AzTrials
AzTrials

Dermatitis AtopicPhase 3COAST 1NCT06130566

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

A Phase 3 study testing Amlitelimab in people with Dermatitis Atopic, run by Sanofi at 148 sites in 15 countries.

Completed

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

Official record
Search all trials

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
601 participants
Where
148 sitesin 15 countries
Study dates
8 Nov 2023to 13 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 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

  • 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 (1 week in the event of superficial skin infections)
  • Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
Show all 11Show fewer
  • 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

148 sites in 15 countries.

148 sites in 15 countries

United States42 sites

  • Massachusetts General Hospital- Site Number : 8401192

    Boston, Massachusetts, 02114

  • Vial Health - DermDox Dermatology- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011

  • Onsite Clinical Solutions - Charlotte - Blakeney Park Drive- Site Number : 8401124

    Charlotte, North Carolina, 28277

  • MedPharmics - Covington- Site Number : 8401137

    Covington, Louisiana, 70433

  • Cleaver Medical Group Dermatology- Site Number : 8401139

    Cumming, Georgia, 30040

  • Dermatology Treatment and Research Center- Site Number : 8401164

    Dallas, Texas, 75230

  • Skin Specialist of Addison- Site Number : 8401208

    Dallas, Texas, 75254

  • Revival Research - Doral- Site Number : 8401012

    Dearborn, Michigan, 33122

  • Henry Ford Hospital- Site Number : 8401044

    Detroit, Michigan, 48202

  • St Jude Clinical Research- Site Number : 8401287

    Doral, Florida, 33172

  • Universal Dermatology- Site Number : 8401224

    Fairport, New York, 14450

  • Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286

    Fort Myers, Florida, 33919

  • First OC Dermatology- Site Number : 8401025

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538

  • Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8401225

    Greenville, South Carolina, 29607

  • Direct Helpers Research Center- Site Number : 8401056

    Hialeah, Florida, 33012

  • Encore Medical Research- Site Number : 8401030

    Hollywood, Florida, 33021

  • Sunwise Clinical Research- Site Number : 8401022

    Lafayette, California, 94549

  • MedPharmics - Lafeyette- Site Number : 8401152

    Lafayette, Louisiana, 70508

  • Somnos Clinical Research- Site Number : 8401203

    Lincoln, Nebraska, 68510

  • Skin Sciences- Site Number : 8401039

    Louisville, Kentucky, 40217

  • Skin Care Physicians of Georgia - Macon- Site Number : 8401034

    Macon, Georgia, 31217

  • Florida International Research Center- Site Number : 8401091

    Miami, Florida, 33173

  • Miami Dermatology and Laser Research- Site Number : 8401086

    Miami, Florida, 33173

  • Metro Boston Clinical Partners- Site Number : 8401128

    Needham, Massachusetts, 02492

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

    New York, New York, 10075

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

    Norfolk, Virginia, 23502

  • Carbon Health - North Hollywood - NoHo West- Site Number : 8401218

    North Hollywood, California, 91606

  • Northridge Clinical Trials - Northridge- Site Number : 8401080

    Northridge, California, 91325

  • Clinical Neuroscience Solutions - Orlando - South Delaney Avenue- Site Number : 8401035

    Orlando, Florida, 32806

  • Paddington Testing Company- Site Number : 8401041

    Philadelphia, Pennsylvania, 19103

  • Clinical Research of Philadelphia- Site Number : 8401193

    Philadelphia, Pennsylvania, 19114

  • Oregon Medical Research Center- Site Number : 8401017

    Portland, Oregon, 97201

  • SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058

    Ridgeland, Mississippi, 39157

  • MediSearch Clinical Trials- Site Number : 8401140

    Saint Joseph, Missouri, 64506

  • Texas Dermatology and Laser Specialists- Site Number : 8401131

    San Antonio, Texas, 78218

  • Scottsdale Clinical Trials- Site Number : 8401149

    Scottsdale, Arizona, 85260

  • Stryde Research - Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas, 76092

  • Springville Dermatology - Springville- Site Number : 8401106

    Springville, Utah, 84663

  • CHEAR Center- Site Number : 8401123

    The Bronx, New York, 10459

  • Javara Research - Thomasville- Site Number : 8401189

    Thomasville, Georgia, 31792

  • Rophe Adult & Pediatric Medicine- Site Number : 8401289

    Union City, Georgia, 30291

Other trials in United States

South Korea13 sites

  • Investigational Site Number : 4100002

    Ansan-si, Gyeonggi-do, 15355

  • Investigational Site Number : 4100015

    Bupyeong-gu, Incheon-gwangyeoksi, 21431

  • Investigational Site Number : 4100008

    Daegu, Daegu, 41944

  • Investigational Site Number : 4100012

    Gwangju, 61453

  • Investigational Site Number : 4100014

    Seongnam-si, Gyeonggi-do, 13620

  • Investigational Site Number : 4100010

    Seoul, Seoul-teukbyeolsi, 01812

  • Investigational Site Number : 4100013

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100011

    Seoul, Seoul-teukbyeolsi, 06591

  • Investigational Site Number : 4100017

    Seoul, Seoul-teukbyeolsi, 07804

  • Investigational Site Number : 4100009

    Suwon, Gyeonggi-do, 16499

  • Investigational Site Number : 4100003

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Canada12 sites

  • Investigational Site Number : 1240033

    Ajax, Ontario, L1S 7K8

  • Investigational Site Number : 1240031

    Edmonton, Alberta, T5K 2V4

  • Investigational Site Number : 1240055

    Hamilton, Ontario, L8S 1G5

  • Investigational Site Number : 1240029

    London, Ontario, N6A 2C2

  • Investigational Site Number : 1241108

    Niagara Falls, Ontario, L2H 1H5

  • Investigational Site Number : 1240034

    Ottawa, Ontario, K1H 7X8

  • Investigational Site Number : 1240028

    Regina, Saskatchewan, S4V 1R9

  • Investigational Site Number : 1240043

    Saint-Jérôme, Quebec, J7Z 7E2

  • Investigational Site Number : 1240036

    Saskatoon, Saskatchewan, S7K 0H6

  • Investigational Site Number : 1240040

    Surrey, British Columbia, V3R 6A7

  • Investigational Site Number : 1240013

    Toronto, Ontario, M3B 3N1

  • Investigational Site Number : 1240035

    Toronto, Ontario, M5A 3R6

Other trials in Canada

Brazil10 sites

  • Hospital São Domingos- Site Number : 0760028

    Bequimão, Maranhão, 65060-645

  • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022

    Curitiba, Paraná, 80060-900

  • 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

  • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018

    Rio de Janeiro, 22241-180

  • 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

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

    São Paulo, 04020-060

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012

    São Paulo, 05403-000

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Chile10 sites

  • Investigational Site Number : 1520009

    Osorno, Reg Metropolitana de Santiago, 5311523

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 7500587

  • 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 : 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 : 1520012

    Talcahuano, 2687000

  • Investigational Site Number : 1520006

    Viña del Mar, Valparaiso, 2530900

Other trials in Chile

Poland9 sites

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611

  • Investigational Site Number : 6162406

    Krakow, 31-209

  • Investigational Site Number : 6160002

    Lodz, 90-265

  • Investigational Site Number : 6160004

    Lublin, 20-607

  • Investigational Site Number : 6160011

    Olsztyn, 11-041

  • Investigational Site Number : 6160010

    Tarnów, 33-100

  • Investigational Site Number : 6160009

    Warsaw, 02-625

  • Investigational Site Number : 6160007

    Warsaw, 02-962

Other trials in Poland

China8 sites

  • Investigational Site Number : 1560042

    Beijing, 100034

  • Investigational Site Number : 1560060

    Chengdu, 610072

  • Investigational Site Number : 1560068

    Chengdu, 610091

  • Investigational Site Number : 1560057

    Chongqing, 400016

  • Investigational Site Number : 1560065

    Chongqing, 400065

  • Investigational Site Number : 1560058

    Guangzhou, 510630

  • Investigational Site Number : 1560059

    Jinan, 250014

  • Investigational Site Number : 1560064

    Shenzhen, 518026

Other trials in China

India8 sites

  • Investigational Site Number : 3560001

    Ahmedabad, 380016

  • Investigational Site Number : 3560005

    Belagavi, 590002

  • Investigational Site Number : 3560008

    Bengaluru, 560090

  • Investigational Site Number : 3560004

    Chandigarh, 160012

  • Investigational Site Number : 3560006

    Haryāna, 121002

  • Investigational Site Number : 3560007

    Kolkata, 700073

  • Investigational Site Number : 3560002

    Nagpur, 440015

  • Investigational Site Number : 3560003

    Pune, 411057

Other trials in India

Germany7 sites

  • Investigational Site Number : 2760009

    Bad Bentheim, 48455

  • Investigational Site Number : 2760014

    Buxtehude, 21614

  • Investigational Site Number : 2760017

    Hamburg, 20095

  • Investigational Site Number : 2762208

    Kiel, 24105

  • Investigational Site Number : 2760018

    Magdeburg, 39104

  • Investigational Site Number : 2760016

    Mainz, 55128

  • Investigational Site Number : 2762201

    Münster, 48149

Other trials in Germany

Israel6 sites

  • Investigational Site Number : 3760004

    Afula, 1834111

  • Investigational Site Number : 3760005

    Beersheba, 8457108

  • Investigational Site Number : 3760001

    Haifa, 3109601

  • Investigational Site Number : 3760003

    Jerusalem, 9112001

  • Investigational Site Number : 3760006

    Petah Tikva, 4920235

  • Investigational Site Number : 3760002

    Petah Tikva, 4941492

Other trials in Israel

Australia5 sites

  • Investigational Site Number : 0360008

    Melbourne, Victoria, 3002

  • Investigational Site Number : 0360006

    Melbourne, Victoria, 3004

  • Investigational Site Number : 0361006

    Traralgon, Victoria, 3844

  • Investigational Site Number : 0360010

    Westmead, New South Wales, 2145

  • Investigational Site Number : 0360007

    Woolloongabba, Queensland, 4102

Other trials in Australia

France5 sites

  • Investigational Site Number : 2500008

    Antony, 92160

  • Investigational Site Number : 2500009

    Nantes, 44093

  • Investigational Site Number : 2500003

    Paris, 75010

  • Investigational Site Number : 2500007

    Reims, 51100

  • Investigational Site Number : 2500010

    Romans-sur-Isère, 26102

Other trials in France

Taiwan5 sites

  • Investigational Site Number : 1583201

    Kaohsiung City, 833

  • Investigational Site Number : 1583202

    Taichung, 402

  • Investigational Site Number : 1580001

    Taipei, 100

  • Investigational Site Number : 1580003

    Taipei

  • Investigational Site Number : 1583203

    Taoyuan City, 333

Other trials in Taiwan

Argentina4 sites

  • Investigational Site Number : 0320023

    Buenos Aires, Buenos Aires F.D., 1028

  • Investigational Site Number : 0320022

    Buenos Aires, 1012

  • Investigational Site Number : 0320010

    Buenos Aires, 1414

  • Investigational Site Number : 0320024

    SAN Miguel de Tucumã¡n, Tucumán Province, T4000

Other trials in Argentina

Greece4 sites

  • Investigational Site Number : 3000004

    Athens, 124 62

  • Investigational Site Number : 3000001

    Athens, 161 21

  • Investigational Site Number : 3000002

    Thessaloniki, 546 42

  • Investigational Site Number : 3000003

    Thessaloniki, 564 29

Other trials in Greece

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 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

    Injection solution SC injection

  • PlaceboDrug

    Injection solution SC injection

Study groups in NCT06130566
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 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

  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 24

  8. 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

  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 24

  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 24

  11. 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

  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 24

  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 24

  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 24

  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 24

  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 24

  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 24

  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 24

  19. Proportion of participants with vIGA-AD 0

    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

  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 24

  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 24

  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 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 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

  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 posted14 Nov 2023
  2. Study start8 Nov 2023
  3. Primary completion23 Jul 2025
  4. Study completion13 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
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06130566
Sponsor's protocol ID
EFC17559
Other IDs
U1111-1275-9715, 2022-501196-41, 2022-501196-41
Acronym
COAST 1
Status last verified
Jul 2026
First submitted
8 Nov 2023
Last updated
22 Jul 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 148 sites in 15 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 11 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, South Korea, Canada, Brazil, Chile and 10 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 NCT06130566.

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 22 Jul 2026.

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