AzTrials
AzTrials

Dermatitis AtopicPhase 2/3RIVER-ADNCT05492578

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

A Phase 2/3 study testing Amlitelimab, Topical corticosteroids and Topical calcineurin inhibitors in people with Dermatitis Atopic, run by Sanofi at 392 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Dermatitis Atopic
What is being tested?
Amlitelimab, Topical corticosteroids and Topical calcineurin inhibitors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,856 participants
Where
392 sitesin 29 countries
Study dates
22 Aug 2022to 22 Jan 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participant must be at least 12 years of age inclusive at the time of signing the informed consent.
  • Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period.
  • Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600
  • Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:
  • The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2.
  • The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.
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  • The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up.
  • Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
  • Complied with the previous clinical trial protocol to the satisfaction of the investigator
  • Body weight must be ≥25 kg
  • Provided signed informed assent/or consent and able to comply with the requirements of the protocol Exclusion Criteria:
  • Participants are excluded from the study if any of the following criteria apply:
  • Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol
  • Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
  • History of solid organ or stem cell transplant
  • 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)
  • Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test
  • History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  • Participants with active 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
  • Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:
  • Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
  • Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
  • For whom review and approval from Sponsor have been granted are eligible
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
  • Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment
  • Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments
  • In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Who cannot join

None listed.

Trial locations and contacts

392 sites in 29 countries.

392 sites in 29 countries

United States101 sites

  • The University of New Mexico- Site Number : 8401263

    Albuquerque, New Mexico, 87106

  • Orange County Clinical Trials- Site Number : 8401271

    Anaheim, California, 92801

  • Arlington Research Center- Site Number : 8401248

    Arlington, Texas, 76011

  • Care Access Research - Arlington- Site Number : 8401134

    Arlington, Virginia, 22206

  • Velocity Clinical Research at The Dermatology Clinic - Baton Rouge- Site Number : 8401072

    Baton Rouge, Louisiana, 70809

  • Allervie Clinical Research - Birmingham- Site Number : 8401101

    Birmingham, Alabama, 35209

  • Cahaba Dermatology & Skin Health Center- Site Number : 8401066

    Birmingham, Alabama, 35244

  • Equity Medical - Bowling Green- Site Number : 8401296

    Bowling Green, Kentucky, 42104

  • Encore Medical Research of Boynton Beach- Site Number : 8401030

    Boynton Beach, Florida, 33436

  • MetroBoston Clinical Partners - Brighton- Site Number : 8401128

    Brighton, Massachusetts, 02135

  • Best Skin Research - Camp Hill- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011

  • Wyoming Research Foundation- Site Number : 8401234

    Cheyenne, Wyoming, 82001

  • Northwestern University Feinberg School of Medicine- Site Number : 8401285

    Chicago, Illinois, 60611

  • Northwestern University- Site Number : 8401038

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical Center- Site Number : 8401279

    Cincinnati, Ohio, 45229

  • Velocity Clinical Research - Columbia- Site Number : 8401176

    Columbia, South Carolina, 29204

  • Columbia Dermatology & Aesthetics- Site Number : 8401166

    Columbia, South Carolina, 29212

  • Pediatric Skin Research- Site Number : 8401198

    Coral Gables, Florida, 33146

  • MedPharmics - Covington- Site Number : 8401137

    Covington, Louisiana, 70433

  • Dermatology Treatment and Research Center- Site Number : 8401164

    Dallas, Texas, 75230

  • Modern Research Associates- Site Number : 8401093

    Dallas, Texas, 75231

  • Derm Texas- Site Number : 8401217

    Dallas, Texas, 75235

  • Reveal Research Institute - Dallas- Site Number : 8401219

    Dallas, Texas, 75235

  • Cleaver Medical Group- Site Number : 8401138

    Dawsonville, Georgia, 30534

  • Henry Ford Hospital- Site Number : 8401044

    Detroit, Michigan, 48202

  • St. Jude Clinical Research- Site Number : 8401287

    Doral, Florida, 33172

  • Schweiger Dermatology Group - East Windsor- Site Number : 8401338

    East Windsor, New Jersey, 08520

  • Encino Research Center- Site Number : 8401042

    Encino, California, 91436

  • AXIS Clinicals - Fargo- Site Number : 8401196

    Fargo, North Dakota, 58103

  • UConn Health - Farmington- Site Number : 8401115

    Farmington, Connecticut, 06030

  • First Georgia Physician Group- Site Number : 8401190

    Fayetteville, Georgia, 30214

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111

    Fort Myers, Florida, 33912

  • Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286

    Fort Myers, Florida, 33919

  • First OC Dermatology- Site Number : 8401025

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538

  • BRCR Global Gretna- Site Number : 8401243

    Gretna, Louisiana, 70053

  • Pulmonology Group - Henderson- Site Number : 8401169

    Henderson, Nevada, 89052

  • Direct Helpers Research Center- Site Number : 8401056

    Hialeah, Florida, 33012

  • Doral Medical Research - Hialeah- Site Number : 8401094

    Hialeah, Florida, 33016

  • Care Access - Hoboken- Site Number : 8401132

    Hoboken, New Jersey, 07030

  • Prolato Clinical Research Center- Site Number : 8401209

    Houston, Texas, 77054

  • Marvel Clinical Research- Site Number : 8401102

    Huntington Beach, California, 92647

  • Dawes Fretzin Clinical Research- Site Number : 8401015

    Indianapolis, Indiana, 46256

  • Apex Clinical Research - Jacksonville- Site Number : 8401332

    Jacksonville, Florida, 32256

  • Sunwise Clinical Research - Lafayette- Site Number : 8401022

    Lafayette, California, 94549

  • Velocity Clinical Research - Lafayette- Site Number : 8401152

    Lafayette, Louisiana, 70508

  • Antelope Valley Clinical Trials- Site Number : 8401099

    Lancaster, California, 93534

  • Jubilee Clinical Research- Site Number : 8401054

    Las Vegas, Nevada, 89106

  • Tanner Clinic - Layton Antelope A- Site Number : 8401151

    Layton, Utah, 84041

  • Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027

    Lomita, California, 90717

  • Long Beach Clinical Trials- Site Number : 8401188

    Long Beach, California, 90806

  • Dermatology Research Associates- Site Number : 8401092

    Los Angeles, California, 90045

  • LA Universal Research Center- Site Number : 8401064

    Los Angeles, California, 90057

  • Skin Sciences- Site Number : 8401039

    Louisville, Kentucky, 40217

  • Dermatologic Surgery Specialists- Site Number : 8401034

    Macon, Georgia, 31217

  • Apex Clinical Research Center- Site Number : 8401237

    Mayfield Heights, Ohio, 44124

  • SMS Clinical Research- Site Number : 8401182

    Mesquite, Texas, 75149

  • Clever Medical Research- Site Number : 8401160

    Miami, Florida, 33126

  • Miami Dermatology and Laser Research- Site Number : 8401086

    Miami, Florida, 33133

  • Medical Research Center of Miami II- Site Number : 8401019

    Miami, Florida, 33134

  • Acevedo Clinical Research Associates- Site Number : 8401088

    Miami, Florida, 33142

  • Future Care Solution - Miami- Site Number : 8401144

    Miami, Florida, 33142

  • Sanchez Clinical Research- Site Number : 8401095

    Miami, Florida, 33157

  • Florida International Research Center- Site Number : 8401091

    Miami, Florida, 33173

  • Savin Medical Group - Miami Lakes- Site Number : 8401085

    Miami Lakes, Florida, 33014

  • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8401109

    Miami Lakes, Florida, 33016

  • Synapse Clinical Research - Missouri City- Site Number : 8401148

    Missouri City, Texas, 77459

  • Sadick Research Group - New York - Park Avenue- Site Number : 8401050

    New York, New York, 10075

  • OptiSkin- Site Number : 8401163

    New York, New York, 10128

  • University Dermatology Trials- Site Number : 8401339

    Newport Beach, California, 92660

  • Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

    Norfolk, Virginia, 23502

  • Arkansas Research Trials- Site Number : 8401244

    North Little Rock, Arkansas, 72217

  • Skin Specialists- Site Number : 8401068

    Omaha, Nebraska, 68144

  • K2 South Orlando - South Orange Avenue- Site Number : 8401268

    Orlando, Florida, 32806

  • Cura Clinical Research - Oxnard- Site Number : 8401142

    Oxnard, California, 93030

  • Paddington Testing Company- Site Number : 8401041

    Philadelphia, Pennsylvania, 19103

  • Clinical Research of Philadelphia- Site Number : 8401193

    Philadelphia, Pennsylvania, 19114

  • Dermatology Associates of Plymouth Meeting- Site Number : 8401147

    Plymouth Meeting, Pennsylvania, 19462

  • Nuline Clinical Trial Center- Site Number : 8401161

    Pompano Beach, Florida, 33060

  • Oregon Health & Science University (OHSU)- Site Number : 8401247

    Portland, Oregon, 97239

  • Health Concepts- Site Number : 8401059

    Rapid City, South Dakota, 57702

  • SKY Integrative Medical Center/SKYCRNG- Site Number : 8401058

    Ridgeland, Mississippi, 39157

  • Skin Search Rochester- Site Number : 8401216

    Rochester, New York, 14623

  • Southern California Dermatology- Site Number : 8401043

    Santa Ana, California, 92701

  • Clinical Science Institute- Site Number : 8401028

    Santa Monica, California, 90404

  • Aeroallergy Research Laboratory- Site Number : 8401004

    Savannah, Georgia, 31406

  • Center for Dermatology and Plastic Surgery- Site Number : 8401119

    Scottsdale, Arizona, 85260

  • Scottsdale Clinical Trials- Site Number : 8401149

    Scottsdale, Arizona, 85260

  • Stryde Research - Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas, 76092

  • Global Clinical Professionals (GCP)- Site Number : 8401045

    St. Petersburg, Florida, 33714

  • Complete Dermatology - Site Number : 8401061

    Sugar Land, Texas, 77479

  • Clinical Research Trials of Florida- Site Number : 8401023

    Tampa, Florida, 33607

  • Alliance Clinical Research of Tampa- Site Number : 8401013

    Tampa, Florida, 33615

  • Equity Medical (LLC)- Site Number : 8401239

    The Bronx, New York, 10455

  • Javara Research - Thomasville- Site Number : 8401189

    Thomasville, Georgia, 31792

  • Revival Research Institute - Troy- Site Number : 8401012

    Troy, Michigan, 48084

  • Oakland Medical Center- Site Number : 8401116

    Troy, Michigan, 48085

  • Eclipse Clinical Research- Site Number : 8401158

    Tucson, Arizona, 85745

  • Rophe Adult & Pediatric Medicine- Site Number : 8401289

    Union City, Georgia, 30291

  • Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

    Wheat Ridge, Colorado, 80033

  • Allergy Immunology Assoc Ann Arbor- Site Number : 8401078

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada31 sites

  • Investigational Site Number : 1240033

    Ajax, Ontario, L1S 7K8

  • Investigational Site Number : 1240014

    Barrie, Ontario, L4M 7G1

  • Investigational Site Number : 1240039

    Calgary, Alberta, T2J 7E1

  • Investigational Site Number : 1240019

    Calgary, Alberta, T2W 4X9

  • Investigational Site Number : 1240023

    Calgary, Alberta, T3A 2N1

  • Investigational Site Number : 1240016

    Edmonton, Alberta, T5J 3S9

  • Investigational Site Number : 1240031

    Edmonton, Alberta, T5K 2V4

  • Investigational Site Number : 1240020

    Hamilton, Ontario, L8L 3C3

  • Investigational Site Number : 1240029

    London, Ontario, L6A 2C2

  • Investigational Site Number : 1240053

    London, Ontario, N6A 5R9

  • Investigational Site Number : 1240017

    London, Ontario, N6H 5L5

  • Investigational Site Number : 1241106

    Markham, Ontario, L3P 1X2

  • Investigational Site Number : 1240008

    Mississauga, Ontario, L4Y 4C5

  • Investigational Site Number : 1240018

    Newmarket, Ontario, L3Y 9E5

  • Investigational Site Number : 1241108

    Niagara Falls, Ontario, L2H 1H5

  • Investigational Site Number : 1240034

    Ottawa, Ontario, K1K 4L2

  • Investigational Site Number : 1240006

    Québec, Quebec, G1W 4R4

  • Investigational Site Number : 1240045

    Red Deer, Alberta, T4P 1K4

  • Investigational Site Number : 1240028

    Regina, Saskatchewan, S4V 1R9

  • Investigational Site Number : 1240024

    Richmond Hill, Ontario, L4B 1A5

  • Investigational Site Number : 1240038

    Richmond Hill, Ontario, L4E 4L6

  • Investigational Site Number : 1240036

    Saskatoon, Saskatchewan, S7K 0H6

  • Investigational Site Number : 1240040

    Surrey, British Columbia, V3R 6A7

  • Investigational Site Number : 1240030

    Surrey, British Columbia, V3V 0C6

  • Investigational Site Number : 1240021

    Toronto, Ontario, M2N 3A6

  • Investigational Site Number : 1240012

    Toronto, Ontario, M3H 5Y8

  • Investigational Site Number : 1240026

    Toronto, Ontario, M4E 1R7

  • Investigational Site Number : 1240035

    Toronto, Ontario, M5A 3R6

  • Investigational Site Number : 1241107

    Waterloo, Ontario, N2J 1C4

  • Investigational Site Number : 1241101

    Windsor, Ontario, N8W 1E6

  • Investigational Site Number : 1240041

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

China30 sites

  • Investigational Site Number : 1560042

    Beijing, 100034

  • Investigational Site Number : 1560004

    Beijing, 100191

  • Investigational Site Number : 1560030

    Beijing, 100730

  • Investigational Site Number : 1560050

    Changsha, 410011

  • Investigational Site Number : 1560022

    Chengdu, 610041

  • Investigational Site Number : 1560060

    Chengdu, 610072

  • Investigational Site Number : 1560057

    Chongqing, 400016

  • Investigational Site Number : 1560043

    Fuzhou, 350005

  • Investigational Site Number : 1560021

    Guangzhou, 510018

  • Investigational Site Number : 1560025

    Guangzhou, 510080

  • Investigational Site Number : 1560036

    Guangzhou, 510100

  • Investigational Site Number : 1560058

    Guangzhou, 510630

  • Investigational Site Number : 1560044

    Hangzhou, 310003

  • Investigational Site Number : 1560002

    Hangzhou, 310006

  • Investigational Site Number : 1560006

    Hangzhou, 310009

  • Investigational Site Number : 1560029

    Hangzhou, 310014

  • Investigational Site Number : 1560051

    Nanchang, 330001

  • Investigational Site Number : 1560024

    Ningbo, 315010

  • Investigational Site Number : 1560035

    Ningbo, 315010

  • Investigational Site Number : 1560001

    Shanghai, 200040

  • Investigational Site Number : 1560005

    Shanghai, 200443

  • Investigational Site Number : 1560041

    Shenyang, 110001

  • Investigational Site Number : 1560026

    Shenyang, 110179

  • Investigational Site Number : 1560064

    Shenzhen, 518026

  • Investigational Site Number : 1560023

    Wenzhou, 325035

  • Investigational Site Number : 1560049

    Wuhan, 430022

  • Investigational Site Number : 1560038

    Wuhan, 430030

  • Investigational Site Number : 1560003

    Wuxi, 214000

  • Investigational Site Number : 1560032

    Xi'an, 710004

  • Investigational Site Number : 1560028

    Zhenjiang, 212000

Other trials in China

Poland23 sites

  • Investigational Site Number : 6162402

    Gdansk, Pomeranian Voivodeship, 80-382

  • Investigational Site Number : 6160006

    Gdansk, Pomeranian Voivodeship, 80-546

  • Investigational Site Number : 6162403

    Gdansk, Pomeranian Voivodeship, 80-952

  • Investigational Site Number : 6162404

    Gdynia, Pomeranian Voivodeship, 81-537

  • Investigational Site Number : 6162405

    Katowice, Silesian Voivodeship, 40-040

  • Investigational Site Number : 6160003

    Katowice, Silesian Voivodeship, 40-611

  • Investigational Site Number : 6162408

    Krakow, Lesser Poland Voivodeship, 30-033

  • Investigational Site Number : 6162409

    Krakow, Lesser Poland Voivodeship, 31-011

  • Investigational Site Number : 6162406

    Krakow, Lesser Poland Voivodeship, 31-209

  • Investigational Site Number : 6162407

    Krakow, 30-510

  • Investigational Site Number : 6160022

    Lodz, Lódzkie, 90-265

  • Investigational Site Number : 6160004

    Lublin, Lublin Voivodeship, 20-607

  • Investigational Site Number : 6162401

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Investigational Site Number : 6162410

    Szczecin, West Pomeranian Voivodeship, 71-500

  • Investigational Site Number : 6160010

    Tarnów, Lesser Poland Voivodeship, 33-100

  • Investigational Site Number : 6162412

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Investigational Site Number : 6162411

    Warsaw, Masovian Voivodeship, 01-142

  • Investigational Site Number : 6162413

    Warsaw, Masovian Voivodeship, 01-192

  • Investigational Site Number : 6160009

    Warsaw, Masovian Voivodeship, 02-625

  • Investigational Site Number : 6160007

    Warsaw, Masovian Voivodeship, 02-962

  • Investigational Site Number : 6162414

    Wroclaw, Lower Silesian Voivodeship, 50-381

  • Investigational Site Number : 6162418

    Wroclaw, Lower Silesian Voivodeship, 51-318

  • Investigational Site Number : 6162417

    Wroclaw, Lower Silesian Voivodeship, 51-685

Other trials in Poland

Japan22 sites

  • Investigational Site Number : 3920009

    Chitose, Hokkaido, 066-0021

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0031

  • Investigational Site Number : 3923115

    Chūō, 103-0028

  • Investigational Site Number : 3923104

    Edogawa City, Tokyo, 133-0052

  • Investigational Site Number : 3923109

    Habikino, Osaka, 583-8588

  • Investigational Site Number : 3920007

    Hiroshima, 734-8551

  • Investigational Site Number : 3920002

    Iruma, Saitama, 350-0495

  • Investigational Site Number : 3923108

    Kagoshima, 890-0063

  • Investigational Site Number : 3920006

    Kobe, 653-0836

  • Investigational Site Number : 3923102

    Kyoto, 602-8566

  • Investigational Site Number : 3920003

    Kyoto, 606-8507

  • Investigational Site Number : 3923106

    Mibu, Tochigi, 321-0293

  • Investigational Site Number : 3923107

    Minato, Tokyo, 108-0014

  • Investigational Site Number : 3923114

    Obihiro, Hokkaido, 080-0013

  • Investigational Site Number : 3920005

    Sagamihara, Kanagawa, 252-0392

  • Investigational Site Number : 3923110

    Sakai, Osaka, 593-8324

  • Investigational Site Number : 3923101

    Sapporo, Hokkaido, 060-0063

  • Investigational Site Number : 3920008

    Sapporo, 064-0921

  • Investigational Site Number : 3923105

    Setagaya City, Tokyo, 158-0097

  • Investigational Site Number : 3920001

    Tachikawa, Tokyo, 190-0023

  • Investigational Site Number : 3923112

    Tokyo, 120-0034

  • Investigational Site Number : 3923113

    Yokohama, Kanagawa, 221-0825

Other trials in Japan

Argentina20 sites

  • Investigational Site Number : 0320021

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320022

    Buenos Aires, 1012

  • Investigational Site Number : 0320011

    Buenos Aires, 1035

  • Investigational Site Number : 0320016

    Buenos Aires, 1055

  • Investigational Site Number : 0320008

    Buenos Aires, 1061

  • Investigational Site Number : 0320001

    Buenos Aires, 1121

  • Investigational Site Number : 0320018

    Buenos Aires, 1178

  • Investigational Site Number : 0320010

    Buenos Aires, 1414

  • Investigational Site Number : 0320002

    Buenos Aires, 1425

  • Investigational Site Number : 0320004

    Buenos Aires, 1425

  • Investigational Site Number : 0320009

    Buenos Aires, 1425

  • Investigational Site Number : 0320019

    Buenos Aires, 1426

  • Investigational Site Number : 0320005

    Buenos Aires, 1427

  • Investigational Site Number : 0320014

    Córdoba, 5000

  • Investigational Site Number : 0320012

    Corrientes, 3400

  • Investigational Site Number : 0320013

    Mendoza, 5500

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320015

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320020

    San Miguel de Tucumán, Tucumán Province, T4000

Other trials in Argentina

Chile14 sites

  • Investigational Site Number : 1520009

    Osorno, Los Lagos Region, 5311523

  • Investigational Site Number : 1520015

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520013

    Santiago, Reg Metropolitana de Santiago, 7500505

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520014

    Santiago, Reg Metropolitana de Santiago, 7750495

  • Investigational Site Number : 1520010

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520011

    Santiago, Reg Metropolitana de Santiago, 8380456

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8380465

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383

  • Investigational Site Number : 1520012

    Talcahuano, Biobio, 2687000

  • Investigational Site Number : 1520004

    Valdivia, Los Ríos Region, 5110683

  • Investigational Site Number : 1520006

    Viña del Mar, Valparaiso, 2530900

Other trials in Chile

Spain14 sites

  • Investigational Site Number : 7242505

    Alicante, 03010

  • Investigational Site Number : 7240002

    Badalona, Barcelona [Barcelona], 08916

  • Investigational Site Number : 7240008

    Bilbao, Basque Country, 48013

  • Investigational Site Number : 7242501

    Córdoba, 14004

  • Investigational Site Number : 7240010

    Esplugues de Llobregat, Barcelona [Barcelona], 08950

  • Investigational Site Number : 7240018

    Granada, 18014

  • Investigational Site Number : 7240019

    Granada, 18016

  • Investigational Site Number : 7240012

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7242503

    Madrid, Madrid, Comunidad de, 28046

  • Investigational Site Number : 7240015

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7242504

    Pontevedra, Pontevedra [Pontevedra], 36002

  • Investigational Site Number : 7240020

    Seville, Andalusia, 41013

  • Investigational Site Number : 7240023

    Valencia, 46100

  • Investigational Site Number : 7240014

    Vigo, Pontevedra [Pontevedra], 36206

Other trials in Spain

Brazil13 sites

  • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022

    Curitiba, Paraná, 80060-900

  • PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023

    Curitiba, Paraná, 80230-130

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015

    Ribeirão Preto, São Paulo, 14049-900

  • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018

    Rio de Janeiro, 22241-180

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

    Salvador, Estado de Bahia, 41820-020

  • Faculdade de Medicina do ABC- Site Number : 0760001

    Santo André, São Paulo, 09060-650

  • Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010

    São Paulo, 01323-020

  • Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014

    São Paulo, 04020-060

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012

    São Paulo, 05403-000

  • Clinica de Alergia Martti Antila- Site Number : 0760006

    Sorocaba, São Paulo, 18040-425

  • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Germany13 sites

  • Investigational Site Number : 2760020

    Augsburg, 86150

  • Investigational Site Number : 2760009

    Bad Bentheim, 48455

  • Investigational Site Number : 2762203

    Berlin, 10117

  • Investigational Site Number : 2762202

    Blankenfelde-Mahlow, 15831

  • Investigational Site Number : 2761001

    Dresden, 01307

  • Investigational Site Number : 2760022

    Frankfurt, 60590

  • Investigational Site Number : 2762207

    Gera, 07548

  • Investigational Site Number : 2760017

    Hamburg, 20095

  • Investigational Site Number : 2760021

    Hamburg, 20354

  • Investigational Site Number : 2762208

    Kiel, 24105

  • Investigational Site Number : 2761002

    Lübeck, 23562

  • Investigational Site Number : 2760016

    Mainz, 55128

  • Investigational Site Number : 2762201

    Münster, 48149

Other trials in Germany

South Korea13 sites

  • Investigational Site Number : 4100002

    Ansan-si, Gyeonggi-do, 15355

  • Investigational Site Number : 4100015

    Bupyeong-Gu, Incheon-gwangyeoksi, 21431

  • Investigational Site Number : 4100008

    Daegu, Daegu, 41944

  • Investigational Site Number : 4100012

    Gwangju, Gwangju, 61453

  • Investigational Site Number : 4100014

    Seongnam-si, Gyeonggi-do, 13620

  • Investigational Site Number : 4100013

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100010

    Seoul, Seoul-teukbyeolsi, 04654

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100011

    Seoul, Seoul-teukbyeolsi, 06591

  • Investigational Site Number : 4100017

    Seoul, Seoul-teukbyeolsi, 07804

  • Investigational Site Number : 4100009

    Suwon, Gyeonggi-do, 16499

  • Investigational Site Number : 4100003

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Czechia12 sites

  • Investigational Site Number : 2032108

    Brno, 602 00

  • Investigational Site Number : 2032106

    Kutná Hora, 284 01

  • Investigational Site Number : 2032105

    Nový Jičín, 741 01

  • Investigational Site Number : 2030010

    Olomouc, 779 00

  • Investigational Site Number : 2032104

    Ostrava, 702 00

  • Investigational Site Number : 2030009

    Pilsen, 323 00

  • Investigational Site Number : 2032102

    Prague, 100 00

  • Investigational Site Number : 2030008

    Prague, 110 00

  • Investigational Site Number : 2032101

    Prague, 120 00

  • Investigational Site Number : 2032103

    Prague, 130 00

  • Investigational Site Number : 2030011

    Prague, 150 00

  • Investigational Site Number : 2030006

    Prague, 160 00

Other trials in Czechia

Italy12 sites

  • Investigational Site Number : 3800012

    Bologna, 40138

  • Investigational Site Number : 3800009

    Catania, 95123

  • Investigational Site Number : 3800016

    Chieti, 66100

  • Investigational Site Number : 3800011

    L’Aquila, 67100

  • Investigational Site Number : 3800003

    Milan, Milano, 20122

  • Investigational Site Number : 3800021

    Modena, 41125

  • Investigational Site Number : 3800017

    Naples, Napoli, 80131

  • Investigational Site Number : 3800015

    Perugia, 06156

  • Investigational Site Number : 3800008

    Pisa, 56126

  • Investigational Site Number : 3800013

    Rome, Roma, 00133

  • Investigational Site Number : 3800018

    Rozzano, Milano, 20089

  • Investigational Site Number : 3800020

    Turin, Torino, 10126

Other trials in Italy

France9 sites

  • Investigational Site Number : 2500008

    Antony, 92160

  • Investigational Site Number : 2500011

    Bordeaux, 33000

  • Investigational Site Number : 2500014

    Clermont-Ferrand, 63100

  • Investigational Site Number : 2500004

    Créteil, 94010

  • Investigational Site Number : 2500001

    Lille, 59037

  • Investigational Site Number : 2500013

    Nice, 06202

  • Investigational Site Number : 2500007

    Reims, 51100

  • Investigational Site Number : 2500012

    Rouen, 76031

  • Investigational Site Number : 2500002

    Toulouse, 31059

Other trials in France

United Kingdom9 sites

  • Investigational Site Number : 8260013

    Bristol, Bristol, City of, BS2 8HW

  • Investigational Site Number : 8260006

    Glasgow, Glasgow City, G12 0YN

  • Investigational Site Number : 8260004

    Leicester, Leicestershire, LE1 5WW

  • Investigational Site Number : 8260008

    Liverpool, L7 8XP

  • Investigational Site Number : 8262603

    London, England, E11 1NR

  • Investigational Site Number : 8260016

    London, London, City of, Se1 7eh

  • Investigational Site Number : 8262601

    London, London, City of, SE1 9RT

  • Investigational Site Number : 8260010

    Nottingham, Nottinghamshire, NG17 4JL

  • Investigational Site Number : 8260003

    Portsmouth, Hampshire, PO3 6DW

Other trials in United Kingdom

Australia7 sites

  • Investigational Site Number : 0363002

    Carlton, Victoria, 3053

  • Investigational Site Number : 0360007

    Greenslopes, Queensland, 4102

  • Investigational Site Number : 0363003

    Melbourne, Victoria, 3002

  • Investigational Site Number : 0360006

    Melbourne, Victoria, 3004

  • Investigational Site Number : 0363001

    Parkville, Victoria, 3050

  • Investigational Site Number : 0361006

    Traralgon, Victoria, 3844

  • Investigational Site Number : 0360010

    Westmead, New South Wales, 2145

Other trials in Australia

Israel7 sites

  • Investigational Site Number : 3760004

    Afula, 1834111

  • Investigational Site Number : 3760005

    Beersheba, 8457108

  • Investigational Site Number : 3760003

    Jerusalem, 9112001

  • Investigational Site Number : 3760006

    Petah Tikva, 4920235

  • Investigational Site Number : 3760002

    Petah Tikva, 4941492

  • Investigational Site Number : 3760008

    Ramat Gan, 5262100

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906

Other trials in Israel

Bulgaria6 sites

  • Investigational Site Number : 1002007

    Dupnitsa, 2600

  • Investigational Site Number : 1002004

    Pleven, 5800

  • Investigational Site Number : 1002005

    Sofia, 1431

  • Investigational Site Number : 1002003

    Sofia, 1463

  • Investigational Site Number : 1002006

    Sofia, 1592

  • Investigational Site Number : 1002002

    Sofia, 1784

Other trials in Bulgaria

India6 sites

  • Investigational Site Number : 3560001

    Ahmedabad, 380016

  • Investigational Site Number : 3560005

    Belagavi, 590002

  • Investigational Site Number : 3560004

    Chandigarh, 160012

  • Investigational Site Number : 3560007

    Kolkata, 700073

  • Investigational Site Number : 3560002

    Nagpur, 441203

  • Investigational Site Number : 3560003

    Pune, 411057

Other trials in India

South Africa6 sites

  • Investigational Site Number : 7100015

    Benoni, 1500

  • Investigational Site Number : 7100010

    Cape Town, 7533

  • Investigational Site Number : 7100009

    Cape Town, 7708

  • Investigational Site Number : 7100012

    Durban, 3630

  • Investigational Site Number : 7100001

    Durban, 4058

  • Investigational Site Number : 7100007

    Johannesburg, 2196

Other trials in South Africa

Taiwan5 sites

  • Investigational Site Number : 1583201

    Kaohsiung City, 833

  • Investigational Site Number : 1583202

    Taichung, 402

  • Investigational Site Number : 1580001

    Taipei, 100

  • Investigational Site Number : 1580003

    Taipei, 112

  • Investigational Site Number : 1583203

    Taoyuan City, 333

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Investigational Site Number : 7920001

    Antalya, 07070

  • Investigational Site Number : 7920008

    Gaziantep, 27310

  • Investigational Site Number : 7920005

    Istanbul, 34093

  • Investigational Site Number : 7920009

    Istanbul, 34662

  • Investigational Site Number : 7920004

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Mexico3 sites

  • Investigational Site Number : 4840009

    Durango, 34000

  • Investigational Site Number : 4840005

    Monterrey, Nuevo León, 64718

  • Investigational Site Number : 4840003

    Veracruz, 91900

Other trials in Mexico

Portugal3 sites

  • Investigational Site Number : 6200004

    Lisbon, 1649-035

  • Investigational Site Number : 6200001

    Lisbon, 1998-018

  • Investigational Site Number : 6200003

    Porto, 4099-001

Other trials in Portugal

Greece2 sites

  • Investigational Site Number : 3000001

    Athens, 16121

  • Investigational Site Number : 3000002

    Thessaloniki, 54643

Other trials in Greece

Hungary2 sites

  • Investigational Site Number : 3482303

    Debrecen, 4032

  • Investigational Site Number : 3482306

    Szolnok, 5000

Other trials in Hungary

United Arab Emirates2 sites

  • Investigational Site Number : 7841002

    Abu Dhabi, 51900

  • Investigational Site Number : 7840001

    Abu Dhabi

Other trials in United Arab Emirates

Denmark1 site

  • Investigational Site Number : 2080003

    Herlev, 2730

Other trials in Denmark

Saudi Arabia1 site

  • Investigational Site Number : 6820001

    Riyadh, 12713

Other trials in Saudi Arabia

About this study

Official title: A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis.

The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline.

Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.

Being tested
Amlitelimab, Topical corticosteroids, Topical calcineurin inhibitors, Oral corticosteroids
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlitelimabDrug

    Also called SAR445229

    Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

  • Topical corticosteroidsDrug

    Pharmaceutical form: Topical Route of administration: Topical

  • Topical calcineurin inhibitorsDrug

    Pharmaceutical form: Topical Route of administration: Topical

  • Oral corticosteroidsDrug

    Pharmaceutical form: Oral Route of administration: Oral

Study groups in NCT05492578
Study groupRoleWhat they receive
Amlitelimab dose level 1ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors; Drug: Oral corticosteroids
Amlitelimab dose level 2ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors; Drug: Oral corticosteroids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who experienced treatment-emergent adverse event (TEAE)

    Measured: Baseline to Week 332

Secondary outcomes (29)

  1. Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)

    Measured: Baseline to Week 332

  2. Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)

    Measured: Baseline to Week 332

  3. Percentage of participants who experienced TEAE leading to treatment discontinuation

    Measured: Baseline to Week 332

  4. Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: DRI17366 Baseline to Week 332

  5. Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: DRI17366 Baseline to Week 332

  6. Proportion of participants with EASI50/EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.

    Measured: DRI17366 Baseline to Week 332

  7. Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  8. Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit]

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  9. Proportion of participants with vIGA-AD score 0 [each LTS17367 visit]

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  10. Proportion of participants with vIGA-AD score 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  11. Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  12. Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: Baseline to Week 332

  13. Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

    Measured: Baseline to Week 332

  14. Proportion of participants with EASI50/EASI75/EASI90 in all participants entering the study [each LTS17367 visit]

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline.

    Measured: Baseline to Week 332

  15. Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline.

    Measured: Baseline to Week 332

  16. Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit]

    Measured: Baseline to Week 332

  17. Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study

    Measured: Baseline to Week 332

  18. Number of days on topical medication (per patient-year) in all participants entering the study

    Measured: Baseline to Week 332

  19. Change from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit]

    ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicate worsening disease control.

    Measured: Baseline to Week 332

  20. Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit]

    The DLQI is a validated 10-item questionnaire to measure dermatology specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    The children's DLQI (cDLQI) measures dermatology specific quality of life (QoL) in children patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Measured: Baseline to Week 332

  21. Change from feeder study baseline in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit]

    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.

    Measured: Baseline to Week 332

  22. Change from feeder study baseline in body surface area affected by AD (BSA-AD) [each LTS17367 visit]

    BSA-AD measured as percentage of body affected by AD.

    Measured: Baseline to Week 332

  23. Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  24. Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA)

    EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline.

    Measured: Baseline to Week 332

  25. Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  26. Time from LTS17367 baseline to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2

    = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  27. Time from last amlitelimab dose in feeder study to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)

    The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2

    = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 332

  28. Serum amlitelimab concentration assessed at prespecified time points through the end of the study

    Serum amlitelimab concentration assessed at prespecified time points through the end of the study.

    Measured: Baseline to Week 332

  29. Number of participants with anti-drug antibodies (ADAs) of amlitelimab at specified timepoints

    Measured: Baseline to Week 332

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start22 Aug 2022
  3. Primary completion22 Jan 2029 (estimated)
  4. Study completion22 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,856 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05492578
Sponsor's protocol ID
LTS17367
Other IDs
U1111-1269-6490, 2023-506548-18, KY1005-CT06, 2021-002344-73, 2023
Acronym
RIVER-AD
Status last verified
Oct 2026
First submitted
5 Aug 2022
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Amlitelimab, Topical corticosteroids and Topical calcineurin inhibitors in people with Dermatitis Atopic, run by Sanofi at 392 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 392 sites in United States, Canada, China, Poland, Japan and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who experienced treatment-emergent adverse event (TEAE) (time frame: Baseline to Week 332). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05492578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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