Atopic Dermatitis Clinical Trials

Find Atopic Dermatitis Clinical Trials Near You

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 (169) 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 - Birmingham- Site Number : 8400050
ACTIVE_NOT_RECRUITING
Birmingham
Arkansas
Dermatology Trial Associates- Site Number : 8400027
ACTIVE_NOT_RECRUITING
Bryant
Arizona
Research Solutions of Arizona- Site Number : 8400020
ACTIVE_NOT_RECRUITING
Litchfield Park
California
University Dermatology Trials- Site Number : 8400052
ACTIVE_NOT_RECRUITING
Newport Beach
Colorado
Children's Hospital Colorado - Aurora- Site Number : 8400041
ACTIVE_NOT_RECRUITING
Aurora
IMMUNOe International Research Centers - Centennial- Site Number : 8400024
COMPLETED
Centennial
Florida
Renaissance Research and Medical Group- Site Number : 8400006
ACTIVE_NOT_RECRUITING
Cape Coral
Florida Pharmaceutical Research and Associates- Site Number : 8400018
ACTIVE_NOT_RECRUITING
Miami
Florida Research Center- Site Number : 8400011
ACTIVE_NOT_RECRUITING
Miami
Miami Clinical Research Tower- Site Number : 8400036
ACTIVE_NOT_RECRUITING
Miami
Clinical Research Trials of Florida- Site Number : 8400054
ACTIVE_NOT_RECRUITING
Tampa
Georgia
Advanced Medical Research - Atlanta- Site Number : 8400044
ACTIVE_NOT_RECRUITING
Atlanta
Georgia Skin & Cancer Clinic- Site Number : 8400048
ACTIVE_NOT_RECRUITING
Savannah
Illinois
Sneeze Wheeze & Itch Associates- Site Number : 8400002
COMPLETED
Normal
Kentucky
Kentucky Advanced Medical Research- Site Number : 8400014
ACTIVE_NOT_RECRUITING
Murray
Michigan
The Derm Institute of West Michigan- Site Number : 8400043
ACTIVE_NOT_RECRUITING
Caledonia
Michigan Dermatology Institute - Livonia- Site Number : 8401010
ACTIVE_NOT_RECRUITING
Livonia
Michigan Dermatology Institute - Waterford- Site Number : 8400010
COMPLETED
Waterford
Oklahoma
Dermatology Research Center of Oklahoma- Site Number : 8400035
COMPLETED
Tulsa
Pennsylvania
The Children's Hospital of Philadelphia- Site Number : 8400009
ACTIVE_NOT_RECRUITING
Philadelphia
Texas
Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053
ACTIVE_NOT_RECRUITING
San Antonio
Wisconsin
Private Practice - Dr. Marthe N. Dika- Site Number : 8400022
COMPLETED
Burlington
Other Locations
Argentina
Investigational Site Number : 0320001
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320002
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320003
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320004
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320005
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320008
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320009
ACTIVE_NOT_RECRUITING
Buenos Aires
Investigational Site Number : 0320022
ACTIVE_NOT_RECRUITING
General Pico
Investigational Site Number : 0320006
ACTIVE_NOT_RECRUITING
Rosario
Investigational Site Number : 0320007
ACTIVE_NOT_RECRUITING
Rosario
Australia
Investigational Site Number : 0360002
ACTIVE_NOT_RECRUITING
Kogarah
Investigational Site Number : 0360001
ACTIVE_NOT_RECRUITING
Sydney
Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022
ACTIVE_NOT_RECRUITING
Curitiba
Pontifica Universidade Catolica do Parana- Site Number : 0760023
ACTIVE_NOT_RECRUITING
Curitiba
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008
ACTIVE_NOT_RECRUITING
Ribeirão Preto
IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004
ACTIVE_NOT_RECRUITING
Rio De Janeiro
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
ACTIVE_NOT_RECRUITING
Salvador
Faculdade de Medicina do ABC- Site Number : 0760001
ACTIVE_NOT_RECRUITING
Santo André
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003
COMPLETED
São José Do Rio Preto
Clinica de Alergia Martti Antila- Site Number : 0760006
ACTIVE_NOT_RECRUITING
Sorocaba
Canada
Investigational Site Number : 1240001
COMPLETED
Calgary
Investigational Site Number : 1240052
ACTIVE_NOT_RECRUITING
Edmonton
Investigational Site Number : 1240009
COMPLETED
Etobicoke
Investigational Site Number : 1240008
ACTIVE_NOT_RECRUITING
Mississauga
Investigational Site Number : 1240002
ACTIVE_NOT_RECRUITING
Montreal
Investigational Site Number : 1240011
ACTIVE_NOT_RECRUITING
Oakville
Investigational Site Number : 1240004
ACTIVE_NOT_RECRUITING
Peterborough
Investigational Site Number : 1240006
ACTIVE_NOT_RECRUITING
Québec
Investigational Site Number : 1240010
ACTIVE_NOT_RECRUITING
Québec
Investigational Site Number : 1240003
ACTIVE_NOT_RECRUITING
Richmond Hill
Investigational Site Number : 1240044
ACTIVE_NOT_RECRUITING
Saskatoon
Investigational Site Number : 1240012
ACTIVE_NOT_RECRUITING
Toronto
Investigational Site Number : 1240051
ACTIVE_NOT_RECRUITING
Vancouver
Chile
Investigational Site Number : 1520014
RECRUITING
Chillán
Investigational Site Number : 1520013
ACTIVE_NOT_RECRUITING
Lo Barnechea
Investigational Site Number : 1520009
ACTIVE_NOT_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
ACTIVE_NOT_RECRUITING
Santiago
Investigational Site Number : 1520011
ACTIVE_NOT_RECRUITING
Santiago
Investigational Site Number : 1520004
RECRUITING
Valdivia
China
Investigational Site Number : 1560015
ACTIVE_NOT_RECRUITING
Beijing
Investigational Site Number : 1560008
ACTIVE_NOT_RECRUITING
Changchun
Investigational Site Number : 1560016
ACTIVE_NOT_RECRUITING
Changsha
Investigational Site Number : 1560014
ACTIVE_NOT_RECRUITING
Chengdu
Investigational Site Number : 1560072
ACTIVE_NOT_RECRUITING
Fuzhou
Investigational Site Number : 1560074
ACTIVE_NOT_RECRUITING
Guangzhou
Investigational Site Number : 1560044
ACTIVE_NOT_RECRUITING
Hangzhou
Investigational Site Number : 1560013
ACTIVE_NOT_RECRUITING
Jingzhou
Investigational Site Number : 1560001
ACTIVE_NOT_RECRUITING
Shanghai
Investigational Site Number : 1560018
ACTIVE_NOT_RECRUITING
Suzhou
Investigational Site Number : 1560010
ACTIVE_NOT_RECRUITING
Taiyuan
Investigational Site Number : 1560073
ACTIVE_NOT_RECRUITING
Taizhou
Investigational Site Number : 1560019
RECRUITING
Xinxiang
Investigational Site Number : 1560012
COMPLETED
Yinchuan
Investigational Site Number : 1560011
ACTIVE_NOT_RECRUITING
Yiwu
Investigational Site Number : 1560028
ACTIVE_NOT_RECRUITING
Zhenjiang
Denmark
Investigational Site Number : 2080001
ACTIVE_NOT_RECRUITING
Aarhus
France
Investigational Site Number : 2500004
ACTIVE_NOT_RECRUITING
Créteil
Investigational Site Number : 2500001
ACTIVE_NOT_RECRUITING
Lille
Investigational Site Number : 2500005
ACTIVE_NOT_RECRUITING
Marseille
Investigational Site Number : 2500009
ACTIVE_NOT_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 : 2760020
RECRUITING
Augsburg
Investigational Site Number : 2760009
RECRUITING
Bad Bentheim
Investigational Site Number : 2762203
RECRUITING
Berlin
Investigational Site Number : 2762205
RECRUITING
Dresden
Investigational Site Number : 2762201
RECRUITING
Münster
Investigational Site Number : 2760010
RECRUITING
Osnabrück
Investigational Site Number : 2760021
RECRUITING
Rostock
Investigational Site Number : 2760019
RECRUITING
Witten
India
Investigational Site Number : 3560006
COMPLETED
Bengaluru
Investigational Site Number : 3560007
ACTIVE_NOT_RECRUITING
Bikaner
Investigational Site Number : 3560011
RECRUITING
Kochi
Investigational Site Number : 3560005
ACTIVE_NOT_RECRUITING
Kolkata
Investigational Site Number : 3560004
ACTIVE_NOT_RECRUITING
Mangaluru
Investigational Site Number : 3560002
ACTIVE_NOT_RECRUITING
Nashik
Investigational Site Number : 3560008
ACTIVE_NOT_RECRUITING
Surat
Italy
Investigational Site Number : 3800005
ACTIVE_NOT_RECRUITING
Brescia
Investigational Site Number : 3800003
ACTIVE_NOT_RECRUITING
Milan
Investigational Site Number : 3800002
ACTIVE_NOT_RECRUITING
Naples
Investigational Site Number : 3800004
ACTIVE_NOT_RECRUITING
Naples
Investigational Site Number : 3800006
ACTIVE_NOT_RECRUITING
Rome
Investigational Site Number : 3800007
ACTIVE_NOT_RECRUITING
Rome
Investigational Site Number : 3800008
ACTIVE_NOT_RECRUITING
Vicenza
Japan
Investigational Site Number : 3923106
ACTIVE_NOT_RECRUITING
Mibu
Investigational Site Number : 3923114
ACTIVE_NOT_RECRUITING
Obihiro
Investigational Site Number : 3923110
ACTIVE_NOT_RECRUITING
Sakai
Investigational Site Number : 3920001
ACTIVE_NOT_RECRUITING
Tachikawa
Investigational Site Number : 3923113
ACTIVE_NOT_RECRUITING
Yokohama
Mexico
Investigational Site Number : 4840001
ACTIVE_NOT_RECRUITING
Chihuahua City
Investigational Site Number : 4840008
ACTIVE_NOT_RECRUITING
Durango
Netherlands
Investigational Site Number : 5280002
ACTIVE_NOT_RECRUITING
Breda
Investigational Site Number : 5280004
ACTIVE_NOT_RECRUITING
Rotterdam
Investigational Site Number : 5280001
ACTIVE_NOT_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
COMPLETED
San Juan
Republic of Korea
Investigational Site Number : 4100002
ACTIVE_NOT_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 : 7100004
RECRUITING
Boksburg
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
Spain
Investigational Site Number : 7242505
ACTIVE_NOT_RECRUITING
Alicante
Investigational Site Number : 7240002
ACTIVE_NOT_RECRUITING
Badalona
Investigational Site Number : 7242501
COMPLETED
Córdoba
Investigational Site Number : 7242503
ACTIVE_NOT_RECRUITING
Madrid
Investigational Site Number : 7240022
ACTIVE_NOT_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 : 7920005
RECRUITING
Manisa
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
ACTIVE_NOT_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

Similar Clinical Trials