, 48109

  • Arlington Research Center- Site Number : 8401248

    Arlington, Texas, 76011

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

    Bellaire, Texas, 77401

  • University of Alabama at Birmingham- Site Number : 8401267

    Birmingham, Alabama, 35233

  • Equity Medical - Bowling Green- Site Number : 8401296

    Bowling Green, Kentucky, 42104

  • Encore Medical Research of Boynton Beach- Site Number : 8401030

    Boynton Beach, Florida, 33436

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

    Charleston, South Carolina, 29425

  • Cheyenne Skin Clinic- Site Number : 8401234

    Cheyenne, Wyoming, 82009

  • Northwestern University- Site Number : 8401285

    Chicago, Illinois, 60611

  • Exalt Clinical Research- Site Number : 8401344

    Chula Vista, California, 91910

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

    Cincinnati, Ohio, 45229

  • Reveal Research Institute - Dallas- Site Number : 8401219

    Dallas, Texas, 75235

  • St. Jude Clinical Research- Site Number : 8401287

    Doral, Florida, 33172

  • Schweiger Dermatology Group - East Windsor- Site Number : 8401338

    East Windsor, New Jersey, 08520

  • Encino Research Center- Site Number : 8401042

    Encino, California, 91436

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538

  • Dawes Fretzin Clinical Research- Site Number : 8401015

    Indianapolis, Indiana, 46256

  • Apex Clinical Research - Jacksonville- Site Number : 8401332

    Jacksonville, Florida, 32256

  • Long Beach Clinical Trials- Site Number : 8401188

    Long Beach, California, 90806

  • Dermatology Research Associates- Site Number : 8401092

    Los Angeles, California, 90045

  • LA Universal Research Center- Site Number : 8401064

    Los Angeles, California, 90057

  • Tandem Clinical Research - Metairie- Site Number : 8401187

    Metairie, Louisiana, 70006

  • Clever Medical Research- Site Number : 8401160

    Miami, Florida, 33126

  • Future Care Solution - Miami- Site Number : 8401340

    Miami, Florida, 33142

  • North Sound Dermatology- Site Number : 8401280

    Mill Creek, Washington, 98012

  • Children's Wisconsin- Site Number : 8401246

    Milwaukee, Wisconsin, 53226

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

    New York, New York, 10075

  • University Dermatology Trials- Site Number : 8401339

    Newport Beach, California, 92660

  • Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

    Norfolk, Virginia, 23502

  • Arkansas Dermatology - North Little Rock- Site Number : 8401244

    North Little Rock, Arkansas, 72117

  • MI Skin Center- Site Number : 8401307

    Northville, Michigan, 48167

  • Paddington Testing Company- Site Number : 8401041

    Philadelphia, Pennsylvania, 19103

  • Clinical Research of Philadelphia- Site Number : 8401193

    Philadelphia, Pennsylvania, 19114

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

    Portland, Oregon, 97239

  • Rady Children's Hospital- Site Number : 8401291

    San Diego, California, 92123

  • Therapeutics Clinical Research- Site Number : 8401283

    San Diego, California, 92123

  • Center for Dermatology and Plastic Surgery- Site Number : 8401119

    Scottsdale, Arizona, 85260

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

    Skokie, Illinois, 60077

  • Global Clinical Professionals (GCP)- Site Number : 8401045

    St. Petersburg, Florida, 33714

  • Avita Clinical Research- Site Number : 8401073

    Tampa, Florida, 33613

  • Equity Medical (LLC)- Site Number : 8401239

    The Bronx, New York, 10455

  • Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

    Wheat Ridge, Colorado, 80033

Other trials in United States

China15 sites

  • Investigational Site Number : 1560031

    Changchun, 130021

  • Investigational Site Number : 1560057

    Chongqing, 400016

  • Investigational Site Number : 1560021

    Guangzhou, 510018

  • Investigational Site Number : 1560036

    Guangzhou, 510100

  • Investigational Site Number : 1560044

    Hangzhou, 310003

  • Investigational Site Number : 1560002

    Hangzhou, 310006

  • Investigational Site Number : 1560009

    Hangzhou, 310009

  • Investigational Site Number : 1560034

    Nanyang, 473014

  • Investigational Site Number : 1560024

    Ningbo, 315010

  • Investigational Site Number : 1560035

    Ningbo, 315010

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560005

    Shanghai, 200443

  • Investigational Site Number : 1560041

    Shenyang, 110001

  • Investigational Site Number : 1560038

    Wuhan, 430030

  • Investigational Site Number : 1560032

    Xi'an, 710004

Other trials in China

Canada9 sites

  • Investigational Site Number : 1240058

    Burlington, Ontario, L7L 6W6

  • Investigational Site Number : 1240019

    Calgary, Alberta, T2W 4X9

  • Investigational Site Number : 1240016

    Edmonton, Alberta, T5J 3S9

  • Investigational Site Number : 1240020

    Hamilton, Ontario, L8L 3C3

  • Investigational Site Number : 1240053

    London, Ontario, N6A 5R9

  • Investigational Site Number : 1240006

    Québec, Quebec, G1W 4R4

  • Investigational Site Number : 1240028

    Regina, Saskatchewan, S4V 1R9

  • Investigational Site Number : 1240035

    Toronto, Ontario, M5A 3R6

  • Investigational Site Number : 1240054

    Toronto, Ontario, M5m 3z8

Other trials in Canada

Argentina8 sites

  • Investigational Site Number : 0320011

    Buenos Aires, 1035

  • Investigational Site Number : 0320008

    Buenos Aires, 1061

  • Investigational Site Number : 0320010

    Buenos Aires, 1414

  • Investigational Site Number : 0320004

    Buenos Aires, 1425

  • Investigational Site Number : 0320019

    Buenos Aires, 1426

  • Investigational Site Number : 0320014

    Córdoba, 5000

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320024

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Japan8 sites

  • Investigational Site Number : 3923109

    Habikino, Osaka, 583-8588

  • Investigational Site Number : 3920007

    Hiroshima, 734-8551

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293

  • Investigational Site Number : 3923107

    Minato, Tokyo, 108-0014

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324

  • Investigational Site Number : 3920008

    Sapporo, 064-0921

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825

Other trials in Japan

United Kingdom8 sites

  • Investigational Site Number : 8260013

    Bristol, Bristol, City of, BS2 8HW

  • Investigational Site Number : 8260009

    Leeds, North Yorkshire, Ls7 4sa

  • Investigational Site Number : 8260008

    Liverpool, L7 8XP

  • Investigational Site Number : 8262603

    London, England, E11 1NR

  • Investigational Site Number : 8260015

    London, England, SW10 9NH

  • Investigational Site Number : 8260010

    Nottingham, Nottinghamshire, NG17 4JL

  • Investigational Site Number : 8260012

    Plymouth, Devon, PL6 8DH

  • Investigational Site Number : 8260003

    Portsmouth, Hampshire, PO3 6DW

Other trials in United Kingdom

France7 sites

  • Investigational Site Number : 2500011

    Bordeaux, 33000

  • Investigational Site Number : 2500014

    Clermont-Ferrand, 63100

  • Investigational Site Number : 2500004

    Créteil, 94010

  • Investigational Site Number : 2500001

    Lille, 59037

  • Investigational Site Number : 2500017

    Paris, 75010

  • Investigational Site Number : 2500012

    Rouen, 76031

  • Investigational Site Number : 2500016

    Saint-Pierre, 97410

Other trials in France

Brazil6 sites

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

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

    Salvador, Estado de Bahia, 41820-020

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, São Paulo, 09060-650

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

    São Paulo, 01323-020

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

    São Paulo, 04020-060

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Chile6 sites

  • Investigational Site Number : 1520013

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520010

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8380465

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383

Other trials in Chile

Germany6 sites

  • Investigational Site Number : 2762203

    Berlin, 10117

  • Investigational Site Number : 2762202

    Blankenfelde-Mahlow, 15831

  • Investigational Site Number : 2761001

    Dresden, 01307

  • Investigational Site Number : 2760022

    Frankfurt, 60590

  • Investigational Site Number : 2761002

    Lübeck, 23562

  • Investigational Site Number : 2760019

    Witten, 58453

Other trials in Germany

Italy5 sites

  • Center for Advanced Studies and Technology-Site Number: 3800016

    Chieti, 66100

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

    Modena, 41125

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

    Naples, 80131

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

    Perugia, 06129

  • Investigational Site Number : 3800020

    Turin, Torino, 10126

Other trials in Italy

Spain5 sites

  • Investigational Site Number : 7242505

    Alicante, 03010

  • Investigational Site Number : 7240002

    Badalona, Barcelona [Barcelona], 08916

  • Investigational Site Number : 7240018

    Granada, 18014

  • Investigational Site Number : 7242503

    Madrid, Madrid, Comunidad de, 28046

  • Investigational Site Number : 7240017

    Majadahonda, Madrid, 28222

Other trials in Spain

Greece4 sites

  • Investigational Site Number : 3000004

    Athens, 124 62

  • Investigational Site Number : 3000001

    Athens, 16121

  • Investigational Site Number : 3000005

    Athens, 16121

  • Investigational Site Number : 3000002

    Thessaloniki, 54643

Other trials in Greece

South Korea4 sites

  • Investigational Site Number : 4100002

    Ansan-si, Gyeonggi-do, 15355

  • Investigational Site Number : 4100015

    Bupyeong-Gu, Incheon-gwangyeoksi, 21431

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 07441

Other trials in South Korea

Taiwan4 sites

  • Investigational Site Number : 1583201

    Kaohsiung City, 833

  • Investigational Site Number : 1580001

    Taipei, 100

  • Investigational Site Number : 1580003

    Taipei, NaN

  • Investigational Site Number : 1583203

    Taoyuan City, 333

Other trials in Taiwan

Israel3 sites

  • Investigational Site Number : 3760005

    Beersheba, 8457108

  • Investigational Site Number : 3760008

    Ramat Gan, 5262100

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)3 sites

  • Investigational Site Number : 7920008

    Gaziantep, 27310

  • Investigational Site Number : 7920005

    Istanbul, 34093

  • Investigational Site Number : 7920002

    Istanbul, 34098

Other trials in Turkey (Türkiye)

United Arab Emirates3 sites

  • Investigational Site Number : 7841002

    Abu Dhabi, 51900

  • Investigational Site Number : 7840001

    Abu Dhabi

  • Investigational Site Number : 7840002

    Abu Dhabi

Other trials in United Arab Emirates

Australia2 sites

  • Investigational Site Number : 0360008

    Melbourne, Victoria, 3002

  • Investigational Site Number : 0360006

    Melbourne, Victoria, 3004

Other trials in Australia

Mexico2 sites

  • Investigational Site Number : 4840011

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4840003

    Veracruz, 91900

Other trials in Mexico

Poland2 sites

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546

  • Investigational Site Number : 6162411

    Warsaw, Masovian Voivodeship, 01-142

Other trials in Poland

Saudi Arabia1 site

  • Investigational Site Number : 6820001

    Riyadh, 12713

Other trials in Saudi Arabia

About this study

Official title: 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.

Read more

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).

Being tested
Amlitelimab, Placebo, Topical corticosteroids, Topical tacrolimus or pimecrolimus
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlitelimabDrug

    Also called SAR445229

    Pharmaceutical form: Injection solution Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Injection solution Route of administration: Subcutaneous

  • Topical corticosteroidsDrug

    Pharmaceutical form: Various Topical formulation Route of administration: Topical

  • Topical tacrolimus or pimecrolimusDrug

    Pharmaceutical form: Various Topical formulation Route of administration: Topical

Study groups in NCT06241118
Study groupRoleWhat they receive
Amlitelimab dose 1ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical tacrolimus or pimecrolimus
Amlitelimab dose 2ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical tacrolimus or pimecrolimus
PlaceboPlacebo comparatorSubcutaneous injection as per protocol
Receives: Drug: Placebo; Drug: Topical corticosteroids; Drug: Topical tacrolimus or pimecrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 36

  2. 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.

    Measured: Week 36

  3. 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).

    Measured: Week 36

Secondary outcomes (41)

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

    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.

    Measured: Week 36

  2. 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)

    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).

    Measured: Baseline to Week 36

  3. 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

    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.

    Measured: Baseline to Week 36

  4. Proportion of participants reaching EASI-75

    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.

    Measured: Baseline to Week 24

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

    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).

    Measured: Baseline to Week 24

  6. Proportion of participants reaching EASI-90

    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.

    Measured: Baseline to Week 36

  7. Proportion of participants reaching EASI-100

    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.

    Measured: Baseline to Week 36

  8. Proportion of participants with PP-NRS ≤1

    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.

    Measured: Baseline to Week 36

  9. Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old

    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.

    Measured: Baseline to Week 36

  10. Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4

    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.

    Measured: Baseline to Week 36

  11. Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years

    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.

    Measured: Baseline to Week 36

  12. 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

    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.

    Measured: Baseline to Week 36

  13. Change in Hospital Anxiety Depression Scale (HADS) from baseline

    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.

    Measured: Baseline to Week 36

  14. Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8

    HADS-A score ranges 0-21 with higher score indicating a poorer state.

    Measured: Baseline to Week 36

  15. Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8

    HADS-D score ranges 0-21 with higher score indicating a poorer state.

    Measured: Baseline to Week 36

  16. Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline

    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.

    Measured: Baseline to Week 36

  17. 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

    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.

    Measured: Baseline to Week 36

  18. Percent change in weekly average of daily SP-NRS from baseline

    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.

    Measured: Baseline to Week 36

  19. Proportion of participants with vIGA-AD 0 (clear)

    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).

    Measured: Baseline to Week 36

  20. Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline

    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.

    Measured: Baseline to Week 36

  21. 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

    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.

    Measured: Baseline to Week 36

  22. Percent change in weekly average of daily SD-NRS

    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.

    Measured: Baseline to Week 36

  23. Percent change in EASI score from baseline

    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.

    Measured: Baseline to Week 36

  24. Percent change in weekly average of daily PP-NRS from baseline

    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.

    Measured: Baseline to Week 36

  25. Absolute change in weekly average of daily PP-NRS from baseline

    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.

    Measured: Baseline to Week 36

  26. Proportion of participants reaching EASI-50

    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.

    Measured: Baseline to Week 36

  27. Proportion of participants with EASI ≤7

    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.

    Measured: Baseline to Week 36

  28. Change in percent Body Surface Area (BSA) affected by AD from baseline

    Measured: Baseline to Week 36

  29. Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline

    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).

    Measured: Baseline to Week 36

  30. Absolute change in SCORAD index from baseline

    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).

    Measured: Baseline to Week 36

  31. Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7

    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).

    Measured: Baseline to Week 36

  32. Proportion of participants with a reduction in Patient Oriented Eczema Measure (POEM) ≥4 from baseline in participants with POEM Baseline ≥4

    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.

    Measured: Baseline to Week 36

  33. Change in POEM from baseline

    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.

    Measured: Baseline to Week 36

  34. Proportion of participants with rescue medication use

    Measured: Baseline to Week 36

  35. Time to onset of effect on PP-NRS as measured by proportion of participants with an improvement (reduction) in PP-NRS by ≥4

    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.

    Measured: Baseline to Week 36

  36. Percentage of TCS/TCI free days

    Measured: Baseline to Week 36

  37. 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)

    Measured: Baseline to Week 52

  38. Serum amlitelimab concentrations

    Measured: Baseline to Week 52

  39. Incidence of antidrug antibodies (ADAs) of amlitelimab

    Measured: Baseline to Week 52

  40. 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

    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).

    Measured: Baseline to Week 36

  41. 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

    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.

    Measured: Baseline to Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start29 Feb 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion29 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06241118
Sponsor's protocol ID
EFC17599
Other IDs
2023-508099-12, U1111-1295-3059, 2023
Acronym
AQUA
Status last verified
Oct 2026
First submitted
26 Jan 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlitelimab, Topical corticosteroids and Topical tacrolimus or pimecrolimus in people with Dermatitis Atopic, run by Sanofi at 154 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, China, Canada, Argentina, Japan and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06241118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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