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
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Dermatitis Atopic
Спонсор: Sanofi
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
Amlitelimab
DRUG
Места на провеждане
174
Argentina (10)
Investigational Site Number : 0320008
Buenos Aires
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320003
Buenos Aires
Investigational Site Number : 0320002
Buenos Aires
Investigational Site Number : 0320004
Buenos Aires
Investigational Site Number : 0320009
Buenos Aires
Investigational Site Number : 0320005
Buenos Aires
Investigational Site Number : 0320022
General Pico , La Pampa Province
Investigational Site Number : 0320006
Rosario , Santa Fe Province
Investigational Site Number : 0320007
Rosario , Santa Fe Province
Австралия (2)
Investigational Site Number : 0360002
Kogarah , New South Wales
Investigational Site Number : 0360001
Sydney , New South Wales
Бразилия (9)
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022
Curitiba , Paraná
Pontifica Universidade Catolica do Parana- Site Number : 0760023
Curitiba , Paraná
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
Porto Alegre , Rio Grande do Sul
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008
Ribeirão Preto , São Paulo
IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004
Rio de Janeiro
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
Salvador , Estado de Bahia
Faculdade de Medicina do ABC- Site Number : 0760001
Santo André , São Paulo
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003
São José do Rio Preto , São Paulo
Clinica de Alergia Martti Antila- Site Number : 0760006
Sorocaba , São Paulo
Канада (12)
Investigational Site Number : 1240001
Calgary , Alberta
Investigational Site Number : 1240009
Etobicoke , Ontario
Investigational Site Number : 1240008
Mississauga , Ontario
Investigational Site Number : 1240002
Montreal , Quebec
Investigational Site Number : 1240011
Oakville , Ontario
Investigational Site Number : 1240004
Peterborough , Ontario
Investigational Site Number : 1240010
Québec , Quebec
Investigational Site Number : 1240006
Québec , Quebec
Investigational Site Number : 1240003
Richmond Hill , Ontario
Investigational Site Number : 1240044
Saskatoon , Saskatchewan
Investigational Site Number : 1240012
Toronto , Ontario
Investigational Site Number : 1240051
Vancouver , British Columbia
Chile (11)
Investigational Site Number : 1520014
Chillan
Investigational Site Number : 1520013
Lo Barnechea , Reg Metropolitana de Santiago
Investigational Site Number : 1520009
Osorno , Los Lagos Region
Investigational Site Number : 1520011
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520008
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520002
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520003
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520010
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520005
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520001
Santiago , Reg Metropolitana de Santiago
Investigational Site Number : 1520004
Valdivia , Los Ríos Region
Китай (16)
Investigational Site Number : 1560015
Beijing
Investigational Site Number : 1560008
Changchun
Investigational Site Number : 1560016
Changsha
Investigational Site Number : 1560014
Chengdu
Investigational Site Number : 1560072
Fuzhou
Investigational Site Number : 1560074
Guangzhou
Investigational Site Number : 1560044
Hangzhou
Investigational Site Number : 1560013
Jingzhou
Investigational Site Number : 1560001
Shanghai
Investigational Site Number : 1560018
Suzhou
Investigational Site Number : 1560010
Taiyuan
Investigational Site Number : 1560073
Taizhou
Investigational Site Number : 1560019
Xinxiang
Investigational Site Number : 1560012
Yinchuan
Investigational Site Number : 1560011
Yiwu
Investigational Site Number : 1560028
Zhenjiang
Чехия (6)
Investigational Site Number : 2032105
Nový Jičín
Investigational Site Number : 2032104
Ostrava
Investigational Site Number : 2032102
Prague
Investigational Site Number : 2030003
Prague
Investigational Site Number : 2030006
Prague
Investigational Site Number : 2030007
Prague
Дания (1)
Investigational Site Number : 2080001
Aarhus
Франция (7)
Investigational Site Number : 2500004
Créteil
Investigational Site Number : 2500001
Lille
Investigational Site Number : 2500005
Marseille
Investigational Site Number : 2500009
Nantes
Investigational Site Number : 2500003
Paris
Investigational Site Number : 2500006
Pierre-Bénite
Investigational Site Number : 2500002
Toulouse
Германия (8)
Investigational Site Number : 2760020
Augsburg
Investigational Site Number : 2760009
Bad Bentheim
Investigational Site Number : 2762203
Berlin
Investigational Site Number : 2762205
Dresden
Investigational Site Number : 2762201
Münster
Investigational Site Number : 2760010
Osnabrück
Investigational Site Number : 2760021
Rostock
Investigational Site Number : 2760019
Witten
Индия (7)
Investigational Site Number : 3560006
Bengaluru
Investigational Site Number : 3560007
Bikaner
Investigational Site Number : 3560011
Kochi
Investigational Site Number : 3560005
Kolkata
Investigational Site Number : 3560004
Mangaluru
Investigational Site Number : 3560002
Nashik
Investigational Site Number : 3560008
Surat
Италия (7)
Investigational Site Number : 3800005
Brescia
Investigational Site Number : 3800003
Milan , Milano
Investigational Site Number : 3800002
Naples , Napoli
Investigational Site Number : 3800004
Naples , Napoli
Investigational Site Number : 3800007
Rome , Roma
Investigational Site Number : 3800006
Rome , Roma
Investigational Site Number : 3800008
Vicenza
Япония (5)
Investigational Site Number : 3923106
Mibu , Tochigi
Investigational Site Number : 3923114
Obihiro , Hokkaido
Investigational Site Number : 3923110
Sakai , Osaka
Investigational Site Number : 3920001
Tachikawa , Tokyo
Investigational Site Number : 3923113
Yokohama , Kanagawa
Mexico (2)
Investigational Site Number : 4840001
Chihuahua City
Investigational Site Number : 4840008
Durango
Нидерландия (3)
Investigational Site Number : 5280002
Breda
Investigational Site Number : 5280004
Rotterdam
Investigational Site Number : 5280001
Utrecht
Полша (8)
Investigational Site Number : 6160001
Chorzów , Silesian Voivodeship
Investigational Site Number : 6160006
Gdansk , Pomeranian Voivodeship
Investigational Site Number : 6160003
Katowice , Silesian Voivodeship
Investigational Site Number : 6160014
Lodz , Lódzkie
Investigational Site Number : 6160012
Lublin , Lublin Voivodeship
Investigational Site Number : 6162411
Warsaw , Masovian Voivodeship
Investigational Site Number : 6160009
Warsaw , Masovian Voivodeship
Investigational Site Number : 6160007
Warsaw , Masovian Voivodeship
Puerto Rico (1)
Caribbean Medical Research Center- Site Number : 8400028
San Juan
South Africa (12)
Investigational Site Number : 7100004
Boksburg
Investigational Site Number : 7100011
Cape Town
Investigational Site Number : 7100010
Cape Town
Investigational Site Number : 7100002
Cape Town
Investigational Site Number : 7100009
Cape Town
Investigational Site Number : 7100012
Durban
Investigational Site Number : 7100015
Durban
Investigational Site Number : 7100007
Johannesburg
Investigational Site Number : 7100006
Kempton Park
Investigational Site Number : 7100005
Middelburg
Investigational Site Number : 7100003
Pretoria
Investigational Site Number : 7100014
Pretoria
Южна Корея (6)
Investigational Site Number : 4100002
Ansan-si , Gyeonggi-do
Investigational Site Number : 4100016
Bucheon-si , Gyeonggi-do
Investigational Site Number : 4100018
Incheon , Incheon-gwangyeoksi
Investigational Site Number : 4100006
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100001
Seoul , Seoul-teukbyeolsi
Investigational Site Number : 4100003
Yangsan , Gyeongsangnam-do
Испания (6)
Investigational Site Number : 7242505
Alicante
Investigational Site Number : 7240002
Badalona , Barcelona [Barcelona]
Investigational Site Number : 7242501
Córdoba
Investigational Site Number : 7242503
Madrid
Investigational Site Number : 7240022
Sabadell , Barcelona [Barcelona]
Investigational Site Number : 7240006
Valencia
Швейцария (1)
Investigational Site Number : 7560002
Buochs
Taiwan (7)
Investigational Site Number : 1580006
Hsinchu
Investigational Site Number : 1583201
Kaohsiung City
Investigational Site Number : 1580002
New Taipei City
Investigational Site Number : 1583202
Taichung
Investigational Site Number : 1580007
Taichung
Investigational Site Number : 1580001
Taipei
Investigational Site Number : 1583203
Taoyuan
Турция (1)
Investigational Site Number : 7920005
Manisa
Великобритания (4)
Investigational Site Number : 8260002
Edinburgh
Investigational Site Number : 8260001
London , England
Investigational Site Number : 8262601
London , London, City of
Investigational Site Number : 8260004
Sheffield
САЩ (22)
Advanced Medical Research - Atlanta- Site Number : 8400044
Atlanta , Georgia
Children's Hospital Colorado - Aurora- Site Number : 8400041
Aurora , Colorado
Allervie Clinical Research - Birmingham- Site Number : 8400050
Birmingham , Alabama
Dermatology Trial Associates- Site Number : 8400027
Bryant , Arkansas
Private Practice - Dr. Marthe N. Dika- Site Number : 8400022
Burlington , Wisconsin
The Derm Institute of West Michigan- Site Number : 8400043
Caledonia , Michigan
Renaissance Research and Medical Group- Site Number : 8400006
Cape Coral , Florida
IMMUNOe International Research Centers - Centennial- Site Number : 8400024
Centennial , Colorado
Research Solutions of Arizona- Site Number : 8400020
Litchfield Park , Arizona
Michigan Dermatology Institute - Livonia- Site Number : 8401010
Livonia , Michigan
Miami Clinical Research Tower- Site Number : 8400036
Miami , Florida
Florida Research Center- Site Number : 8400011
Miami , Florida
Florida Pharmaceutical Research and Associates- Site Number : 8400018
Miami , Florida
Kentucky Advanced Medical Research- Site Number : 8400014
Murray , Kentucky
University Dermatology Trials- Site Number : 8400052
Newport Beach , California
Sneeze Wheeze & Itch Associates- Site Number : 8400002
Normal , Illinois
The Children's Hospital of Philadelphia- Site Number : 8400009
Philadelphia , Pennsylvania
Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053
San Antonio , Texas
Georgia Skin & Cancer Clinic- Site Number : 8400048
Savannah , Georgia
Clinical Research Trials of Florida- Site Number : 8400054
Tampa , Florida
Dermatology Research Center of Oklahoma- Site Number : 8400035
Tulsa , Oklahoma
Michigan Dermatology Institute - Waterford- Site Number : 8400010