A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Start Date
2/29/2024
Completion Date
9/29/2028
Summary
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
Amlitelimab
Placebo
Topical corticosteroids
Topical tacrolimus or pimecrolimus
Conditions
Locations
University of Alabama at Birmingham- Site Number : 8401267
Birmingham, Alabama 35233
United States
Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona 85260
United States
Arkansas Dermatology - North Little Rock- Site Number : 8401244
North Little Rock, Arkansas 72117
United States
Encino Research Center- Site Number : 8401042
Encino, California 91436
United States
Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, California 94538
United States
Long Beach Clinical Trials- Site Number : 8401188
Long Beach, California 90806
United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California 90045
United States
LA Universal Research Center- Site Number : 8401064
Los Angeles, California 90057
United States
University Dermatology Trials- Site Number : 8401339
Newport Beach, California 92660
United States
Rady Children's Hospital- Site Number : 8401291
San Diego, California 92123
United States
Therapeutics Clinical Research- Site Number : 8401283
San Diego, California 92123
United States
Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
Wheat Ridge, Colorado 80033
United States
Encore Medical Research of Boynton Beach- Site Number : 8401030
Boynton Beach, Florida 33436
United States
St. Jude Clinical Research- Site Number : 8401287
Doral, Florida 33172
United States
Apex Clinical Research - Jacksonville- Site Number : 8401332
Jacksonville, Florida 32256
United States
Clever Medical Research- Site Number : 8401160
Miami, Florida 33126
United States
Global Clinical Professionals (GCP)- Site Number : 8401045
St. Petersburg, Florida 33714
United States
Avita Clinical Research- Site Number : 8401073
Tampa, Florida 33613
United States
Northwestern University- Site Number : 8401285
Chicago, Illinois 60611
United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
Skokie, Illinois 60077
United States
Dawes Fretzin Clinical Research- Site Number : 8401015
Indianapolis, Indiana 46256
United States
Equity Medical - Bowling Green- Site Number : 8401296
Bowling Green, Kentucky 42104
United States
Tandem Clinical Research - Metairie- Site Number : 8401187
Metairie, Louisiana 70006
United States
University of Michigan Health System - Ann Arbor- Site Number : 8401290
Ann Arbor, Michigan 48109
United States
MI Skin Center- Site Number : 8401307
Northville, Michigan 48167
United States
Skin Specialists- Site Number : 8401068
Omaha, Nebraska 68144
United States
Schweiger Dermatology Group - East Windsor- Site Number : 8401338
East Windsor, New Jersey 08520
United States
The University of New Mexico- Site Number : 8401263
Albuquerque, New Mexico 87106
United States
Equity Medical- Site Number : 8401239
New York, New York 10023
United States
Sadick Research Group - New York - Park Avenue- Site Number : 8401050
New York, New York 10075
United States
Cincinnati Children's Hospital Medical Center- Site Number : 8401279
Cincinnati, Ohio 45229
United States
Oregon Health & Science University (OHSU)- Site Number : 8401247
Portland, Oregon 97239
United States
Paddington Testing Company- Site Number : 8401041
Philadelphia, Pennsylvania 19103
United States
Clinical Research of Philadelphia- Site Number : 8401193
Philadelphia, Pennsylvania 19114
United States
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282
Charleston, South Carolina 29425
United States
Arlington Research Center- Site Number : 8401248
Arlington, Texas 76011
United States
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288
Bellaire, Texas 77401
United States
Reveal Research Institute - Dallas- Site Number : 8401219
Dallas, Texas 75235
United States
Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057
Ogden, Utah 84405
United States
Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
Norfolk, Virginia 23502
United States
North Sound Dermatology- Site Number : 8401280
Mill Creek, Washington 98012
United States
Children's Wisconsin- Site Number : 8401246
Milwaukee, Wisconsin 53226
United States
Cheyenne Skin Clinic- Site Number : 8401234
Cheyenne, Wyoming 82009
United States
Investigational Site Number : 0320007
Rosario, Santa Fe Province 2000
Argentina
Investigational Site Number : 0320011
Buenos Aires, 1035
Argentina
Investigational Site Number : 0320019
Buenos Aires, 1426
Argentina
Investigational Site Number : 0320014
Córdoba, 5000
Argentina
Investigational Site Number : 0360008
Melbourne, Victoria 3002
Australia
Investigational Site Number : 0360006
Melbourne, Victoria 3004
Australia
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
Salvador, Estado de Bahia 41820-020
Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
Santo André, São Paulo 09060-650
Brazil
Clinica de Alergia Martti Antila- Site Number : 0760006
Sorocaba, São Paulo 18040-425
Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
São Paulo, 01323-020
Brazil
Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
São Paulo, 04020-060
Brazil
Investigational Site Number : 1240019
Calgary, Alberta T2W 4X9
Canada
Investigational Site Number : 1240016
Edmonton, Alberta T5J 3S9
Canada
Investigational Site Number : 1240058
Burlington, Ontario L7L 6W6
Canada
Investigational Site Number : 1240020
Hamilton, Ontario L8L 3C3
Canada
Investigational Site Number : 1240053
London, Ontario N6A 5R9
Canada
Investigational Site Number : 1240035
Toronto, Ontario M5A 3R6
Canada
Investigational Site Number : 1240054
Toronto, Ontario M5m 3z8
Canada
Investigational Site Number : 1240028
Regina, Saskatchewan S4V 1R9
Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago 7580206
Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago 7640881
Chile
Investigational Site Number : 1520010
Santiago, Reg Metropolitana de Santiago 8330034
Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago 8380465
Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago 8420383
Chile
Investigational Site Number : 1560031
Changchun, 130021
China
Investigational Site Number : 1560057
Chongqing, 400016
China
Investigational Site Number : 1560021
Guangzhou, 510018
China
Investigational Site Number : 1560036
Guangzhou, 510100
China
Investigational Site Number : 1560044
Hangzhou, 310003
China
Investigational Site Number : 1560002
Hangzhou, 310006
China
Investigational Site Number : 1560009
Hangzhou, 310009
China
Investigational Site Number : 1560034
Nanyang, 473014
China
Investigational Site Number : 1560024
Ningbo, 315010
China
Investigational Site Number : 1560035
Ningbo, 315010
China
Investigational Site Number : 1560001
Shanghai, 200040
China
Investigational Site Number : 1560005
Shanghai, 200443
China
Investigational Site Number : 1560041
Shenyang, 110001
China
Investigational Site Number : 1560038
Wuhan, 430030
China
Investigational Site Number : 1560032
Xi'an, 710004
China
Investigational Site Number : 2500011
Bordeaux, 33000
France
Investigational Site Number : 2500014
Clermont-Ferrand, 63100
France
Investigational Site Number : 2500004
Créteil, 94010
France
Investigational Site Number : 2500001
Lille, 59037
France
Investigational Site Number : 2500017
Paris, 75010
France
Investigational Site Number : 2500012
Rouen, 76031
France
Investigational Site Number : 2762203
Berlin, 10117
Germany
Investigational Site Number : 2762202
Blankenfelde-Mahlow, 15831
Germany
Investigational Site Number : 2761001
Dresden, 01307
Germany
Investigational Site Number : 2760022
Frankfurt, 60590
Germany
Investigational Site Number : 2761002
Lübeck, 23562
Germany
Investigational Site Number : 2760019
Witten, 58453
Germany
Investigational Site Number : 3000004
Athens, 124 62
Greece
Investigational Site Number : 3000001
Athens, 16121
Greece
Investigational Site Number : 3000005
Athens, 16121
Greece
Investigational Site Number : 3000002
Thessaloniki, 54643
Greece
Investigational Site Number : 3760005
Beersheba, 8457108
Israel
Investigational Site Number : 3760008
Ramat Gan, 5262100
Israel
Investigational Site Number : 3760007
Tel Aviv, 6423906
Israel
Investigational Site Number : 3800020
Turin, Torino 10126
Italy
Center for Advanced Studies and Technology-Site Number: 3800016
Chieti, 66100
Italy
A.O.U. di Modena -Site Number: 3800021
Modena, 41125
Italy
UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"-Site Number : 3800017
Naples, 80131
Italy
Azienda ospedaliera di Perugia - Ospedale "Santa Maria della Misericordia"-Site Number: 3800015
Perugia, 06129
Italy
Investigational Site Number : 3923113
Yokohama, Kanagawa 221-0825
Japan
Investigational Site Number : 3923109
Habikino, Osaka 583-8588
Japan
Investigational Site Number : 3923110
Sakai, Osaka 593-8324
Japan
Investigational Site Number : 3923106
Mibu, Tochigi 321-0293
Japan
Investigational Site Number : 3920001
Tachikawa, Tokyo 190-0023
Japan
Investigational Site Number : 3920007
Hiroshima, 734-8551
Japan
Investigational Site Number : 4840011
Monterrey, Nuevo León 64460
Mexico
Investigational Site Number : 4840003
Veracruz, 91900
Mexico
Investigational Site Number : 6162417
Wroclaw, Lower Silesian Voivodeship 51-685
Poland
Investigational Site Number : 6160002
Lublin, Lublin Voivodeship 20-363
Poland
Investigational Site Number : 6162411
Warsaw, Masovian Voivodeship 01-142
Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship 02-507
Poland
Investigational Site Number : 6160006
Gdansk, Pomeranian Voivodeship 80-546
Poland
Investigational Site Number : 2500016
Saint-Pierre, 97448
Reunion
Investigational Site Number : 6820001
Riyadh, 12713
Saudi Arabia
Investigational Site Number : 4100002
Ansan-si, Gyeonggi-do 15355
South Korea
Investigational Site Number : 4100014
Seongnam-si, Gyeonggi-do 13620
South Korea
Investigational Site Number : 4100015
Bupyeong-Gu, Incheon-gwangyeoksi 21431
South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi 03722
South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi 07441
South Korea
Investigational Site Number : 7240002
Badalona, Barcelona [Barcelona] 08916
Spain
Investigational Site Number : 7240017
Majadahonda, Madrid 28222
Spain
Investigational Site Number : 7240020
Seville, Sevilla 41013
Spain
Investigational Site Number : 7242505
Alicante, 03010
Spain
Investigational Site Number : 7242503
Madrid, 28046
Spain
Investigational Site Number : 1583201
Kaohsiung City, 833
Taiwan
Investigational Site Number : 1580001
Taipei, 100
Taiwan
Investigational Site Number : 1580003
Taipei,
Taiwan
Investigational Site Number : 1583203
Taoyuan City, 333
Taiwan
Investigational Site Number : 7920008
Gaziantep, 27310
Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, 34093
Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, 34098
Turkey (Türkiye)
Investigational Site Number : 7841002
Abu Dhabi, 51900
United Arab Emirates
Investigational Site Number : 7840001
Abu Dhabi, 6222
United Arab Emirates
Investigational Site Number : 7840002
Abu Dhabi,
United Arab Emirates
Investigational Site Number : 8260013
Bristol, Bristol, City of BS2 8HW
United Kingdom
Investigational Site Number : 8260012
Plymouth, Devon PL6 8DH
United Kingdom
Investigational Site Number : 8262603
London, England E11 1NR
United Kingdom
Investigational Site Number : 8260015
London, England SW10 9NH
United Kingdom
Investigational Site Number : 8260003
Portsmouth, Hampshire PO3 6DW
United Kingdom
Investigational Site Number : 8260009
Leeds, North Yorkshire Ls7 4sa
United Kingdom
Investigational Site Number : 8260010
Nottingham, Nottinghamshire NG17 4JL
United Kingdom
Investigational Site Number : 8260008
Liverpool, L7 8XP
United Kingdom