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

NCT ID: NCT05492578

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1663 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2029-01-22

Brief Summary

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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.

Detailed Description

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Conditions

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Dermatitis Atopic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amlitelimab dose level 1

Subcutaneous injection as per protocol

Group Type EXPERIMENTAL

Amlitelimab

Intervention Type DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Topical corticosteroids

Intervention Type DRUG

Pharmaceutical form: Topical Route of administration: Topical

Topical calcineurin inhibitors

Intervention Type DRUG

Pharmaceutical form: Topical Route of administration: Topical

Oral corticosteroids

Intervention Type DRUG

Pharmaceutical form: Oral Route of administration: Oral

Amlitelimab dose level 2

Subcutaneous injection as per protocol

Group Type EXPERIMENTAL

Amlitelimab

Intervention Type DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Topical corticosteroids

Intervention Type DRUG

Pharmaceutical form: Topical Route of administration: Topical

Topical calcineurin inhibitors

Intervention Type DRUG

Pharmaceutical form: Topical Route of administration: Topical

Oral corticosteroids

Intervention Type DRUG

Pharmaceutical form: Oral Route of administration: Oral

Interventions

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Amlitelimab

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Intervention Type DRUG

Topical corticosteroids

Pharmaceutical form: Topical Route of administration: Topical

Intervention Type DRUG

Topical calcineurin inhibitors

Pharmaceutical form: Topical Route of administration: Topical

Intervention Type DRUG

Oral corticosteroids

Pharmaceutical form: Oral Route of administration: Oral

Intervention Type DRUG

Other Intervention Names

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SAR445229

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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

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:

1. 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
2. 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
3. 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Allervie Clinical Research - Birmingham- Site Number : 8401101

Birmingham, Alabama, United States

Site Status

Cahaba Dermatology & Skin Health Center- Site Number : 8401066

Birmingham, Alabama, United States

Site Status

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, United States

Site Status

Scottsdale Clinical Trials- Site Number : 8401149

Scottsdale, Arizona, United States

Site Status

Arkansas Research Trials- Site Number : 8401244

North Little Rock, Arkansas, United States

Site Status

Orange County Clinical Trials- Site Number : 8401271

Anaheim, California, United States

Site Status

Encino Research Center- Site Number : 8401042

Encino, California, United States

Site Status

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, United States

Site Status

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, United States

Site Status

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, United States

Site Status

Antelope Valley Clinical Trials- Site Number : 8401099

Lancaster, California, United States

Site Status

Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027

Lomita, California, United States

Site Status

Long Beach Clinical Trials- Site Number : 8401188

Long Beach, California, United States

Site Status

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California, United States

Site Status

LA Universal Research Center- Site Number : 8401064

Los Angeles, California, United States

Site Status

Cura Clinical Research - Oxnard- Site Number : 8401142

Oxnard, California, United States

Site Status

Southern California Dermatology- Site Number : 8401043

Santa Ana, California, United States

Site Status

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, United States

Site Status

Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

Wheat Ridge, Colorado, United States

Site Status

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida, United States

Site Status

St. Jude Clinical Research- Site Number : 8401287

Doral, Florida, United States

Site Status

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

Fort Myers, Florida, United States

Site Status

Direct Helpers Research Center- Site Number : 8401056

Hialeah, Florida, United States

Site Status

Doral Medical Research - Hialeah- Site Number : 8401094

Hialeah, Florida, United States

Site Status

Clever Medical Research- Site Number : 8401160

Miami, Florida, United States

Site Status

Medical Research Center of Miami II- Site Number : 8401019

Miami, Florida, United States

Site Status

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, United States

Site Status

Sanchez Clinical Research- Site Number : 8401095

Miami, Florida, United States

Site Status

Future Care Solution - Miami- Site Number : 8401144

Miami, Florida, United States

Site Status

Florida International Research Center- Site Number : 8401091

Miami, Florida, United States

Site Status

Savin Medical Group - Miami Lakes- Site Number : 8401085

Miami Lakes, Florida, United States

Site Status

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

Miami Lakes, Florida, United States

Site Status

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

Orlando, Florida, United States

Site Status

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, United States

Site Status

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, United States

Site Status

Alliance Clinical Research of Tampa- Site Number : 8401013

Tampa, Florida, United States

Site Status

First Georgia Physician Group- Site Number : 8401190

Fayetteville, Georgia, United States

Site Status

Aeroallergy Research Laboratory- Site Number : 8401004

Savannah, Georgia, United States

Site Status

Northwestern University- Site Number : 8401038

Chicago, Illinois, United States

Site Status

Equity Medical - Bowling Green- Site Number : 8401296

Bowling Green, Kentucky, United States

Site Status

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, United States

Site Status

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

Baton Rouge, Louisiana, United States

Site Status

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, United States

Site Status

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, United States

Site Status

Revival Research Institute - Troy- Site Number : 8401012

Troy, Michigan, United States

Site Status

Oakland Medical Center- Site Number : 8401116

Troy, Michigan, United States

Site Status

Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078

Ypsilanti, Michigan, United States

Site Status

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

Ridgeland, Mississippi, United States

Site Status

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, United States

Site Status

Pulmonology Group - Henderson- Site Number : 8401169

Henderson, Nevada, United States

Site Status

The University of New Mexico- Site Number : 8401263

Albuquerque, New Mexico, United States

Site Status

Equity Medical- Site Number : 8401239

New York, New York, United States

Site Status

Skin Search Rochester- Site Number : 8401216

Rochester, New York, United States

Site Status

Axis Clinical Trials- Site Number : 8401196

Fargo, North Dakota, United States

Site Status

Best Skin Research - Camp Hill- Site Number : 8401031

Camp Hill, Pennsylvania, United States

Site Status

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, United States

Site Status

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, United States

Site Status

Dermatology Associates of Plymouth Meeting- Site Number : 8401147

Plymouth Meeting, Pennsylvania, United States

Site Status

Velocity Clinical Research - Columbia- Site Number : 8401176

Columbia, South Carolina, United States

Site Status

Health Concepts - Site Number : 8401059

Rapid City, South Dakota, United States

Site Status

Arlington Research Center- Site Number : 8401248

Arlington, Texas, United States

Site Status

Modern Research Associates- Site Number : 8401093

Dallas, Texas, United States

Site Status

Reveal Research Institute - Dallas- Site Number : 8401219

Dallas, Texas, United States

Site Status

SMS Clinical Research- Site Number : 8401182

Mesquite, Texas, United States

Site Status

Synapse Clinical Research - Missouri City- Site Number : 8401148

Missouri City, Texas, United States

Site Status

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, United States

Site Status

Complete Dermatology - Sugar Land- Site Number : 8401061

Sugar Land, Texas, United States

Site Status

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, United States

Site Status

Wyoming Research Foundation- Site Number : 8401234

Cheyenne, Wyoming, United States

Site Status

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Site Status

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Site Status

Investigational Site Number : 0320011

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320016

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320008

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320010

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320002

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320004

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320009

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320019

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320005

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320014

Córdoba, , Argentina

Site Status

Investigational Site Number : 0320013

Mendoza, , Argentina

Site Status

Investigational Site Number : 0360010

Westmead, New South Wales, Australia

Site Status

Investigational Site Number : 0360007

Woolloongabba, Queensland, Australia

Site Status

Investigational Site Number : 0363002

Carlton, Victoria, Australia

Site Status

Investigational Site Number : 0363003

Melbourne, Victoria, Australia

Site Status

Investigational Site Number : 0360006

Melbourne, Victoria, Australia

Site Status

Investigational Site Number : 0363001

Parkville, Victoria, Australia

Site Status

Investigational Site Number : 0361006

Traralgon, Victoria, Australia

Site Status

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

Site Status

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

Curitiba, Paraná, Brazil

Site Status

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo, Brazil

Site Status

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, Brazil

Site Status

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

Rio de Janeiro, , Brazil

Site Status

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

São Paulo, , Brazil

Site Status

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

São Paulo, , Brazil

Site Status

Investigational Site Number : 1002004

Pleven, , Bulgaria

Site Status

Investigational Site Number : 1002005

Sofia, , Bulgaria

Site Status

Investigational Site Number : 1002003

Sofia, , Bulgaria

Site Status

Investigational Site Number : 1002006

Sofia, , Bulgaria

Site Status

Investigational Site Number : 1002002

Sofia, , Bulgaria

Site Status

Investigational Site Number : 1240039

Calgary, Alberta, Canada

Site Status

Investigational Site Number : 1240019

Calgary, Alberta, Canada

Site Status

Investigational Site Number : 1240023

Calgary, Alberta, Canada

Site Status

Investigational Site Number : 1240016

Edmonton, Alberta, Canada

Site Status

Investigational Site Number : 1240031

Edmonton, Alberta, Canada

Site Status

Investigational Site Number : 1240040

Surrey, British Columbia, Canada

Site Status

Investigational Site Number : 1240041

Winnipeg, Manitoba, Canada

Site Status

Investigational Site Number : 1240033

Ajax, Ontario, Canada

Site Status

Investigational Site Number : 1240014

Barrie, Ontario, Canada

Site Status

Investigational Site Number : 1240020

Hamilton, Ontario, Canada

Site Status

Investigational Site Number : 1240053

London, Ontario, Canada

Site Status

Investigational Site Number : 1240017

London, Ontario, Canada

Site Status

Investigational Site Number : 1241106

Markham, Ontario, Canada

Site Status

Investigational Site Number : 1240018

Newmarket, Ontario, Canada

Site Status

Investigational Site Number : 1241108

Niagara Falls, Ontario, Canada

Site Status

Investigational Site Number : 1240034

Ottawa, Ontario, Canada

Site Status

Investigational Site Number : 1240024

Richmond Hill, Ontario, Canada

Site Status

Investigational Site Number : 1240021

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1240012

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1240026

Toronto, Ontario, Canada

Site Status

Investigational Site Number: 1240035

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1241107

Waterloo, Ontario, Canada

Site Status

Investigational Site Number : 1241101

Windsor, Ontario, Canada

Site Status

Investigational Site Number : 1240006

Québec, Quebec, Canada

Site Status

Investigational Site Number: 1240028

Regina, Saskatchewan, Canada

Site Status

Investigational Site Number : 1240036

Saskatoon, Saskatchewan, Canada

Site Status

Investigational Site Number : 1520004

Valdivia, Los Ríos Region, Chile

Site Status

Investigational Site Number : 1520013

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520010

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1560004

Beijing, , China

Site Status

Investigational Site Number : 1560050

Changsha, , China

Site Status

Investigational Site Number : 1560022

Chengdu, , China

Site Status

Investigational Site Number : 1560043

Fuzhou, , China

Site Status

Investigational Site Number : 1560021

Guangzhou, , China

Site Status

Investigational Site Number : 1560025

Guangzhou, , China

Site Status

Investigational Site Number : 1560036

Guangzhou, , China

Site Status

Investigational Site Number : 1560058

Guangzhou, , China

Site Status

Investigational Site Number : 1560044

Hangzhou, , China

Site Status

Investigational Site Number : 1560002

Hangzhou, , China

Site Status

Investigational Site Number : 1560006

Hangzhou, , China

Site Status

Investigational Site Number : 1560029

Hangzhou, , China

Site Status

Investigational Site Number : 1560024

Ningbo, , China

Site Status

Investigational Site Number : 1560035

Ningbo, , China

Site Status

Investigational Site Number : 1560001

Shanghai, , China

Site Status

Investigational Site Number : 1560041

Shenyang, , China

Site Status

Investigational Site Number : 1560026

Shenyang, , China

Site Status

Investigational Site Number : 1560023

Wenzhou, , China

Site Status

Investigational Site Number : 1560038

Wuhan, , China

Site Status

Investigational Site Number : 1560003

Wuxi, , China

Site Status

Investigational Site Number : 1560028

Zhenjiang, , China

Site Status

Investigational Site Number : 2032108

Brno, , Czechia

Site Status

Investigational Site Number : 2032106

Kutná Hora, , Czechia

Site Status

Investigational Site Number : 2032105

Nový Jičín, , Czechia

Site Status

Investigational Site Number : 2030010

Olomouc, , Czechia

Site Status

Investigational Site Number : 2032104

Ostrava, , Czechia

Site Status

Investigational Site Number : 2030009

Pilsen, , Czechia

Site Status

Investigational Site Number : 2032102

Prague, , Czechia

Site Status

Investigational Site Number : 2030008

Prague, , Czechia

Site Status

Investigational Site Number : 2032101

Prague, , Czechia

Site Status

Investigational Site Number : 2032103

Prague, , Czechia

Site Status

Investigational Site Number : 2030011

Prague, , Czechia

Site Status

Investigational Site Number : 2030006

Prague, , Czechia

Site Status

Investigational Site Number : 2500008

Antony, , France

Site Status

Investigational Site Number : 2500011

Bordeaux, , France

Site Status

Investigational Site Number : 2500014

Clermont-Ferrand, , France

Site Status

Investigational Site Number : 2500001

Lille, , France

Site Status

Investigational Site Number : 2500012

Rouen, , France

Site Status

Investigational Site Number : 2760009

Bad Bentheim, , Germany

Site Status

Investigational Site Number : 2762203

Berlin, , Germany

Site Status

Investigational Site Number : 2762202

Blankenfelde-Mahlow, , Germany

Site Status

Investigational Site Number : 2761001

Dresden, , Germany

Site Status

Investigational Site Number : 2762207

Gera, , Germany

Site Status

Investigational Site Number : 2760017

Hamburg, , Germany

Site Status

Investigational Site Number : 2762208

Kiel, , Germany

Site Status

Investigational Site Number : 2761002

Lübeck, , Germany

Site Status

Investigational Site Number : 2762201

Münster, , Germany

Site Status

Investigational Site Number : 3000001

Athens, , Greece

Site Status

Investigational Site Number : 3482303

Debrecen, , Hungary

Site Status

Investigational Site Number : 3482306

Szolnok, , Hungary

Site Status

Investigational Site Number : 3760005

Beersheba, , Israel

Site Status

Investigational Site Number : 3760003

Jerusalem, , Israel

Site Status

Investigational Site Number : 3760007

Tel Aviv, , Israel

Site Status

Investigational Site Number : 3760008

Tel Litwinsky, , Israel

Site Status

Investigational Site Number : 3800017

Naples, Napoli, Italy

Site Status

Investigational Site Number : 3800016

Chieti, , Italy

Site Status

Investigational Site Number : 3800021

Modena, , Italy

Site Status

Investigational Site Number : 3800015

Perugia, , Italy

Site Status

Investigational Site Number : 3800020

Torino, , Italy

Site Status

Investigational Site Number : 3920007

Hiroshima, Hiroshima, Japan

Site Status

Investigational Site Number : 3923114

Obihiro-Shi, Hokkaido, Japan

Site Status

Investigational Site Number : 3923101

Sapporo, Hokkaido, Japan

Site Status

Investigational Site Number : 3920006

Kobe, Hyōgo, Japan

Site Status

Investigational Site Number : 3923108

Kagoshima, Kagoshima-ken, Japan

Site Status

Investigational Site Number : 3920005

Sagamihara-shi, Kanagawa, Japan

Site Status

Investigational Site Number : 3923113

Yokohama, Kanagawa, Japan

Site Status

Investigational Site Number : 3920003

Kyoto, Kyoto, Japan

Site Status

Investigational Site Number : 3923110

Sakai-shi, Osaka, Japan

Site Status

Investigational Site Number : 3920002

Iruma-gun, Saitama, Japan

Site Status

Investigational Site Number : 3923106

Shimotsuga-gun, Tochigi, Japan

Site Status

Investigational Site Number : 3923112

Adachi-Ku, Tokyo, Japan

Site Status

Investigational Site Number : 3923115

Chuo-Ku, Tokyo, Japan

Site Status

Investigational Site Number : 3923104

Edogawa-Ku, Tokyo, Japan

Site Status

Investigational Site Number : 3923107

Minato-Ku, Tokyo, Japan

Site Status

Investigational Site Number : 3923105

Setagaya-Ku, Tokyo, Japan

Site Status

Investigational Site Number : 3920001

Tachikawa-shi, Tokyo, Japan

Site Status

Investigational Site Number : 3923109

Habikino-shi, , Japan

Site Status

Investigational Site Number : 3923102

Kyoto, , Japan

Site Status

Investigational Site Number : 3923113

Yokohama, , Japan

Site Status

Investigational Site Number : 6162407

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Investigational Site Number : 6162409

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Investigational Site Number : 6162406

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Investigational Site Number: 6160010

Tarnów, Lesser Poland Voivodeship, Poland

Site Status

Investigational Site Number : 6162414

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Investigational Site Number : 6162418

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Investigational Site Number : 6162417

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Investigational Site Number : 6162415

Lodz, Lódzkie, Poland

Site Status

Investigational Site Number : 6162416

Lódz, Lódzkie, Poland

Site Status

Investigational Site Number : 6162411

Warsaw, Masovian Voivodeship, Poland

Site Status

Investigational Site Number : 6162413

Warsaw, Masovian Voivodeship, Poland

Site Status

Investigational Site Number : 6162401

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status

Investigational Site Number : 6162419

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Investigational Site Number : 6162403

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number : 6162402

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number : 6160006

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number : 6162404

Gdynia, Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number : 6162405

Katowice, Silesian Voivodeship, Poland

Site Status

Investigational Site Number : 6162410

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Investigational Site Number : 6162408

Krakow, , Poland

Site Status

Investigational Site Number : 6160022

Lodz, , Poland

Site Status

Investigational Site Number : 6162412

Warsaw, , Poland

Site Status

Investigational Site Number : 6200004

Lisbon, , Portugal

Site Status

Investigational Site Number : 6200001

Lisbon, , Portugal

Site Status

Investigational Site Number : 6200003

Porto, , Portugal

Site Status

Investigational Site Number : 6820001

Riyadh, , Saudi Arabia

Site Status

Investigational Site Number : 7100015

Benoni, , South Africa

Site Status

Investigational Site Number : 7100010

Cape Town, , South Africa

Site Status

Investigational Site Number: 7100009

Claremont, , South Africa

Site Status

Investigational Site Number : 7100012

Durban, , South Africa

Site Status

Investigational Site Number : 7100001

Durban, , South Africa

Site Status

Investigational Site Number : 4100012

Gwangju, Gwangju, South Korea

Site Status

Investigational Site Number : 4100002

Ansan-si, Gyeonggi-do, South Korea

Site Status

Investigational Site Number : 4100009

Suwon, Gyeonggi-do, South Korea

Site Status

Investigational Site Number : 4100003

Yangsan, Gyeongsangnam-do, South Korea

Site Status

Investigational Site Number : 4100015

Incheon, Incheon-gwangyeoksi, South Korea

Site Status

Investigational Site Number : 4100013

Seoul, Seoul-teukbyeolsi, South Korea

Site Status

Investigational Site Number : 4100007

Seoul, Seoul-teukbyeolsi, South Korea

Site Status

Investigational Site Number : 4100010

Seoul, Seoul-teukbyeolsi, South Korea

Site Status

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, South Korea

Site Status

Investigational Site Number : 4100011

Seoul, Seoul-teukbyeolsi, South Korea

Site Status

Investigational Site Number : 4100008

Daegu, , South Korea

Site Status

Investigational Site Number : 7240012

Las Palmas de Gran Canaria, Canary Islands, Spain

Site Status

Investigational Site Number : 7240002

Badalona, Catalunya [Cataluña], Spain

Site Status

Investigational Site Number : 7242504

Pontevedra, Galicia [Galicia], Spain

Site Status

Investigational Site Number : 7240023

Burjassot - Valencia, Valenciana, Comunidad, Spain

Site Status

Investigational Site Number : 7242505

Alicante, , Spain

Site Status

Investigational Site Number : 7242501

Córdoba, , Spain

Site Status

Investigational Site Number : 7240018

Granada, , Spain

Site Status

Investigational Site Number : 7242503

Madrid, , Spain

Site Status

Investigational Site Number : 1583201

Kaohsiung City, , Taiwan

Site Status

Investigational Site Number : 1583202

Taichung, , Taiwan

Site Status

Investigational Site Number : 1580001

Taipei, , Taiwan

Site Status

Investigational Site Number : 1583203

Taoyuan, , Taiwan

Site Status

Investigational Site Number : 7920005

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920004

Kayseri, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920008

Şahinbey, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7840001

Abu Dhabi, , United Arab Emirates

Site Status

Investigational Site Number : 8260013

Bristol, Bristol, City of, United Kingdom

Site Status

Investigational Site Number : 8260006

Glasgow, Glasgow City, United Kingdom

Site Status

Investigational Site Number : 8260003

Portsmouth, Hampshire, United Kingdom

Site Status

Investigational Site Number : 8260004

Leicester, Leicestershire, United Kingdom

Site Status

Investigational Site Number : 8262603

London, London, City of, United Kingdom

Site Status

Investigational Site Number : 8262601

London, London, City of, United Kingdom

Site Status

Investigational Site Number : 8260010

Sutton in Ashfield, Nottinghamshire, United Kingdom

Site Status

Investigational Site Number : 8260008

Liverpool, , United Kingdom

Site Status

Countries

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United States Argentina Australia Brazil Bulgaria Canada Chile China Czechia France Germany Greece Hungary Israel Italy Japan Poland Portugal Saudi Arabia South Africa South Korea Spain Taiwan Turkey (Türkiye) United Arab Emirates United Kingdom

Related Links

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Other Identifiers

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U1111-1269-6490

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-506548-18

Identifier Type: REGISTRY

Identifier Source: secondary_id

KY1005-CT06

Identifier Type: OTHER

Identifier Source: secondary_id

2021-002344-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LTS17367

Identifier Type: -

Identifier Source: org_study_id

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