AzTrials
AzTrials

Dermatitis AtopicPhase 2ATLANTISNCT05769777

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing Amlitelimab in people with Dermatitis Atopic, run by Sanofi at 174 sites in 25 countries.

Active, not recruiting

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

Official record
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Trial summary

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. 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?
No, everyone receives an active treatment
How many people
999 participants
Where
174 sitesin 25 countries
Study dates
3 Apr 2023to 11 Jun 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
  • Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
  • Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit).
  • Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
  • Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
  • AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
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  • Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
  • Able and willing to comply with requested study visits and procedures.
  • Body weight must be greater than or equal to 25 kg.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.

Who cannot join

  • Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
  • Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  • Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline).
  • History of solid organ or stem cell transplant.
  • Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
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  • Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
  • 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); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
  • Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
  • Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
  • Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening.
  • In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit.
  • In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
  • History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

174 sites in 25 countries.

174 sites in 25 countries

United States22 sites

  • Advanced Medical Research - Atlanta- Site Number : 8400044

    Atlanta, Georgia, 30342

  • Children's Hospital Colorado - Aurora- Site Number : 8400041

    Aurora, Colorado, 80045

  • Allervie Clinical Research - Birmingham- Site Number : 8400050

    Birmingham, Alabama, 35209

  • Dermatology Trial Associates- Site Number : 8400027

    Bryant, Arkansas, 72022

  • Private Practice - Dr. Marthe N. Dika- Site Number : 8400022

    Burlington, Wisconsin, 53105

  • The Derm Institute of West Michigan- Site Number : 8400043

    Caledonia, Michigan, 49316

  • Renaissance Research and Medical Group- Site Number : 8400006

    Cape Coral, Florida, 33991

  • IMMUNOe International Research Centers - Centennial- Site Number : 8400024

    Centennial, Colorado, 80112

  • Research Solutions of Arizona- Site Number : 8400020

    Litchfield Park, Arizona, 85340

  • Michigan Dermatology Institute - Livonia- Site Number : 8401010

    Livonia, Michigan, 48152

  • Florida Pharmaceutical Research and Associates- Site Number : 8400018

    Miami, Florida, 33143

  • Miami Clinical Research Tower- Site Number : 8400036

    Miami, Florida, 33155

  • Florida Research Center- Site Number : 8400011

    Miami, Florida, 33174

  • Kentucky Advanced Medical Research- Site Number : 8400014

    Murray, Kentucky, 42071

  • University Dermatology Trials- Site Number : 8400052

    Newport Beach, California, 92660

  • Sneeze Wheeze & Itch Associates- Site Number : 8400002

    Normal, Illinois, 61761

  • The Children's Hospital of Philadelphia- Site Number : 8400009

    Philadelphia, Pennsylvania, 19104

  • Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053

    San Antonio, Texas, 78218

  • Georgia Skin & Cancer Clinic- Site Number : 8400048

    Savannah, Georgia, 31419

  • Clinical Research Trials of Florida- Site Number : 8400054

    Tampa, Florida, 33607

  • Dermatology Research Center of Oklahoma- Site Number : 8400035

    Tulsa, Oklahoma, 74132

  • Michigan Dermatology Institute - Waterford- Site Number : 8400010

    Waterford, Michigan, 48328

Other trials in United States

China16 sites

  • Investigational Site Number : 1560015

    Beijing, 100045

  • Investigational Site Number : 1560008

    Changchun, 130041

  • Investigational Site Number : 1560016

    Changsha, 410007

  • Investigational Site Number : 1560014

    Chengdu, 610017

  • Investigational Site Number : 1560072

    Fuzhou, 350001

  • Investigational Site Number : 1560074

    Guangzhou, 510120

  • Investigational Site Number : 1560044

    Hangzhou, 310003

  • Investigational Site Number : 1560013

    Jingzhou, 434020

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560018

    Suzhou, 215006

  • Investigational Site Number : 1560010

    Taiyuan, 030001

  • Investigational Site Number : 1560073

    Taizhou, 318000

  • Investigational Site Number : 1560019

    Xinxiang, 453100

  • Investigational Site Number : 1560012

    Yinchuan, 750004

  • Investigational Site Number : 1560011

    Yiwu, 322000

  • Investigational Site Number : 1560028

    Zhenjiang, 212000

Other trials in China

Canada12 sites

  • Investigational Site Number : 1240001

    Calgary, Alberta, T2G 1B1

  • Investigational Site Number : 1240009

    Etobicoke, Ontario, M8X 1Y9

  • Investigational Site Number : 1240008

    Mississauga, Ontario, L5H 1G9

  • Investigational Site Number : 1240002

    Montreal, Quebec, H3G 2S6

  • Investigational Site Number : 1240011

    Oakville, Ontario, L6J 7W5

  • Investigational Site Number : 1240004

    Peterborough, Ontario, K9J 5K2

  • Investigational Site Number : 1240010

    Québec, Quebec, G1V 4X7

  • Investigational Site Number : 1240006

    Québec, Quebec, G1W 4R4

  • Investigational Site Number : 1240003

    Richmond Hill, Ontario, L4B 1L1

  • Investigational Site Number : 1240044

    Saskatoon, Saskatchewan, S7T 0G3

  • Investigational Site Number : 1240012

    Toronto, Ontario, M3H 5Y8

  • Investigational Site Number : 1240051

    Vancouver, British Columbia, V6t 2b5

Other trials in Canada

South Africa12 sites

  • Investigational Site Number : 7100004

    Boksburg, 1459

  • Investigational Site Number : 7100011

    Cape Town, 7530

  • Investigational Site Number : 7100010

    Cape Town, 7533

  • Investigational Site Number : 7100002

    Cape Town, 7700

  • Investigational Site Number : 7100009

    Cape Town, 7708

  • Investigational Site Number : 7100012

    Durban, 3630

  • Investigational Site Number : 7100015

    Durban, 4058

  • Investigational Site Number : 7100007

    Johannesburg, 2196

  • Investigational Site Number : 7100006

    Kempton Park, 1619

  • Investigational Site Number : 7100005

    Middelburg, 1055

  • Investigational Site Number : 7100003

    Pretoria, 0009

  • Investigational Site Number : 7100014

    Pretoria, 0157

Other trials in South Africa

Chile11 sites

  • Investigational Site Number : 1520014

    Chillan, 3800761

  • Investigational Site Number : 1520013

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236

  • Investigational Site Number : 1520009

    Osorno, Los Lagos Region, 5311523

  • Investigational Site Number : 1520011

    Santiago, Reg Metropolitana de Santiago, 7500505

  • 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 : 1520010

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8380465

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383

  • Investigational Site Number : 1520004

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Argentina10 sites

  • Investigational Site Number : 0320008

    Buenos Aires, 1023

  • Investigational Site Number : 0320001

    Buenos Aires, 1121

  • Investigational Site Number : 0320003

    Buenos Aires, 1181

  • Investigational Site Number : 0320002

    Buenos Aires, 1425

  • Investigational Site Number : 0320004

    Buenos Aires, 1425

  • Investigational Site Number : 0320009

    Buenos Aires, 1425

  • Investigational Site Number : 0320005

    Buenos Aires, 1427

  • Investigational Site Number : 0320022

    General Pico, La Pampa Province, 6360

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Brazil9 sites

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

    Curitiba, Paraná, 80060-900

  • Pontifica Universidade Catolica do Parana- Site Number : 0760023

    Curitiba, Paraná, 80215-901

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

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008

    Ribeirão Preto, São Paulo, 14049-900

  • IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004

    Rio de Janeiro, 22470-220

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

    Salvador, Estado de Bahia, 41820-020

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, São Paulo, 09060-650

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003

    São José do Rio Preto, São Paulo, 15090-000

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Germany8 sites

  • Investigational Site Number : 2760020

    Augsburg, 86150

  • Investigational Site Number : 2760009

    Bad Bentheim, 48455

  • Investigational Site Number : 2762203

    Berlin, 10117

  • Investigational Site Number : 2762205

    Dresden, 01307

  • Investigational Site Number : 2762201

    Münster, 48149

  • Investigational Site Number : 2760010

    Osnabrück, 49074

  • Investigational Site Number : 2760021

    Rostock, 18055

  • Investigational Site Number : 2760019

    Witten, 58453

Other trials in Germany

Poland8 sites

  • Investigational Site Number : 6160001

    Chorzów, Silesian Voivodeship, 41-500

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611

  • Investigational Site Number : 6160014

    Lodz, Lódzkie, 90-436

  • Investigational Site Number : 6160012

    Lublin, Lublin Voivodeship, 20-573

  • Investigational Site Number : 6162411

    Warsaw, Masovian Voivodeship, 01-142

  • Investigational Site Number : 6160009

    Warsaw, Masovian Voivodeship, 02-625

  • Investigational Site Number : 6160007

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

France7 sites

  • Investigational Site Number : 2500004

    Créteil, 94010

  • Investigational Site Number : 2500001

    Lille, 59037

  • Investigational Site Number : 2500005

    Marseille, 13885

  • Investigational Site Number : 2500009

    Nantes, 44093

  • Investigational Site Number : 2500003

    Paris, 75010

  • Investigational Site Number : 2500006

    Pierre-Bénite, 69495

  • Investigational Site Number : 2500002

    Toulouse, 31059

Other trials in France

India7 sites

  • Investigational Site Number : 3560006

    Bengaluru, 560004

  • Investigational Site Number : 3560007

    Bikaner, 334001

  • Investigational Site Number : 3560011

    Kochi, 682040

  • Investigational Site Number : 3560005

    Kolkata, 700073

  • Investigational Site Number : 3560004

    Mangaluru, 575002

  • Investigational Site Number : 3560002

    Nashik, 422101

  • Investigational Site Number : 3560008

    Surat, 395002

Other trials in India

Italy7 sites

  • Investigational Site Number : 3800005

    Brescia, 25123

  • Investigational Site Number : 3800003

    Milan, Milano, 20122

  • Investigational Site Number : 3800002

    Naples, Napoli, 80131

  • Investigational Site Number : 3800004

    Naples, Napoli, 80138

  • Investigational Site Number : 3800007

    Rome, Roma, 00161

  • Investigational Site Number : 3800006

    Rome, Roma, 00168

  • Investigational Site Number : 3800008

    Vicenza, 36100

Other trials in Italy

Taiwan7 sites

  • Investigational Site Number : 1580006

    Hsinchu, 300

  • Investigational Site Number : 1583201

    Kaohsiung City, 833

  • Investigational Site Number : 1580002

    New Taipei City, 235

  • Investigational Site Number : 1583202

    Taichung, 402

  • Investigational Site Number : 1580007

    Taichung, 404

  • Investigational Site Number : 1580001

    Taipei, 100

  • Investigational Site Number : 1583203

    Taoyuan City, 333

Other trials in Taiwan

Czechia6 sites

  • Investigational Site Number : 2032105

    Nový Jičín, 741 01

  • Investigational Site Number : 2032104

    Ostrava, 702 00

  • Investigational Site Number : 2032102

    Prague, 100 00

  • Investigational Site Number : 2030003

    Prague, 100 34

  • Investigational Site Number : 2030006

    Prague, 160 00

  • Investigational Site Number : 2030007

    Prague, 180 81

Other trials in Czechia

South Korea6 sites

  • Investigational Site Number : 4100002

    Ansan-si, Gyeonggi-do, 15355

  • Investigational Site Number : 4100016

    Bucheon-si, Gyeonggi-do, 14584

  • Investigational Site Number : 4100018

    Incheon, Incheon-gwangyeoksi, 21565

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 07441

  • Investigational Site Number : 4100003

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Spain6 sites

  • Investigational Site Number : 7242505

    Alicante, 03010

  • Investigational Site Number : 7240002

    Badalona, Barcelona [Barcelona], 08916

  • Investigational Site Number : 7242501

    Córdoba, 14004

  • Investigational Site Number : 7242503

    Madrid, 28046

  • Investigational Site Number : 7240022

    Sabadell, Barcelona [Barcelona], 08208

  • Investigational Site Number : 7240006

    Valencia, 46026

Other trials in Spain

Japan5 sites

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293

  • Investigational Site Number : 3923114

    Obihiro, Hokkaido, 080-0013

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825

Other trials in Japan

United Kingdom4 sites

  • Investigational Site Number : 8260002

    Edinburgh, EH8 9YL

  • Investigational Site Number : 8260001

    London, England, NW3 2QG

  • Investigational Site Number : 8262601

    London, London, City of, SE1 9RT

  • Investigational Site Number : 8260004

    Sheffield, S10 2TH

Other trials in United Kingdom

Netherlands3 sites

  • Investigational Site Number : 5280002

    Breda, 4818 CK

  • Investigational Site Number : 5280004

    Rotterdam, 3015 CE

  • Investigational Site Number : 5280001

    Utrecht, 3584 CX

Other trials in Netherlands

Australia2 sites

  • Investigational Site Number : 0360002

    Kogarah, New South Wales, 2217

  • Investigational Site Number : 0360001

    Sydney, New South Wales, 2010

Other trials in Australia

Mexico2 sites

  • Investigational Site Number : 4840001

    Chihuahua City, 31000

  • Investigational Site Number : 4840008

    Durango, 34000

Other trials in Mexico

Denmark1 site

  • Investigational Site Number : 2080001

    Aarhus, 8200

Other trials in Denmark

Puerto Rico1 site

  • Caribbean Medical Research Center- Site Number : 8400028

    San Juan, 00918

Other trials in Puerto Rico

Switzerland1 site

  • Investigational Site Number : 7560002

    Buochs, 6374

Other trials in Switzerland

Turkey (Türkiye)1 site

  • Investigational Site Number : 7920005

    Manisa, 45030

Other trials in Turkey (Türkiye)

About this study

Official title: An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD).

The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD.

The study duration per participant will be up to 284 weeks, including:

  • A screening period of up to 2 to 4 weeks
  • An open label treatment period of up to 268 weeks (approximately 5 years)
  • A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264)

The planned number of visits will be 35 visits.

Being tested
Amlitelimab
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

    Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Study groups in NCT05769777
Study groupRoleWhat they receive
AmlitelimabExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab

What is being measured

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

  1. Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs)

    Percentage of participants who experienced TEAEs from baseline during the study

    Measured: Baseline up to end of study (EOS) (Week 284)

  2. Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)

    Percentage of participants who experienced TESAEs from baseline during the study

    Measured: Baseline up to EOS (Week 284)

Secondary outcomes (40)

  1. Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI)

    Percentage of participants who experienced AESI from baseline during the study

    Measured: Baseline up to EOS (Week 284)

  2. Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG)

    Measured: Baseline up to EOS (Week 284)

  3. Percentage of participants discontinued from study treatment due to Adverse Events (AEs)

    Measured: Baseline up to EOS (Week 284)

  4. Percent change from baseline in Eczema Area and Severity Index (EASI) score

    The EASI is an Investigator-assessed tool used to measure the extent (area) and severity of AD. The severity is assessed based on 4 disease characteristics (erythema, induration/papulation, excoriation and lichenification). The extent of involvement of AD is assessed in 4 body regions (head/neck, trunk, upper extremities and lower extremities). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Measured: Baseline to EOS (Week 284)

  5. Proportion of participants with at least a 75% reduction from baseline in the EASI (EASI-75)

    Measured: Baseline to EOS (Week 284)

  6. Proportion of participants with at least a 50% reduction from baseline in the EASI (EASI-50)

    Measured: Baseline to EOS (Week 284)

  7. Proportion of participants with at least a 90% reduction from baseline in the EASI (EASI-90)

    Measured: Baseline to EOS (Week 284)

  8. Proportion of participants with at least 100% reduction from baseline in the EASI (EASI-100)

    Measured: Baseline to EOS (Week 284)

  9. Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline

    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 EOS (Week 284)

  10. 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 EOS (Week 284)

  11. Proportion of participants with vIGA-AD of 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: Baseline to EOS (Week 284)

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

    BSA affected by AD will measure the extent (area) of the disease.

    Measured: Baseline to EOS (Week 284)

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

    The SCORAD Index is a clinical tool used to standardise the evaluation of the extent and severity of AD. To determine the extent of AD, the affected area (A) as a percentage of the whole body is determined, with a maximum score of 100%. The severity (B) of 6 specific symptoms of AD (redness, swelling, oozing/crusting, scratch marks, skin thickening [lichenification], dryness [area where there is no inflammation]) is assessed on a 4-point scale, with a maximum score of 18: none (0), mild (1), moderate (2) or severe (3). Subjective symptoms (C): itch and sleeplessness are recorded as scored by the participants or relative on a visual analogue scale (VAS), where 0 = no itch (or sleeplessness) and 10 = worst imaginable itch (or sleeplessness), with a maximum possible score of 20.

    Measured: Baseline to EOS (Week 284)

  14. Proportion of participants requiring rescue treatment at each visit

    Measured: Baseline to EOS (Week 284)

  15. 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 single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.

    Measured: Baseline to EOS (Week 284)

  16. Proportion of participants with PP-NRS 0 or 1

    The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.

    Measured: Baseline to EOS (Week 284)

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

    The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.

    Measured: Baseline to EOS (Week 284)

  18. 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 during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.

    Measured: Baseline to EOS (Week 284)

  19. 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 during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.

    Measured: Baseline to EOS (Week 284)

  20. 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 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis".

    Measured: Baseline to EOS (Week 284)

  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 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis".

    Measured: Baseline to EOS (Week 284)

  22. Change in Patient Oriented Eczema Measure (POEM) from baseline

    The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.

    Measured: Baseline to EOS (Week 284)

  23. 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 used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.

    Measured: Baseline to EOS (Week 284)

  24. Proportion of adolescent participants with a reduction in POEM ≥6 from Baseline in adolescents with POEM baseline ≥6

    The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.

    Measured: Baseline to EOS (Week 284)

  25. Change in Atopic Dermatitis Control Test (ADCT) from baseline

    The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.

    Measured: Baseline to EOS (Week 284)

  26. Proportion of participants with a reduction in ADCT ≥5 from baseline in participants with baseline ADCT≥7

    The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.

    Measured: Baseline to EOS (Week 284)

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

    The DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL), covering the participant's previous week (i.e. past 7 days). Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.

    Measured: Baseline to EOS (Week 284)

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

    The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to <16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.

    Measured: Baseline to EOS (Week 284)

  29. Proportion of participants with age ≥12 to <16 with a reduction in CDLQI ≥4 from Baseline in participants with age ≥12 to <16 years old with CDLQI at baseline ≥6

    The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to <16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.

    Measured: Baseline to EOS (Week 284)

  30. Proportion of participants with age ≥12 to <16 with a reduction in CDLQI ≥6 from Baseline in participants with age ≥12 to <16 years old with CDLQI at baseline ≥6

    The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to <16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.

    Measured: Baseline to EOS (Week 284)

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

    The DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL), covering the participant's previous week (i.e. past 7 days). Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.

    Measured: Baseline to EOS (Week 284)

  32. Change in Patient Global Impression of Severity (PGIS) from baseline

    The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.

    Measured: Baseline to EOS (Week 284)

  33. Proportions of participants who report symptoms to be "No" on the PGIS score

    The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.

    Measured: Baseline to EOS (Week 284)

  34. Proportions of participants who report symptoms to be "No" or "Mild" on the PGIS score

    The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.

    Measured: Baseline to EOS (Week 284)

  35. Proportion of participants who respond "Much better" on the Patient Global Impression of (PGIC) scale

    The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.

    Measured: Week 16 to EOS (Week 284)

  36. Proportion of participants who respond "Much better" or "A little better" on the PGIC scale

    The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.

    Measured: Week 16 to EOS (Week 284)

  37. Proportion of participants by PGIC responses

    The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.

    Measured: Week 16 to EOS (Week 284)

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

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

    Measured: Baseline to EOS (Week 284)

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

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

    HADS-A is the anxiety HADS subscale.

    Measured: Baseline to EOS (Week 284)

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

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

    HADS-D is the depression HADS subscale.

    Measured: Baseline to EOS (Week 284)

Timeline

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

  1. First posted15 Mar 2023
  2. Study start3 Apr 2023
  3. Primary completion11 Jun 2031 (estimated)
  4. Study completion11 Jun 2031 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
999 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05769777
Sponsor's protocol ID
LTS17789
Other IDs
U1111-1280-6080, 2022-502188-39
Acronym
ATLANTIS
Status last verified
Apr 2026
First submitted
3 Mar 2023
Last updated
23 Apr 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 2 study testing Amlitelimab in people with Dermatitis Atopic, run by Sanofi at 174 sites in 25 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 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in United States, China, Canada, South Africa, Chile and 20 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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

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

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

What does the primary outcome measure?

Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to end of study (EOS) (Week 284)). The study lists 2 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 NCT05769777.

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 23 Apr 2026.

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