Actively Recruiting
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
Led by Sanofi · Updated on 2026-05-08
636
Participants Needed
147
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 12 years of age or older when signing the informed consent form
- Diagnosis of atopic dermatitis for at least 1 year according to American Academy of Dermatology criteria
- Documented history of inadequate response to biologic AD medication or oral JAK inhibitor therapy before screening
- Validated Investigator Global Assessment for AD score of 3 or 4 at baseline
- Eczema Area and Severity Index score of 16 or higher at baseline
- Atopic dermatitis affecting 10% or more of body surface area at baseline
- Weekly average of daily peak pruritus numerical rating scale of 4 or higher at baseline
- Ability and willingness to comply with study visits and procedures
- Body weight of 25 kilograms or more
You will not qualify if you...
- Skin conditions that interfere with atopic dermatitis assessments
- Known or suspected significant current immunosuppression
- Any current or past malignancies except non-melanoma skin cancer excised and cured more than 5 years before baseline
- History of solid organ or stem cell transplant
- Active or chronic infections requiring systemic treatment within 4 weeks before baseline
- Positive for HIV, Hepatitis B, or Hepatitis C at screening
- Active tuberculosis, latent tuberculosis, incomplete or suspected extrapulmonary tuberculosis, or high risk of tuberculosis
- Receipt of specified therapies within defined timeframes before baseline
- Clinically significant laboratory abnormalities or results at screening
- History of allergy or hypersensitivity to study drug or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 147 locations
1
University of Alabama at Birmingham- Site Number : 8401267
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona, United States, 85260
Actively Recruiting
3
Arkansas Dermatology - North Little Rock- Site Number : 8401244
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
4
Encino Research Center- Site Number : 8401042
Encino, California, United States, 91436
Actively Recruiting
5
Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, California, United States, 94538
Actively Recruiting
6
Long Beach Clinical Trials- Site Number : 8401188
Long Beach, California, United States, 90806
Actively Recruiting
7
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California, United States, 90045
Actively Recruiting
8
LA Universal Research Center- Site Number : 8401064
Los Angeles, California, United States, 90057
Actively Recruiting
9
University Dermatology Trials- Site Number : 8401339
Newport Beach, California, United States, 92660
Actively Recruiting
10
Rady Children's Hospital- Site Number : 8401291
San Diego, California, United States, 92123
Actively Recruiting
11
Therapeutics Clinical Research- Site Number : 8401283
San Diego, California, United States, 92123
Actively Recruiting
12
Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
Wheat Ridge, Colorado, United States, 80033
Actively Recruiting
13
Encore Medical Research of Boynton Beach- Site Number : 8401030
Boynton Beach, Florida, United States, 33436
Actively Recruiting
14
St. Jude Clinical Research- Site Number : 8401287
Doral, Florida, United States, 33172
Actively Recruiting
15
Apex Clinical Research - Jacksonville- Site Number : 8401332
Jacksonville, Florida, United States, 32256
Actively Recruiting
16
Global Clinical Professionals (GCP)- Site Number : 8401045
St. Petersburg, Florida, United States, 33705
Actively Recruiting
17
Avita Clinical Research- Site Number : 8401073
Tampa, Florida, United States, 33613
Actively Recruiting
18
Northwestern University- Site Number : 8401285
Chicago, Illinois, United States, 60611
Actively Recruiting
19
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
Skokie, Illinois, United States, 60077
Actively Recruiting
20
Dawes Fretzin Clinical Research- Site Number : 8401015
Indianapolis, Indiana, United States, 46256
Actively Recruiting
21
Equity Medical - Bowling Green- Site Number : 8401296
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
22
Tandem Clinical Research - Metairie- Site Number : 8401187
Metairie, Louisiana, United States, 70006
Actively Recruiting
23
University of Michigan Health System - Ann Arbor- Site Number : 8401290
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
24
MI Skin Center- Site Number : 8401307
Northville, Michigan, United States, 48167
Actively Recruiting
25
Skin Specialists- Site Number : 8401068
Omaha, Nebraska, United States, 68144
Actively Recruiting
26
Schweiger Dermatology Group - East Windsor- Site Number : 8401338
East Windsor, New Jersey, United States, 08520
Actively Recruiting
27
The University of New Mexico- Site Number : 8401263
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
28
Equity Medical- Site Number : 8401239
New York, New York, United States, 10023
Actively Recruiting
29
Sadick Research Group - New York - Park Avenue- Site Number : 8401050
New York, New York, United States, 10075
Actively Recruiting
30
Cincinnati Children's Hospital Medical Center- Site Number : 8401279
Cincinnati, Ohio, United States, 45229
Actively Recruiting
31
Oregon Health & Science University (OHSU)- Site Number : 8401247
Portland, Oregon, United States, 97239
Actively Recruiting
32
Paddington Testing Company- Site Number : 8401041
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
33
Clinical Research of Philadelphia- Site Number : 8401193
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
34
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282
Charleston, South Carolina, United States, 29425
Actively Recruiting
35
Arlington Research Center- Site Number : 8401248
Arlington, Texas, United States, 76011
Actively Recruiting
36
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288
Bellaire, Texas, United States, 77401
Actively Recruiting
37
Reveal Research Institute - Dallas- Site Number : 8401219
Dallas, Texas, United States, 75235
Actively Recruiting
38
Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057
Ogden, Utah, United States, 84405
Actively Recruiting
39
Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
Norfolk, Virginia, United States, 23502
Actively Recruiting
40
North Sound Dermatology- Site Number : 8401280
Mill Creek, Washington, United States, 98012
Actively Recruiting
41
Children's Wisconsin- Site Number : 8401246
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
42
Cheyenne Skin Clinic- Site Number : 8401234
Cheyenne, Wyoming, United States, 82009
Actively Recruiting
43
Investigational Site Number : 0320007
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
44
Investigational Site Number : 0320011
Buenos Aires, Argentina, 1035
Actively Recruiting
45
Investigational Site Number : 0320019
Buenos Aires, Argentina, 1426
Actively Recruiting
46
Investigational Site Number : 0320014
Córdoba, Argentina, 5000
Actively Recruiting
47
Investigational Site Number : 0360008
Melbourne, Victoria, Australia, 3002
Actively Recruiting
48
Investigational Site Number : 0360006
Melbourne, Victoria, Australia, 3004
Actively Recruiting
49
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
Salvador, Estado de Bahia, Brazil, 41820-020
Actively Recruiting
50
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
51
Faculdade de Medicina do ABC- Site Number : 0760001
Santo André, São Paulo, Brazil, 09060-650
Actively Recruiting
52
Clinica de Alergia Martti Antila- Site Number : 0760006
Sorocaba, São Paulo, Brazil, 18040-425
Completed
53
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
São Paulo, Brazil, 01323-020
Actively Recruiting
54
Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
São Paulo, Brazil, 04020-060
Actively Recruiting
55
Investigational Site Number : 1240019
Calgary, Alberta, Canada, T2W 4X9
Actively Recruiting
56
Investigational Site Number : 1240016
Edmonton, Alberta, Canada, T5J 3S9
Actively Recruiting
57
Investigational Site Number : 1240058
Burlington, Ontario, Canada, L7L 6W6
Actively Recruiting
58
Investigational Site Number : 1240020
Hamilton, Ontario, Canada, L8L 3C3
Actively Recruiting
59
Investigational Site Number : 1240053
London, Ontario, Canada, N6A 5R9
Actively Recruiting
60
Investigational Site Number : 1240054
Toronto, Ontario, Canada, M5m 3z8
Actively Recruiting
61
Investigational Site Number : 1240028
Regina, Saskatchewan, Canada, S4V 1R9
Actively Recruiting
62
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 7580206
Actively Recruiting
63
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile, 7640881
Actively Recruiting
64
Investigational Site Number : 1520010
Santiago, Reg Metropolitana de Santiago, Chile, 8330034
Actively Recruiting
65
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile, 8380465
Actively Recruiting
66
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 8420383
Actively Recruiting
67
Investigational Site Number : 1560031
Changchun, China, 130021
Actively Recruiting
68
Investigational Site Number : 1560021
Guangzhou, China, 510018
Actively Recruiting
69
Investigational Site Number : 1560036
Guangzhou, China, 510100
Actively Recruiting
70
Investigational Site Number : 1560044
Hangzhou, China, 310003
Actively Recruiting
71
Investigational Site Number : 1560002
Hangzhou, China, 310006
Actively Recruiting
72
Investigational Site Number : 1560009
Hangzhou, China, 310009
Actively Recruiting
73
Investigational Site Number : 1560034
Nanyang, China, 473014
Actively Recruiting
74
Investigational Site Number : 1560024
Ningbo, China, 315010
Actively Recruiting
75
Investigational Site Number : 1560035
Ningbo, China, 315010
Actively Recruiting
76
Investigational Site Number : 1560001
Shanghai, China, 200040
Actively Recruiting
77
Investigational Site Number : 1560005
Shanghai, China, 200443
Actively Recruiting
78
Investigational Site Number : 1560041
Shenyang, China, 110001
Actively Recruiting
79
Investigational Site Number : 1560038
Wuhan, China, 430030
Actively Recruiting
80
Investigational Site Number : 1560032
Xi'an, China, 710004
Actively Recruiting
81
Investigational Site Number : 2500011
Bordeaux, France, 33000
Actively Recruiting
82
Investigational Site Number : 2500014
Clermont-Ferrand, France, 63100
Active, Not Recruiting
83
Investigational Site Number : 2500004
Créteil, France, 94010
Actively Recruiting
84
Investigational Site Number : 2500001
Lille, France, 59037
Actively Recruiting
85
Investigational Site Number : 2500017
Paris, France, 75010
Actively Recruiting
86
Investigational Site Number : 2500012
Rouen, France, 76031
Actively Recruiting
87
Investigational Site Number : 2762203
Berlin, Germany, 10117
Actively Recruiting
88
Investigational Site Number : 2762202
Blankenfelde-Mahlow, Germany, 15831
Actively Recruiting
89
Investigational Site Number : 2761001
Dresden, Germany, 01307
Actively Recruiting
90
Investigational Site Number : 2760022
Frankfurt, Germany, 60590
Actively Recruiting
91
Investigational Site Number : 2761002
Lübeck, Germany, 23562
Actively Recruiting
92
Investigational Site Number : 2760019
Witten, Germany, 58453
Actively Recruiting
93
Investigational Site Number : 3000004
Athens, Greece, 124 62
Actively Recruiting
94
Investigational Site Number : 3000001
Athens, Greece, 16121
Actively Recruiting
95
Investigational Site Number : 3000005
Athens, Greece, 16121
Actively Recruiting
96
Investigational Site Number : 3000002
Thessaloniki, Greece, 54643
Actively Recruiting
97
Investigational Site Number : 3760005
Beersheba, Israel, 8457108
Actively Recruiting
98
Investigational Site Number : 3760008
Ramat Gan, Israel, 5262100
Actively Recruiting
99
Investigational Site Number : 3760007
Tel Aviv, Israel, 6423906
Actively Recruiting
100
Investigational Site Number : 3800020
Turin, Torino, Italy, 10126
Actively Recruiting
101
Center for Advanced Studies and Technology-Site Number: 3800016
Chieti, Italy, 66100
Actively Recruiting
102
A.O.U. di Modena -Site Number: 3800021
Modena, Italy, 41125
Actively Recruiting
103
UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"-Site Number : 3800017
Naples, Italy, 80131
Actively Recruiting
104
Azienda ospedaliera di Perugia - Ospedale "Santa Maria della Misericordia"-Site Number: 3800015
Perugia, Italy, 06129
Actively Recruiting
105
Investigational Site Number : 3923113
Yokohama, Kanagawa, Japan, 221-0825
Actively Recruiting
106
Investigational Site Number : 3923109
Habikino, Osaka, Japan, 583-8588
Actively Recruiting
107
Investigational Site Number : 3923110
Sakai, Osaka, Japan, 593-8324
Actively Recruiting
108
Investigational Site Number : 3923106
Mibu, Tochigi, Japan, 321-0293
Actively Recruiting
109
Investigational Site Number : 3920001
Tachikawa, Tokyo, Japan, 190-0023
Actively Recruiting
110
Investigational Site Number : 3920007
Hiroshima, Japan, 734-8551
Actively Recruiting
111
Investigational Site Number : 4840011
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
112
Investigational Site Number : 4840003
Veracruz, Mexico, 91900
Actively Recruiting
113
Investigational Site Number : 6162417
Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
Actively Recruiting
114
Investigational Site Number : 6160002
Lublin, Lublin Voivodeship, Poland, 20-363
Actively Recruiting
115
Investigational Site Number : 6162411
Warsaw, Masovian Voivodeship, Poland, 01-142
Actively Recruiting
116
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland, 02-507
Actively Recruiting
117
Investigational Site Number : 6160006
Gdansk, Pomeranian Voivodeship, Poland, 80-546
Actively Recruiting
118
Investigational Site Number : 2500016
Saint-Pierre, Reunion, 97448
Actively Recruiting
119
Investigational Site Number : 6820001
Riyadh, Saudi Arabia, 12713
Actively Recruiting
120
Investigational Site Number : 4100002
Ansan-si, Gyeonggi-do, South Korea, 15355
Actively Recruiting
121
Investigational Site Number : 4100014
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
122
Investigational Site Number : 4100015
Bupyeong-Gu, Incheon-gwangyeoksi, South Korea, 21431
Actively Recruiting
123
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Actively Recruiting
124
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 07441
Actively Recruiting
125
Investigational Site Number : 7240002
Badalona, Barcelona [Barcelona], Spain, 08916
Actively Recruiting
126
Investigational Site Number : 7240017
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
127
Investigational Site Number : 7240020
Seville, Sevilla, Spain, 41013
Actively Recruiting
128
Investigational Site Number : 7242505
Alicante, Spain, 03010
Actively Recruiting
129
Investigational Site Number : 7242503
Madrid, Spain, 28046
Actively Recruiting
130
Investigational Site Number : 1583201
Kaohsiung City, Taiwan, 833
Active, Not Recruiting
131
Investigational Site Number : 1580001
Taipei, Taiwan, 100
Actively Recruiting
132
Investigational Site Number : 1580003
Taipei, Taiwan
Actively Recruiting
133
Investigational Site Number : 1583203
Taoyuan City, Taiwan, 333
Actively Recruiting
134
Investigational Site Number : 7920008
Gaziantep, Turkey (Türkiye), 27310
Actively Recruiting
135
Investigational Site Number : 7920005
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
136
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
137
Investigational Site Number : 7841002
Abu Dhabi, United Arab Emirates, 51900
Actively Recruiting
138
Investigational Site Number : 7840001
Abu Dhabi, United Arab Emirates, 6222
Actively Recruiting
139
Investigational Site Number : 7840002
Abu Dhabi, United Arab Emirates
Actively Recruiting
140
Investigational Site Number : 8260013
Bristol, Bristol, City of, United Kingdom, BS2 8HW
Actively Recruiting
141
Investigational Site Number : 8260012
Plymouth, Devon, United Kingdom, PL6 8DH
Actively Recruiting
142
Investigational Site Number : 8262603
London, England, United Kingdom, E11 1NR
Actively Recruiting
143
Investigational Site Number : 8260015
London, England, United Kingdom, SW10 9NH
Actively Recruiting
144
Investigational Site Number : 8260003
Portsmouth, Hampshire, United Kingdom, PO3 6DW
Actively Recruiting
145
Investigational Site Number : 8260009
Leeds, North Yorkshire, United Kingdom, Ls7 4sa
Actively Recruiting
146
Investigational Site Number : 8260010
Nottingham, Nottinghamshire, United Kingdom, NG17 4JL
Actively Recruiting
147
Investigational Site Number : 8260008
Liverpool, United Kingdom, L7 8XP
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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