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 (ATLANTIS)

April 22, 2026 updated by: Sanofi

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

999

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320004
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1121
        • Investigational Site Number : 0320001
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320009
      • Buenos Aires, Argentina, 1427
        • Investigational Site Number : 0320005
      • Buenos Aires, Argentina, 1023
        • Investigational Site Number : 0320008
      • Buenos Aires, Argentina, 1181
        • Investigational Site Number : 0320003
    • La Pampa Province
      • General Pico, La Pampa Province, Argentina, 6360
        • Investigational Site Number : 0320022
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320006
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320007
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Investigational Site Number : 0360002
      • Sydney, New South Wales, Australia, 2010
        • Investigational Site Number : 0360001
  • Brazil
      • Rio de Janeiro, Brazil, 22470-220
        • IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41820-020
        • Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022
      • Curitiba, Paraná, Brazil, 80215-901
        • Pontifica Universidade Catolica do Parana- Site Number : 0760023
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008
      • Santo André, São Paulo, Brazil, 09060-650
        • Faculdade de Medicina do ABC- Site Number : 0760001
      • Sorocaba, São Paulo, Brazil, 18040-425
        • Clinica de Alergia Martti Antila- Site Number : 0760006
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Investigational Site Number : 1240001
    • British Columbia
      • Vancouver, British Columbia, Canada, V6t 2b5
        • Investigational Site Number : 1240051
    • Ontario
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Investigational Site Number : 1240009
      • Mississauga, Ontario, Canada, L5H 1G9
        • Investigational Site Number : 1240008
      • Oakville, Ontario, Canada, L6J 7W5
        • Investigational Site Number : 1240011
      • Peterborough, Ontario, Canada, K9J 5K2
        • Investigational Site Number : 1240004
      • Richmond Hill, Ontario, Canada, L4B 1L1
        • Investigational Site Number : 1240003
      • Toronto, Ontario, Canada, M3H 5Y8
        • Investigational Site Number : 1240012
    • Quebec
      • Montreal, Quebec, Canada, H3G 2S6
        • Investigational Site Number : 1240002
      • Québec, Quebec, Canada, G1W 4R4
        • Investigational Site Number : 1240006
      • Québec, Quebec, Canada, G1V 4X7
        • Investigational Site Number : 1240010
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7T 0G3
        • Investigational Site Number : 1240044
  • Chile
      • Chillan, Chile, 3800761
        • Investigational Site Number : 1520014
    • Los Lagos Region
      • Osorno, Los Lagos Region, Chile, 5311523
        • Investigational Site Number : 1520009
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Investigational Site Number : 1520004
    • Reg Metropolitana de Santiago
      • Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
        • Investigational Site Number : 1520013
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500588
        • Investigational Site Number : 1520008
      • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
        • Investigational Site Number : 1520002
      • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 8380465
        • Investigational Site Number : 1520005
      • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 8330034
        • Investigational Site Number : 1520010
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500505
        • Investigational Site Number : 1520011
  • China
      • Beijing, China, 100045
        • Investigational Site Number : 1560015
      • Changchun, China, 130041
        • Investigational Site Number : 1560008
      • Changsha, China, 410007
        • Investigational Site Number : 1560016
      • Chengdu, China, 610017
        • Investigational Site Number : 1560014
      • Fuzhou, China, 350001
        • Investigational Site Number : 1560072
      • Guangzhou, China, 510120
        • Investigational Site Number : 1560074
      • Hangzhou, China, 310003
        • Investigational Site Number : 1560044
      • Jingzhou, China, 434020
        • Investigational Site Number : 1560013
      • Shanghai, China, 200040
        • Investigational Site Number : 1560001
      • Suzhou, China, 215006
        • Investigational Site Number : 1560018
      • Taiyuan, China, 030001
        • Investigational Site Number : 1560010
      • Taizhou, China, 318000
        • Investigational Site Number : 1560073
      • Xinxiang, China, 453100
        • Investigational Site Number : 1560019
      • Yinchuan, China, 750004
        • Investigational Site Number : 1560012
      • Yiwu, China, 322000
        • Investigational Site Number : 1560011
      • Zhenjiang, China, 212000
        • Investigational Site Number : 1560028
  • Czechia
      • Nový Jičín, Czechia, 741 01
        • Investigational Site Number : 2032105
      • Ostrava, Czechia, 702 00
        • Investigational Site Number : 2032104
      • Prague, Czechia, 160 00
        • Investigational Site Number : 2030006
      • Prague, Czechia, 100 00
        • Investigational Site Number : 2032102
      • Prague, Czechia, 100 34
        • Investigational Site Number : 2030003
      • Prague, Czechia, 180 81
        • Investigational Site Number : 2030007
  • Denmark
      • Aarhus, Denmark, 8200
        • Investigational Site Number : 2080001
  • France
      • Créteil, France, 94010
        • Investigational Site Number : 2500004
      • Lille, France, 59037
        • Investigational Site Number : 2500001
      • Marseille, France, 13885
        • Investigational Site Number : 2500005
      • Nantes, France, 44093
        • Investigational Site Number : 2500009
      • Paris, France, 75010
        • Investigational Site Number : 2500003
      • Pierre-Bénite, France, 69495
        • Investigational Site Number : 2500006
      • Toulouse, France, 31059
        • Investigational Site Number : 2500002
  • Germany
      • Augsburg, Germany, 86150
        • Investigational Site Number : 2760020
      • Bad Bentheim, Germany, 48455
        • Investigational Site Number : 2760009
      • Berlin, Germany, 10117
        • Investigational Site Number : 2762203
      • Dresden, Germany, 01307
        • Investigational Site Number : 2762205
      • Münster, Germany, 48149
        • Investigational Site Number : 2762201
      • Osnabrück, Germany, 49074
        • Investigational Site Number : 2760010
      • Rostock, Germany, 18055
        • Investigational Site Number : 2760021
      • Witten, Germany, 58453
        • Investigational Site Number : 2760019
  • India
      • Bengaluru, India, 560004
        • Investigational Site Number : 3560006
      • Bikaner, India, 334001
        • Investigational Site Number : 3560007
      • Kochi, India, 682040
        • Investigational Site Number : 3560011
      • Kolkata, India, 700073
        • Investigational Site Number : 3560005
      • Mangaluru, India, 575002
        • Investigational Site Number : 3560004
      • Nashik, India, 422101
        • Investigational Site Number : 3560002
      • Surat, India, 395002
        • Investigational Site Number : 3560008
  • Italy
      • Brescia, Italy, 25123
        • Investigational Site Number : 3800005
      • Vicenza, Italy, 36100
        • Investigational Site Number : 3800008
    • Milano
      • Milan, Milano, Italy, 20122
        • Investigational Site Number : 3800003
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Investigational Site Number : 3800002
      • Naples, Napoli, Italy, 80138
        • Investigational Site Number : 3800004
    • Roma
      • Rome, Roma, Italy, 00168
        • Investigational Site Number : 3800006
      • Rome, Roma, Italy, 00161
        • Investigational Site Number : 3800007
  • Japan
    • Hokkaido
      • Obihiro, Hokkaido, Japan, 080-0013
        • Investigational Site Number : 3923114
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 221-0825
        • Investigational Site Number : 3923113
    • Osaka
      • Sakai, Osaka, Japan, 593-8324
        • Investigational Site Number : 3923110
    • Tochigi
      • Mibu, Tochigi, Japan, 321-0293
        • Investigational Site Number : 3923106
    • Tokyo
      • Tachikawa, Tokyo, Japan, 190-0023
        • Investigational Site Number : 3920001
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Investigational Site Number : 4840001
      • Durango, Mexico, 34000
        • Investigational Site Number : 4840008
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Investigational Site Number : 5280002
      • Rotterdam, Netherlands, 3015 CE
        • Investigational Site Number : 5280004
      • Utrecht, Netherlands, 3584 CX
        • Investigational Site Number : 5280001
  • Poland
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-573
        • Investigational Site Number : 6160012
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-436
        • Investigational Site Number : 6160014
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-625
        • Investigational Site Number : 6160009
      • Warsaw, Masovian Voivodeship, Poland, 02-962
        • Investigational Site Number : 6160007
      • Warsaw, Masovian Voivodeship, Poland, 01-142
        • Investigational Site Number : 6162411
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Investigational Site Number : 6160006
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Poland, 41-500
        • Investigational Site Number : 6160001
      • Katowice, Silesian Voivodeship, Poland, 40-611
        • Investigational Site Number : 6160003
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Caribbean Medical Research Center- Site Number : 8400028
  • South Africa
      • Boksburg, South Africa, 1459
        • Investigational Site Number : 7100004
      • Cape Town, South Africa, 7700
        • Investigational Site Number : 7100002
      • Cape Town, South Africa, 7533
        • Investigational Site Number : 7100010
      • Cape Town, South Africa, 7708
        • Investigational Site Number : 7100009
      • Cape Town, South Africa, 7530
        • Investigational Site Number : 7100011
      • Durban, South Africa, 3630
        • Investigational Site Number : 7100012
      • Durban, South Africa, 4058
        • Investigational Site Number : 7100015
      • Johannesburg, South Africa, 2196
        • Investigational Site Number : 7100007
      • Kempton Park, South Africa, 1619
        • Investigational Site Number : 7100006
      • Middelburg, South Africa, 1055
        • Investigational Site Number : 7100005
      • Pretoria, South Africa, 0009
        • Investigational Site Number : 7100003
      • Pretoria, South Africa, 0157
        • Investigational Site Number : 7100014
  • South Korea
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Investigational Site Number : 4100002
      • Bucheon-si, Gyeonggi-do, South Korea, 14584
        • Investigational Site Number : 4100016
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Investigational Site Number : 4100003
    • Incheon-gwangyeoksi
      • Incheon, Incheon-gwangyeoksi, South Korea, 21565
        • Investigational Site Number : 4100018
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 05030
        • Investigational Site Number : 4100006
      • Seoul, Seoul-teukbyeolsi, South Korea, 07441
        • Investigational Site Number : 4100001
  • Spain
      • Alicante, Spain, 03010
        • Investigational Site Number : 7242505
      • Córdoba, Spain, 14004
        • Investigational Site Number : 7242501
      • Madrid, Spain, 28046
        • Investigational Site Number : 7242503
      • Valencia, Spain, 46026
        • Investigational Site Number : 7240006
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Investigational Site Number : 7240002
      • Sabadell, Barcelona [Barcelona], Spain, 08208
        • Investigational Site Number : 7240022
  • Switzerland
      • Buochs, Switzerland, 6374
        • Investigational Site Number : 7560002
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Investigational Site Number : 1580006
      • Kaohsiung City, Taiwan, 833
        • Investigational Site Number : 1583201
      • New Taipei City, Taiwan, 235
        • Investigational Site Number : 1580002
      • Taichung, Taiwan, 402
        • Investigational Site Number : 1583202
      • Taichung, Taiwan, 404
        • Investigational Site Number : 1580007
      • Taipei, Taiwan, 100
        • Investigational Site Number : 1580001
      • Taoyuan, Taiwan, 333
        • Investigational Site Number : 1583203
  • Turkey (Türkiye)
      • Manisa, Turkey (Türkiye), 45030
        • Investigational Site Number : 7920005
  • United Kingdom
      • Edinburgh, United Kingdom, EH8 9YL
        • Investigational Site Number : 8260002
      • Sheffield, United Kingdom, S10 2TH
        • Investigational Site Number : 8260004
    • England
      • London, England, United Kingdom, NW3 2QG
        • Investigational Site Number : 8260001
    • London, City of
      • London, London, City of, United Kingdom, SE1 9RT
        • Investigational Site Number : 8262601
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Allervie Clinical Research - Birmingham- Site Number : 8400050
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona- Site Number : 8400020
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates- Site Number : 8400027
    • California
      • Newport Beach, California, United States, 92660
        • University Dermatology Trials- Site Number : 8400052
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado - Aurora- Site Number : 8400041
      • Centennial, Colorado, United States, 80112
        • IMMUNOe International Research Centers - Centennial- Site Number : 8400024
    • Florida
      • Cape Coral, Florida, United States, 33991
        • Renaissance Research and Medical Group- Site Number : 8400006
      • Miami, Florida, United States, 33143
        • Florida Pharmaceutical Research and Associates- Site Number : 8400018
      • Miami, Florida, United States, 33155
        • Miami Clinical Research Tower- Site Number : 8400036
      • Miami, Florida, United States, 33174
        • Florida Research Center- Site Number : 8400011
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida- Site Number : 8400054
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Advanced Medical Research - Atlanta- Site Number : 8400044
      • Savannah, Georgia, United States, 31419
        • Georgia Skin & Cancer Clinic- Site Number : 8400048
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze Wheeze & Itch Associates- Site Number : 8400002
    • Kentucky
      • Murray, Kentucky, United States, 42071
        • Kentucky Advanced Medical Research- Site Number : 8400014
    • Michigan
      • Caledonia, Michigan, United States, 49316
        • The Derm Institute of West Michigan- Site Number : 8400043
      • Livonia, Michigan, United States, 48152
        • Michigan Dermatology Institute - Livonia- Site Number : 8401010
      • Waterford, Michigan, United States, 48328
        • Michigan Dermatology Institute - Waterford- Site Number : 8400010
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74132
        • Dermatology Research Center of Oklahoma- Site Number : 8400035
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia- Site Number : 8400009
    • Texas
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053
    • Wisconsin
      • Burlington, Wisconsin, United States, 53105
        • Private Practice - Dr. Marthe N. Dika- Site Number : 8400022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlitelimab
Subcutaneous injection as per protocol
Drug: Amlitelimab
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline up to end of study (EOS) (Week 284)
Percentage of participants who experienced TEAEs from baseline during the study
Baseline up to end of study (EOS) (Week 284)
Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Baseline up to EOS (Week 284)
Percentage of participants who experienced TESAEs from baseline during the study
Baseline up to EOS (Week 284)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI)
Time Frame: Baseline up to EOS (Week 284)
Percentage of participants who experienced AESI from baseline during the study
Baseline up to EOS (Week 284)
Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG)
Time Frame: Baseline up to EOS (Week 284)
Baseline up to EOS (Week 284)
Percentage of participants discontinued from study treatment due to Adverse Events (AEs)
Time Frame: Baseline up to EOS (Week 284)
Baseline up to EOS (Week 284)
Percent change from baseline in Eczema Area and Severity Index (EASI) score
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants with at least a 75% reduction from baseline in the EASI (EASI-75)
Time Frame: Baseline to EOS (Week 284)
Baseline to EOS (Week 284)
Proportion of participants with at least a 50% reduction from baseline in the EASI (EASI-50)
Time Frame: Baseline to EOS (Week 284)
Baseline to EOS (Week 284)
Proportion of participants with at least a 90% reduction from baseline in the EASI (EASI-90)
Time Frame: Baseline to EOS (Week 284)
Baseline to EOS (Week 284)
Proportion of participants with at least 100% reduction from baseline in the EASI (EASI-100)
Time Frame: Baseline to EOS (Week 284)
Baseline to EOS (Week 284)
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
Time Frame: Baseline to EOS (Week 284)
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).
Baseline to EOS (Week 284)
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
Time Frame: Baseline to EOS (Week 284)
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).
Baseline to EOS (Week 284)
Proportion of participants with vIGA-AD of 0
Time Frame: Baseline to EOS (Week 284)
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).
Baseline to EOS (Week 284)
Change in percent Body Surface Area (BSA) affected by AD from baseline
Time Frame: Baseline to EOS (Week 284)
BSA affected by AD will measure the extent (area) of the disease.
Baseline to EOS (Week 284)
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants requiring rescue treatment at each visit
Time Frame: Baseline to EOS (Week 284)
Baseline to EOS (Week 284)
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
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants with PP-NRS 0 or 1
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Percent change in weekly average of daily PP-NRS from baseline
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
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
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
Time Frame: Baseline to EOS (Week 284)
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".
Baseline to EOS (Week 284)
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
Time Frame: Baseline to EOS (Week 284)
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".
Baseline to EOS (Week 284)
Change in Patient Oriented Eczema Measure (POEM) from baseline
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants with a reduction in POEM ≥4 from Baseline in participants with POEM baseline ≥4
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of adolescent participants with a reduction in POEM ≥6 from Baseline in adolescents with POEM baseline ≥6
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Change in Atopic Dermatitis Control Test (ADCT) from baseline
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants with a reduction in ADCT ≥5 from baseline in participants with baseline ADCT≥7
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Change in Dermatology Quality of Life Index (DLQI) from baseline in participants with age ≥16 years old
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Change in Children's Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
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
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
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
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants with a reduction in DLQI ≥4 from Baseline in participants with age ≥16 years old and with DLQI at baseline ≥4
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Change in Patient Global Impression of Severity (PGIS) from baseline
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportions of participants who report symptoms to be "No" on the PGIS score
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportions of participants who report symptoms to be "No" or "Mild" on the PGIS score
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants who respond "Much better" on the Patient Global Impression of (PGIC) scale
Time Frame: Week 16 to EOS (Week 284)
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.
Week 16 to EOS (Week 284)
Proportion of participants who respond "Much better" or "A little better" on the PGIC scale
Time Frame: Week 16 to EOS (Week 284)
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.
Week 16 to EOS (Week 284)
Proportion of participants by PGIC responses
Time Frame: Week 16 to EOS (Week 284)
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.
Week 16 to EOS (Week 284)
Change in Hospital Anxiety Depression Scale (HADS) from baseline
Time Frame: Baseline to EOS (Week 284)
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.
Baseline to EOS (Week 284)
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8
Time Frame: Baseline to EOS (Week 284)

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.
Baseline to EOS (Week 284)
Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D Baseline ≥8
Time Frame: Baseline to EOS (Week 284)

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.
Baseline to EOS (Week 284)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Estimated)

June 11, 2031

Study Completion (Estimated)

June 11, 2031

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS17789
  • U1111-1280-6080 (Other Identifier: ICTRP)
  • 2022-502188-39 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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