AzTrials
AzTrials

Dermatitis AtopicPhase 3SHORENCT06224348

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

A Phase 3 study testing Amlitelimab, Topical corticosteroids and Topical calcineurin inhibitors in people with Dermatitis Atopic, run by Sanofi at 167 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or… 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 calcineurin inhibitors
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
643 participants
Where
167 sitesin 14 countries
Study dates
18 Jan 2024to 1 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

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 (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
  • v-IGA-AD of 3 or 4 at baseline visit
  • EASI score of 16 or higher at baseline
  • AD involvement of 10% or more of BSA at baseline
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

167 sites in 14 countries.

167 sites in 14 countries

United States40 sites

  • Cahaba Dermatology & Skin Health Center- Site Number : 8401066

    Birmingham, Alabama, 35244

  • Cope Family Medicine - Ogden Clinic- Site Number : 8401114

    Bountiful, Utah, 84010

  • Vial Health - DermDox Dermatology- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011

  • Clinical Research Center of the Carolinas- Site Number : 8401067

    Charleston, South Carolina, 29407

  • Cleaver Medical Group- Site Number : 8401138

    Dawsonville, Georgia, 30534

  • Encino Research Center- Site Number : 8401042

    Encino, California, 91436

  • Johnson Dermatology- Site Number : 8401076

    Fort Smith, Arkansas, 72916

  • BRCR Global Gretna- Site Number : 8401243

    Gretna, Louisiana, 70053

  • Skin Care Research - Hollywood- Site Number : 8401071

    Hollywood, Florida, 33021

  • Marvel Clinical Research- Site Number : 8401102

    Huntington Beach, California, 92647

  • Dawes Fretzin Clinical Research- Site Number : 8401015

    Indianapolis, Indiana, 46256

  • Jubilee Clinical Research- Site Number : 8401054

    Las Vegas, Nevada, 89106

  • Tanner Clinic - Layton Antelope A- Site Number : 8401151

    Layton, Utah, 84041

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

    Lee's Summit, Missouri, 64064

  • LA Universal Research Center- Site Number : 8401064

    Los Angeles, California, 90057

  • Apex Clinical Research Center- Site Number : 8401237

    Mayfield Heights, Ohio, 44124

  • SMS Clinical Research- Site Number : 8401182

    Mesquite, Texas, 75149

  • Clever Medical Research- Site Number : 8401160

    Miami, Florida, 33126

  • Acevedo Clinical Research Associates- Site Number : 8401088

    Miami, Florida, 33142

  • Palm Springs Community Health Center- Site Number : 8401264

    Miami Lakes, Florida, 33016

  • Sienna Dermatology- Site Number : 8401148

    Missouri City, Texas, 77459

  • Velocity Clinical Research - New Orleans- Site Number : 8401155

    New Orleans, Louisiana, 70119

  • Equity Medical- Site Number : 8401239

    New York, New York, 10023

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

    New York, New York, 10029

  • OptiSkin- Site Number : 8401163

    New York, New York, 10128

  • Skin Specialists- Site Number : 8401068

    Omaha, Nebraska, 68144

  • Cura Clinical Research- Site Number : 8401141

    Palmdale, California, 93551

  • Allcutis Research - Portsmouth- Site Number : 8401082

    Portsmouth, New Hampshire, 03801

  • Integrative Skin Science and Research- Site Number : 8401275

    Sacramento, California, 95815

  • Texas Dermatology and Laser Specialists- Site Number : 8401131

    San Antonio, Texas, 78218

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

    San Antonio, Texas, 78258

  • Southern California Dermatology- Site Number : 8401043

    Santa Ana, California, 92701

  • NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038

    Skokie, Illinois, 60076

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

    St. Petersburg, Florida, 33705

  • Complete Dermatology - Sugar Land- Site Number : 8401061

    Sugar Land, Texas, 77479

  • University of South Florida- Site Number : 8401070

    Tampa, Florida, 33612

  • Avita Clinical Research- Site Number : 8401073

    Tampa, Florida, 33613

  • Oakland Medical Center- Site Number : 8401116

    Troy, Michigan, 48085

  • Essential Medical Research- Site Number : 8401183

    Tulsa, Oklahoma, 74137

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

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan19 sites

  • Investigational Site Number : 3920009

    Chitose, Hokkaido, 066-0021

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0031

  • Investigational Site Number : 3923109

    Habikino, 583-8588

  • Investigational Site Number : 3920002

    Iruma, Saitama, 350-0495

  • Investigational Site Number : 3923108

    Kagoshima, 890-0063

  • Investigational Site Number : 3920006

    Kobe, Hyōgo, 653-0836

  • Investigational Site Number : 3923102

    Kyoto, 602-8566

  • Investigational Site Number : 3920003

    Kyoto, 606-8507

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293

  • Investigational Site Number : 3923107

    Minato, Tokyo, 108-0014

  • Investigational Site Number : 3920010

    Miyagi-gun, Miyagi, 981-0112

  • Investigational Site Number : 3923114

    Obihiro, Hokkaido, 080-0013

  • Investigational Site Number : 3920005

    Sagamihara, Kanagawa, 252-0315

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324

  • Investigational Site Number : 3920008

    Sapporo, Hokkaido, 064-0921

  • Investigational Site Number : 3920011

    Sendai, Miyagi, 981-3133

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825

  • Investigational Site Number : 3923113

    Yokohama, 221-0825

Other trials in Japan

Canada13 sites

  • Investigational Site Number : 1240057

    Brampton, Ontario, L6Z1Y4

  • Investigational Site Number : 1240039

    Calgary, Alberta, T2J 7E1

  • Investigational Site Number : 1240046

    Kamloops, British Columbia, V1Y 4N7

  • Investigational Site Number : 1241106

    Markham, Ontario, L3P 1X2

  • Investigational Site Number : 1240008

    Mississauga, Ontario, L5H 1G9

  • Investigational Site Number : 1240004

    Peterborough, Ontario, K9J5K2

  • Investigational Site Number : 1240006

    Québec, Quebec, G1W 4R4

  • Investigational Site Number : 1240045

    Red Deer, Alberta, T4P 1K4

  • Investigational Site Number : 1240038

    Richmond Hill, Ontario, L4E 4L6

  • Investigational Site Number : 1240030

    Surrey, British Columbia, V3V 0C6

  • Investigational Site Number : 1240012

    Toronto, Ontario, M3H 5Y8

  • Investigational Site Number : 1241107

    Waterloo, Ontario, N2J 1C4

  • Investigational Site Number : 1240041

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

China12 sites

  • Investigational Site Number : 1560050

    Changsha, 410011

  • Investigational Site Number : 1560060

    Chengdu, 610072

  • Investigational Site Number : 1560043

    Fuzhou, 350005

  • Investigational Site Number : 1560021

    Guangzhou, 510018

  • Investigational Site Number : 1560044

    Hangzhou, 310003

  • Investigational Site Number : 1560006

    Hangzhou, 310009

  • Investigational Site Number : 1560051

    Nanchang, 330001

  • Investigational Site Number : 1560005

    Shanghai, 200443

  • Investigational Site Number : 1560041

    Shenyang, 110001

  • Investigational Site Number : 1560047

    Tianjin, 300052

  • Investigational Site Number : 1560049

    Wuhan, 430022

  • Investigational Site Number : 1560003

    Wuxi, 214000

Other trials in China

Argentina10 sites

  • Investigational Site Number : 0320011

    Buenos Aires, 1035

  • Investigational Site Number : 0320019

    Buenos Aires, 1056

  • Investigational Site Number : 0320008

    Buenos Aires, 1061

  • Investigational Site Number : 0320018

    Buenos Aires, 1178

  • Investigational Site Number : 0320010

    Buenos Aires, 1414

  • Investigational Site Number : 0320004

    Buenos Aires, 1425

  • Investigational Site Number : 0320005

    CABA, Buenos Aires F.D., 1427

  • Investigational Site Number : 0320012

    Corrientes, 3400

  • Investigational Site Number : 0320013

    Mendoza, 5500

  • Investigational Site Number : 0320020

    San Miguel de Tucumán, 4000

Other trials in Argentina

Chile10 sites

  • Investigational Site Number : 1520009

    Osorno, Reg Metropolitana de Santiago, 5311523

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 7500588

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520011

    Santiago, Reg Metropolitana de Santiago, 8380456

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8380465

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383

  • Investigational Site Number : 1520010

    Santiago, 8330032

  • Investigational Site Number : 1520012

    Talcahuano, 2687000

  • Investigational Site Number : 1520006

    Viña del Mar, Valparaiso, 2530900

Other trials in Chile

Germany10 sites

  • Investigational Site Number : 2760020

    Augsburg, 86150

  • Investigational Site Number : 2760009

    Bad Bentheim, 48455

  • Investigational Site Number : 2760014

    Buxtehude, 21614

  • Investigational Site Number : 2760017

    Hamburg, 20095

  • Investigational Site Number : 2760021

    Hamburg, 20354

  • Investigational Site Number : 2762208

    Kiel, 24105

  • Investigational Site Number : 2760018

    Magdeburg, 39104

  • Investigational Site Number : 2760016

    Mainz, 55128

  • Investigational Site Number : 2762201

    Münster, 48149

  • Investigational Site Number : 2760019

    Witten, 58453

Other trials in Germany

Spain10 sites

  • Investigational Site Number : 7242505

    Alicante, 03010

  • Investigational Site Number : 7240008

    Bilbao, Bizkaia, 48013

  • Investigational Site Number : 7240023

    Burjassot, Valenciana, Comunidad, 46100

  • Investigational Site Number : 7240010

    Esplugues de Llobregat, Catalunya [Cataluña], 08950

  • Investigational Site Number : 7240019

    Granada, Andalusia, 18012

  • Investigational Site Number : 7240013

    Madrid, 28031

  • Investigational Site Number : 7242502

    Manises, Valencia, 46940

  • Investigational Site Number : 7240015

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240020

    Seville, Andalusia, 41013

  • Investigational Site Number : 7240014

    Vigo, 36206

Other trials in Spain

Turkey (Türkiye)10 sites

  • Investigational Site Number : 7920010

    Ankara, 06560

  • Investigational Site Number : 7920001

    Antalya, 07070

  • Investigational Site Number : 7920008

    Gaziantep, 27310

  • Investigational Site Number : 7920003

    Istanbul, 34010

  • Investigational Site Number : 7920005

    Istanbul, 34093

  • Investigational Site Number : 7920006

    Istanbul, 34093

  • Investigational Site Number : 7920002

    Istanbul, 34098

  • Investigational Site Number : 7920009

    Istanbul, 34662

  • Investigational Site Number : 7920004

    Kayseri, 38039

  • Investigational Site Number : 7920007

    Samsun, 55139

Other trials in Turkey (Türkiye)

Brazil9 sites

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

    Curitiba, Paraná, 80230-130

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

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Ribeirão Preto, São Paulo, 14049-900

  • 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, 09060-650

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

    São Paulo, 01323-020

  • Hospital das Clinicas FMUSP- Site Number : 0760012

    São Paulo, 05403-000

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

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

France8 sites

  • Investigational Site Number : 2500011

    Bordeaux, 33000

  • Investigational Site Number : 2500009

    Nantes, 44093

  • Investigational Site Number : 2500013

    Nice, 06202

  • Investigational Site Number : 2500006

    Pierre-Bénite, 69495

  • Investigational Site Number : 2500010

    Romans-sur-Isère, 26102

  • Investigational Site Number : 2500012

    Rouen, 76031

  • Investigational Site Number : 2500016

    Saint-Pierre, 97410

  • Investigational Site Number : 2500002

    Toulouse, 31059

Other trials in France

Czechia7 sites

  • Investigational Site Number : 2032105

    Nový Jičín, 741 01

  • Investigational Site Number : 2030010

    Olomouc, 779 00

  • Investigational Site Number : 2032104

    Ostrava, 702 00

  • Investigational Site Number : 2030009

    Pilsen, 323 00

  • Investigational Site Number : 2030008

    Prague, 110 00

  • Investigational Site Number : 2030008

    Prague, 110 01

  • Investigational Site Number : 2030011

    Prague, 150 00

Other trials in Czechia

Italy5 sites

  • Investigational Site Number : 3800012

    Bologna, 40138

  • Investigational Site Number : 3800011

    L’Aquila, 67100

  • Investigational Site Number : 3800003

    Milan, Lombardy, 20122

  • Investigational Site Number : 3800008

    Pisa, 56126

  • Investigational Site Number : 3800019

    Torette, 60020

Other trials in Italy

Bulgaria4 sites

  • Investigational Site Number : 1002007

    Dupnitsa, 2600

  • Investigational Site Number : 1002004

    Pleven, 5800

  • Investigational Site Number : 1002009

    Sofia, 1431

  • Investigational Site Number : 1002006

    Sofia, 1592

Other trials in Bulgaria

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 on Background Topical Corticosteroids

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI).

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI.

Read more

Study details include:

At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).

For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.

For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period.

The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

Being tested
Amlitelimab, Placebo, Topical corticosteroids, Topical calcineurin inhibitors
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: SC injection

  • PlaceboDrug

    Pharmaceutical form: injection solution Route of administration: SC injection

  • Topical corticosteroidsDrug

    Pharmaceutical form: Topical formulation Route of administration: Topical

  • Topical calcineurin inhibitorsDrug

    Pharmaceutical form: Topical formulation Route of administration: Topical

Study groups in NCT06224348
Study groupRoleWhat they receive
Amlitelimab dose 1ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors
Amlitelimab dose 2ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors
PlaceboPlacebo comparatorSubcutaneous injection as per protocol
Receives: Drug: Placebo; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors

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 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).

    Measured: Week 24

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

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

    Measured: Week 24

  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 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).

    Measured: Week 24

Secondary outcomes (39)

  1. Proportion of participants reaching EASI-75 at Week 24 (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 24

  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 24

  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 24

  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 20

  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 20

  6. 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: Week 24

  7. 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 24

  8. 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 24

  9. Proportion of participants with PP-NRS 0 or 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 2

  10. 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 24

  11. 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 24

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

    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 24

  13. 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 24

  14. 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 24

  15. 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 24

  16. 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 24

  17. 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 24

  18. 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 24

  19. 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 24

  20. 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 24

  21. 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 24

  22. Percent change in weekly average of daily 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 24

  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 24

  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 24

  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 24

  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 24

  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 24

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

    Measured: Baseline to Week 24

  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 24

  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 24

  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 24

  32. Change in Patient Oriented Eczema Measure (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 24

  33. Proportion of participants with a reduction in 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 24

  34. Proportion of participants with rescue medication use

    Measured: Baseline to Week 24

  35. Cumulative amount of topical corticosteroids (TCS) consumption

    Measured: Baseline to Week 24

  36. Percentage of TCS/topical calcineurin inhibitors (TCI) free days

    Measured: Baseline to Week 24

  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 40

  38. Serum amlitelimab concentrations

    Measured: Baseline to Week 40

  39. Incidence of antidrug antibodies (ADAs) of amlitelimab

    Measured: Baseline to Week 40

Timeline

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

  1. First posted25 Jan 2024
  2. Study start18 Jan 2024
  3. Primary completion21 Aug 2025
  4. Study completion1 Nov 2025

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
643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06224348
Sponsor's protocol ID
EFC17561
Other IDs
2023-506558-20-00, U1111-1275-9760, 2023-506558-20, 2023
Acronym
SHORE
Status last verified
Aug 2026
First submitted
16 Jan 2024
Last updated
13 Aug 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 calcineurin inhibitors in people with Dermatitis Atopic, run by Sanofi at 167 sites in 14 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: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Japan, Canada, China, Argentina and 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 24 (time frame: Week 24). 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 NCT06224348.

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 Aug 2026.

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