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

Status: Recruiting
Location: See all (179) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Allervie Clinical Research- Site Number : 8400050
RECRUITING
Birmingham
Arkansas
Dermatology Trial Associates- Site Number : 8400027
RECRUITING
Bryant
Arizona
Research Solutions of Arizona- Site Number : 8400020
RECRUITING
Litchfield Park
Medical Dermatology Specialists- Site Number : 8400016
RECRUITING
Phoenix
California
University Dermatology Trials, INC.- Site Number : 8400052
RECRUITING
Newport Beach
Colorado
Childrens Hospital Colorado- Site Number : 8400041
RECRUITING
Aurora
IMMUNOe International Research Centers - Centennial- Site Number : 8400024
RECRUITING
Centennial
Florida
Renaissance Research and Medical Group- Site Number : 8400006
RECRUITING
Cape Coral
Life Clinical Trials - Coral Springs- Site Number : 8400040
RECRUITING
Coral Springs
Bio-Medical Research- Site Number : 8400037
RECRUITING
Miami
Florida Pharmaceutical Research and Associates, Inc.- Site Number : 8400018
RECRUITING
Miami
Florida Research Center, Inc.- Site Number : 8400011
RECRUITING
Miami
Miami Clinical Research- Site Number : 8400036
RECRUITING
Miami
Clinical Research Trials of Florida- Site Number : 8400054
RECRUITING
Tampa
Georgia
Advanced Medical Research PC- Site Number : 8400044
RECRUITING
Sandy Springs
Georgia Skin and Cancer Clinic- Site Number : 8400048
RECRUITING
Savannah
Iowa
Velocity Clinical Research, Sioux City- Site Number : 8400046
RECRUITING
Sioux City
Illinois
Sneeze Wheeze And Itch Assoc- Site Number : 8400002
RECRUITING
Normal
Kentucky
Kentucky Advanced Medical Research- Site Number : 8400014
RECRUITING
Murray
Michigan
Oakland Hills Dermatology- Site Number : 8400021
RECRUITING
Auburn Hills
The Derm Institute of West Michigan- Site Number : 8400043
RECRUITING
Caledonia
Michigan Dermatology Institute- Site Number : 8401010
RECRUITING
Livonia
Michigan Dermatology Institute - Waterford- Site Number : 8400010
RECRUITING
Waterford
New York
Forest Hills Dermatology Group- Site Number : 8400007
RECRUITING
Kew Gardens
Oklahoma
Unity Clinical Research- Site Number : 8400001
RECRUITING
Oklahoma City
Dermatology Research Center of Oklahoma, PLLC - Site Number : 8400035
RECRUITING
Tulsa
Pennsylvania
The Children's Hospital of Philadelphia- Site Number : 8400009
RECRUITING
Philadelphia
Texas
Texas Dermatology and Laser Specialists- Site Number : 8400053
RECRUITING
San Antonio
Pioneer Research Solutions- Site Number : 8400026
RECRUITING
Sugar Land
Wisconsin
Private Practice - Dr. Marthe N. Dika- Site Number : 8400022
RECRUITING
Burlington
Other Locations
Argentina
Investigational Site Number : 0320001
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320009
RECRUITING
Buenos Aires
Investigational Site Number : 0320004
RECRUITING
Caba
Investigational Site Number : 0320005
RECRUITING
Caba
Investigational Site Number : 0320008
ACTIVE_NOT_RECRUITING
Caba
Investigational Site Number : 0320002
RECRUITING
Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320003
RECRUITING
Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320022
RECRUITING
Gral. Pico
Investigational Site Number : 0320006
ACTIVE_NOT_RECRUITING
Rosario
Investigational Site Number : 0320007
ACTIVE_NOT_RECRUITING
Rosario
Australia
Investigational Site Number : 0360002
RECRUITING
Kogarah
Investigational Site Number : 0360001
RECRUITING
Sydney
Brazil
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná- Site Number : 0760022
RECRUITING
Curitiba
PUCPR - Pontificia Universidade Catolica do Parana- Site Number : 0760023
ACTIVE_NOT_RECRUITING
Curitiba
Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760005
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo (HCFMRP-USP)- Site Number : 0760008
RECRUITING
Ribeirão Preto
IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004
RECRUITING
Rio De Janeiro
Instituto Bahiano de Imunoterapia - IBIS- Site Number : 0760002
RECRUITING
Salvador
FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC)- Site Number : 0760001
ACTIVE_NOT_RECRUITING
Santo André
Hospital de Base Sao Jose do Rio Preto- Site Number : 0760003
ACTIVE_NOT_RECRUITING
São José Do Rio Preto
Clinica de Alergia Martti Antila- Site Number : 0760006
RECRUITING
Sorocaba
Canada
Investigational Site Number : 1240001
RECRUITING
Calgary
Investigational Site Number : 1240052
RECRUITING
Edmonton
Investigational Site Number : 1240009
RECRUITING
Etobicoke
Investigational Site Number : 1240008
RECRUITING
Mississauga
Investigational Site Number : 1240002
RECRUITING
Montreal
Investigational Site Number : 1240011
RECRUITING
Oakville
Investigational Site Number : 1240004
RECRUITING
Peterborough
Investigational Site Number : 1240006
RECRUITING
Québec
Investigational Site Number : 1240010
RECRUITING
Québec
Investigational Site Number : 1240003
RECRUITING
Richmond Hill
Investigational Site Number : 1240044
RECRUITING
Saskatoon
Investigational Site Number : 1240012
RECRUITING
Toronto
Investigational Site Number : 1240051
RECRUITING
Vancouver
Chile
Investigational Site Number : 1520014
RECRUITING
Chillán
Investigational Site Number : 1520009
RECRUITING
Osorno
Investigational Site Number : 1520001
RECRUITING
Santiago
Investigational Site Number : 1520002
RECRUITING
Santiago
Investigational Site Number : 1520003
ACTIVE_NOT_RECRUITING
Santiago
Investigational Site Number : 1520005
RECRUITING
Santiago
Investigational Site Number : 1520008
RECRUITING
Santiago
Investigational Site Number : 1520010
RECRUITING
Santiago
Investigational Site Number : 1520011
RECRUITING
Santiago
Investigational Site Number : 1520013
RECRUITING
Santiago
Investigational Site Number : 1520004
RECRUITING
Valdivia
China
Investigational Site Number : 1560015
RECRUITING
Beijing
Investigational Site Number : 1560008
RECRUITING
Changchun
Investigational Site Number : 1560016
RECRUITING
Changsha
Investigational Site Number : 1560014
RECRUITING
Chengdu
Investigational Site Number : 1560072
RECRUITING
Fuzhou
Investigational Site Number : 1560074
RECRUITING
Guangzhou
Investigational Site Number : 1560044
RECRUITING
Hangzhou
Investigational Site Number : 1560013
RECRUITING
Jingzhou
Investigational Site Number : 1560001
RECRUITING
Shanghai
Investigational Site Number : 1560018
RECRUITING
Suzhou
Investigational Site Number : 1560010
RECRUITING
Taiyuan
Investigational Site Number : 1560073
RECRUITING
Taizhou
Investigational Site Number : 1560019
RECRUITING
Xinxiang
Investigational Site Number : 1560012
RECRUITING
Yinchuan
Investigational Site Number : 1560011
RECRUITING
Yiwu
Investigational Site Number : 1560028
RECRUITING
Zhenjiang
Denmark
Investigational Site Number : 2080001
RECRUITING
Aarhus
France
Investigational Site Number : 2500004
ACTIVE_NOT_RECRUITING
Créteil
Investigational Site Number : 2500001
RECRUITING
Lille
Investigational Site Number : 2500005
ACTIVE_NOT_RECRUITING
Marseille
Investigational Site Number : 2500009
RECRUITING
Nantes
Investigational Site Number : 2500003
ACTIVE_NOT_RECRUITING
Paris
Investigational Site Number : 2500006
ACTIVE_NOT_RECRUITING
Pierre-bénite
Investigational Site Number : 2500002
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Investigational Site Number : 2760009
RECRUITING
Bad Bentheim
Investigational Site Number : 2762203
RECRUITING
Berlin
Investigational Site Number : 2762201
RECRUITING
Münster
Investigational Site Number : 2760010
RECRUITING
Osnabrück
India
Investigational Site Number : 3560006
RECRUITING
Bangalore
Investigational Site Number : 3560007
RECRUITING
Bikaner
Investigational Site Number : 3560003
RECRUITING
Gurugram
Investigational Site Number : 3560011
RECRUITING
Kochi
Investigational Site Number : 3560005
RECRUITING
Kolkata
Investigational Site Number : 3560004
RECRUITING
Mangaluru
Investigational Site Number : 3560002
RECRUITING
Nashik
Investigational Site Number : 3560008
RECRUITING
Surat
Italy
Investigational Site Number : 3800005
RECRUITING
Brescia
Investigational Site Number : 3800003
RECRUITING
Milan
Investigational Site Number : 3800002
RECRUITING
Naples
Investigational Site Number : 3800004
RECRUITING
Napoli
Investigational Site Number : 3800007
RECRUITING
Roma
Investigational Site Number : 3800006
RECRUITING
Rome
Investigational Site Number : 3800008
RECRUITING
Vicenza
Japan
Investigational Site Number : 3923106
RECRUITING
Mibu
Investigational Site Number : 3923114
RECRUITING
Obihiro-shi
Investigational Site Number : 3923110
RECRUITING
Sakai-shi
Investigational Site Number : 3920001
RECRUITING
Tachikawa-shi
Investigational Site Number : 3923113
RECRUITING
Yokohama
Mexico
Investigational Site Number : 4840001
RECRUITING
Chihuahua City
Investigational Site Number : 4840008
RECRUITING
Durango
Netherlands
Investigational Site Number : 5280002
RECRUITING
Breda
Investigational Site Number : 5280004
RECRUITING
Rotterdam
Investigational Site Number : 5280001
RECRUITING
Utrecht
Poland
Investigational Site Number : 6160001
RECRUITING
Chorzów
Investigational Site Number : 6160006
RECRUITING
Gdansk
Investigational Site Number : 6160003
RECRUITING
Katowice
Investigational Site Number : 6160014
RECRUITING
Lodz
Investigational Site Number : 6160012
RECRUITING
Lublin
Investigational Site Number : 6160007
RECRUITING
Warsaw
Investigational Site Number : 6160009
RECRUITING
Warsaw
Investigational Site Number : 6162411
RECRUITING
Warsaw
Puerto Rico
Caribbean Medical Research Center- Site Number : 8400028
RECRUITING
San Juan
GCM Medical Group- Site Number : 8400049
RECRUITING
San Juan
Republic of Korea
Investigational Site Number : 4100002
RECRUITING
Ansan-si
Investigational Site Number : 4100016
ACTIVE_NOT_RECRUITING
Bucheon-si
Investigational Site Number : 4100018
ACTIVE_NOT_RECRUITING
Incheon
Investigational Site Number : 4100001
ACTIVE_NOT_RECRUITING
Seoul
Investigational Site Number : 4100006
ACTIVE_NOT_RECRUITING
Seoul
Investigational Site Number : 4100003
ACTIVE_NOT_RECRUITING
Yangsan
South Africa
Investigational Site Number : 7100002
RECRUITING
Cape Town
Investigational Site Number : 7100009
RECRUITING
Cape Town
Investigational Site Number : 7100010
RECRUITING
Cape Town
Investigational Site Number : 7100011
RECRUITING
Cape Town
Investigational Site Number : 7100012
RECRUITING
Durban
Investigational Site Number : 7100015
RECRUITING
Durban
Investigational Site Number : 7100007
RECRUITING
Johannesburg
Investigational Site Number : 7100006
RECRUITING
Kempton Park
Investigational Site Number : 7100005
RECRUITING
Middelburg
Investigational Site Number : 7100003
RECRUITING
Pretoria
Investigational Site Number : 7100014
RECRUITING
Pretoria
Investigational Site Number : 7100004
RECRUITING
Reiger Park
Spain
Investigational Site Number : 7242505
RECRUITING
Alicante
Investigational Site Number : 7240002
RECRUITING
Badalona
Investigational Site Number : 7242501
RECRUITING
Córdoba
Investigational Site Number : 7240021
RECRUITING
Madrid
Investigational Site Number : 7242503
RECRUITING
Madrid
Investigational Site Number : 7240022
RECRUITING
Sabadell
Investigational Site Number : 7240006
ACTIVE_NOT_RECRUITING
Valencia
Switzerland
Investigational Site Number : 7560002
RECRUITING
Buochs
Taiwan
Investigational Site Number : 1580006
ACTIVE_NOT_RECRUITING
Hsinchu
Investigational Site Number : 1583201
ACTIVE_NOT_RECRUITING
Kaohsiung City
Investigational Site Number : 1580002
ACTIVE_NOT_RECRUITING
New Taipei City
Investigational Site Number : 1580007
ACTIVE_NOT_RECRUITING
Taichung
Investigational Site Number : 1583202
ACTIVE_NOT_RECRUITING
Taichung
Investigational Site Number : 1580001
ACTIVE_NOT_RECRUITING
Taipei
Investigational Site Number : 1583203
ACTIVE_NOT_RECRUITING
Taoyuan
Turkey
Investigational Site Number : 7920002
RECRUITING
Aydin
Investigational Site Number : 7920003
RECRUITING
Kocaeli
Investigational Site Number : 7920005
RECRUITING
Manisa
Investigational Site Number : 7920004
RECRUITING
Trabzon
United Kingdom
Investigational Site Number : 8260002
ACTIVE_NOT_RECRUITING
Edinburgh
Investigational Site Number : 8260001
ACTIVE_NOT_RECRUITING
London
Investigational Site Number : 8262601
ACTIVE_NOT_RECRUITING
London
Investigational Site Number : 8260004
RECRUITING
Sheffield
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2023-04-03
Estimated Completion Date: 2031-06-11
Participants
Target number of participants: 901
Treatments
Experimental: Amlitelimab
Subcutaneous injection as per protocol
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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