AzTrials
AzTrials

Dermatitis AtopicPhase 3NCT06181435

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

A Phase 3 study testing Amlitelimab in people with Dermatitis Atopic, run by Sanofi at 142 sites in 16 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 monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those… 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
589 participants
Where
142 sitesin 16 countries
Study dates
21 Dec 2023to 12 Mar 2026
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 either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
  • v-IGA-AD of 3 or 4 at baseline visit
  • EASI score of 16 or higher at baseline
  • AD involvement of 10% or more of BSA at baseline
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 patient's potential participation in a clinical trial.

Trial locations and contacts

142 sites in 16 countries.

142 sites in 16 countries

United States43 sites

  • University of New Mexico Comprehensive Cancer Center- Site Number : 8401263

    Albuquerque, New Mexico, 87102

  • Arlington Research Center- Site Number : 8401248

    Arlington, Texas, 76011

  • Care Access - Arlington- Site Number : 8401134

    Arlington, Virginia, 22206

  • Bexley Dermatology Research- Site Number : 8401051

    Bexley, Ohio, 43209

  • Tufts Medical Center Site Number : 8401201

    Boston, Massachusetts, 02111

  • Access Dermatology- Site Number : 8401296

    Bowling Green, Kentucky, 42104

  • OmeraNY- Site Number : 8401156

    Brooklyn, New York, 11220

  • Velocity Clinical Research - Springdale- Site Number : 8401153

    Cincinnati, Ohio, 45246

  • Columbia Dermatology & Aesthetics- Site Number : 8401166

    Columbia, South Carolina, 29212

  • AllerVie Clinical Research - Columbus- Site Number : 8401104

    Columbus, Georgia, 31904

  • Pediatric Skin Research- Site Number : 8401198

    Coral Gables, Florida, 33146

  • MedPharmics - Covington- Site Number : 8401137

    Covington, Louisiana, 70433

  • Derm Texas- Site Number : 8401217

    Dallas, Texas, 75235

  • Red River Research Partners- Site Number : 8401196

    Fargo, North Dakota, 58103

  • University of Connecticut Health Center- Site Number : 8401115

    Farmington, Connecticut, 06032

  • First Georgia Physician Group- Site Number : 8401190

    Fayetteville, Georgia, 30214

  • Velocity Clinical Research - Hampton- Site Number : 8401154

    Hampton, Virginia, 23666

  • Care Access - Hoboken- Site Number : 8401132

    Hoboken, New Jersey, 07030

  • Skin Care Research - Hollywood- Site Number : 8401071

    Hollywood, Florida, 33021

  • Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063

    Houston, Texas, 77004

  • Prolato Clinical Research Center- Site Number : 8401209

    Houston, Texas, 77054

  • University Of Mississippi Medical Center- Site Number : 8401184

    Jackson, Mississippi, 39216

  • Torrance Clinical Research- Site Number : 8401027

    Lomita, California, 90717

  • Dermatology Research Associates - Los Angeles- Site Number : 8401092

    Los Angeles, California, 90045

  • Care Access Research - Marriottsville- Site Number : 8401126

    Marriottsville, Maryland, 21104

  • Savin Medical Group - Miami- Site Number : 8401085

    Miami, Florida, 33126

  • Anchor Medical Research- Site Number : 8401300

    Miami, Florida, 33176

  • Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079

    Mission Viejo, California, 92691

  • Sienna Dermatology- Site Number : 8401148

    Missouri City, Texas, 77459

  • Equity Medical- Site Number : 8401239

    New York, New York, 10023

  • Advanced Research Institute - Odgen- Site Number : 8401057

    Ogden, Utah, 84405

  • Accel Research - Nona Pediatric Center- Site Number : 8401081

    Orlando, Florida, 32829

  • Cura Clinical Research - Oxnard- Site Number : 8401142

    Oxnard, California, 93030

  • Dermatology Associates of Plymouth Meeting- Site Number : 8401147

    Plymouth Meeting, Pennsylvania, 19462

  • Nuline Clinical Trial Center- Site Number : 8401161

    Pompano Beach, Florida, 33060

  • Health Concepts- Site Number : 8401059

    Rapid City, South Dakota, 57702

  • Progressive Clinical Research - San Antonio- Site Number : 8401016

    San Antonio, Texas, 78229

  • Clinical Science Institute- Site Number : 8401028

    Santa Monica, California, 90404

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

    Scottsdale, Arizona, 85260

  • Clinical Research Trials of Florida- Site Number : 8401023

    Tampa, Florida, 33607

  • Montefiore Medical Center - Moses Campus- Site Number : 8401150

    The Bronx, New York, 10467

  • Eclipse Clinical Research- Site Number : 8401158

    Tucson, Arizona, 85745

  • PEAK Research- Site Number : 8401083

    Upper Saint Clair, Pennsylvania, 15241

Other trials in United States

Japan18 sites

  • Investigational Site Number : 3920009

    Chitose, Hokkaido, 066-0021

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0031

  • Investigational Site Number : 3923109

    Habikino, Osaka, 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

Other trials in Japan

China16 sites

  • Investigational Site Number : 1560004

    Beijing, 100191

  • Investigational Site Number : 1560030

    Beijing, 100730

  • Investigational Site Number : 1560022

    Chengdu, 610041

  • Investigational Site Number : 1560021

    Guangzhou, 510018

  • Investigational Site Number : 1560025

    Guangzhou, 510080

  • Investigational Site Number : 1560002

    Hangzhou, 310006

  • Investigational Site Number : 1560006

    Hangzhou, 310009

  • Investigational Site Number : 1560029

    Hangzhou, 310014

  • Investigational Site Number : 1560007

    Jinan, 250013

  • Investigational Site Number : 1560024

    Ningbo, 315010

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560005

    Shanghai, 200443

  • Investigational Site Number : 1560026

    Shenyang, 110179

  • Investigational Site Number : 1560023

    Wenzhou, 325035

  • Investigational Site Number : 1560003

    Wuxi, 214000

  • Investigational Site Number : 1560028

    Zhenjiang, 212000

Other trials in China

Argentina9 sites

  • Investigational Site Number : 0320021

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320016

    Buenos Aires, 1055

  • Investigational Site Number : 0320001

    Buenos Aires, 1121

  • Investigational Site Number : 0320002

    Buenos Aires, 1425

  • Investigational Site Number : 0320009

    Buenos Aires, 1425

  • Investigational Site Number : 0320017

    Pilar, Buenos Aires, 1629

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320015

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

South Africa8 sites

  • Investigational Site Number : 7100004

    Boksburg, 1459

  • Investigational Site Number : 7100010

    Cape Town, 7533

  • Investigational Site Number : 7100009

    Cape Town, 7708

  • Investigational Site Number : 7100012

    Durban, 3630

  • Investigational Site Number : 7100001

    Durban, 4058

  • Investigational Site Number : 7100015

    Johannesburg, 1500

  • Investigational Site Number : 7100007

    Johannesburg, 2196

  • Investigational Site Number : 7100003

    Pretoria, 0009

Other trials in South Africa

Turkey (Türkiye)7 sites

  • Investigational Site Number : 7920001

    Antalya, 07070

  • Investigational Site Number : 7920005

    Istanbul, 34093

  • Investigational Site Number : 7920006

    Istanbul, 34093

  • Investigational Site Number : 7920002

    Istanbul, 34098

  • Investigational Site Number : 7920004

    Kayseri, 38039

  • Investigational Site Number : 7920011

    Mersin, 33343

  • Investigational Site Number : 7920007

    Samsun, 55139

Other trials in Turkey (Türkiye)

Chile5 sites

  • Investigational Site Number : 1520015

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520013

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520014

    Santiago, Reg Metropolitana de Santiago, 7750495

  • Investigational Site Number : 1520004

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Czechia5 sites

  • Investigational Site Number : 2032106

    Kutná Hora, 284 01

  • Investigational Site Number : 2030010

    Olomouc, 779 00

  • Investigational Site Number : 2032104

    Ostrava, 702 00

  • Investigational Site Number : 2030011

    Prague, 150 00

  • Investigational Site Number : 2030006

    Prague, 160 00

Other trials in Czechia

Italy5 sites

  • Investigational Site Number : 3800009

    Catania, 95123

  • Investigational Site Number : 3800008

    Pisa, 56126

  • Investigational Site Number : 3800013

    Rome, Roma, 00133

  • Investigational Site Number : 3800018

    Rozzano, Milano, 20089

  • Investigational Site Number : 3800022

    Vicenza, 36100

Other trials in Italy

Mexico5 sites

  • Investigational Site Number : 4840012

    Aguascalientes, 20127

  • Investigational Site Number : 4840009

    Durango, 34000

  • Investigational Site Number : 4840011

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4840005

    Monterrey, Nuevo León, 64718

  • Investigational Site Number : 4840003

    Veracruz, 91900

Other trials in Mexico

United Kingdom5 sites

  • Investigational Site Number : 8260006

    Glasgow, G3 8SJ

  • Investigational Site Number : 8260004

    Leicester, LE2 0TA

  • Investigational Site Number : 8262602

    London, London, City of, SE1 7EH

  • Investigational Site Number : 8262601

    London, London, City of, SE1 9RT

  • Investigational Site Number : 8260003

    Portsmouth, Hampshire, PO3 6DW

Other trials in United Kingdom

Portugal4 sites

  • Investigational Site Number : 6200005

    Lisbon, 1169-050

  • Investigational Site Number : 6200004

    Lisbon, 1649-035

  • Investigational Site Number : 6200001

    Lisbon, 1998-018

  • Investigational Site Number : 6200003

    Porto, 4099-001

Other trials in Portugal

Spain4 sites

  • Investigational Site Number : 7240018

    Granada, 18014

  • Investigational Site Number : 7240012

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7240029

    Madrid, 28007

  • Investigational Site Number : 7242503

    Madrid, 28046

Other trials in Spain

Bulgaria3 sites

  • Investigational Site Number : 1002008

    Gabrovo, 5300

  • Investigational Site Number : 1002004

    Pleven, 5800

  • Investigational Site Number : 1002005

    Sofia, 1431

Other trials in Bulgaria

Denmark3 sites

  • Investigational Site Number : 2080002

    Aalborg, 9000

  • Investigational Site Number : 2080001

    Aarhus, 8200

  • Investigational Site Number : 2080003

    Herlev, 2730

Other trials in Denmark

Sweden2 sites

  • Investigational Site Number : 7520006

    Älvsjö, 125 44

  • Investigational Site Number : 7520001

    Örebro, 701 85

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older.

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
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

Study groups in NCT06181435
Study groupRoleWhat they receive
Amlitelimab dose 1ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab
Amlitelimab dose 2ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab
PlaceboPlacebo comparatorSubcutaneous injection as per protocol
Receives: Drug: Placebo

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 (37)

  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 24

  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. Percentage of participants who experience Treatment-Emergent Adverse Events (TEAEs), experience Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment- Emergent Adverse Events of Special Interest (AESI)

    Measured: Baseline to Week 40

  36. Serum amlitelimab concentrations

    Measured: Baseline to Week 40

  37. 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 posted26 Dec 2023
  2. Study start21 Dec 2023
  3. Primary completion25 Nov 2025
  4. Study completion12 Mar 2026

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
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06181435
Sponsor's protocol ID
EFC17560
Other IDs
2023-506557-38, U1111-1275-9665, 2023
Status last verified
Aug 2026
First submitted
13 Dec 2023
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 in people with Dermatitis Atopic, run by Sanofi at 142 sites in 16 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 142 sites in United States, Japan, China, Argentina, South Africa and 11 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 NCT06181435.

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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