A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

NCT ID: NCT06407934

Last Updated: 2025-11-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2027-03-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD).

The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 \[COAST-1\], EFC17560 \[COAST 2\], EFC17561 \[SHORE\]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal.

Study details include:

The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD).

The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY).

The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \[RIVER-AD\] study).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dermatitis Atopic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amlitelimab dose 1

Subcutaneous injection as per protocol

Group Type EXPERIMENTAL

Amlitelimab

Intervention Type DRUG

Pharmaceutical form: Injection solution

Route of administration: Subcutaneous (SC) injection

Amlitelimab dose 2

Subcutaneous injection as per protocol

Group Type EXPERIMENTAL

Amlitelimab

Intervention Type DRUG

Pharmaceutical form: Injection solution

Route of administration: Subcutaneous (SC) injection

Placebo

Subcutaneous injection as per protocol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pharmaceutical form: Injection solution

Route of administration: SC injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amlitelimab

Pharmaceutical form: Injection solution

Route of administration: Subcutaneous (SC) injection

Intervention Type DRUG

Placebo

Pharmaceutical form: Injection solution

Route of administration: SC injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SAR445229

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
* Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
* Able and willing to comply with requested study visit and procedures.
* Body weight must be ≥ 25 kg.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

* Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
* Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
* Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
* Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cahaba Dermatology & Skin Health Center- Site Number : 8401066

Birmingham, Alabama, United States

Site Status RECRUITING

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, United States

Site Status RECRUITING

Scottsdale Clinical Trials- Site Number : 8401149

Scottsdale, Arizona, United States

Site Status RECRUITING

Eclipse Clinical Research- Site Number : 8401158

Tucson, Arizona, United States

Site Status RECRUITING

Johnson Dermatology- Site Number : 8401076

Fort Smith, Arkansas, United States

Site Status RECRUITING

Encino Research Center- Site Number : 8401042

Encino, California, United States

Site Status RECRUITING

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, United States

Site Status RECRUITING

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, United States

Site Status RECRUITING

Marvel Clinical Research- Site Number : 8401102

Huntington Beach, California, United States

Site Status RECRUITING

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, United States

Site Status RECRUITING

Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027

Lomita, California, United States

Site Status RECRUITING

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California, United States

Site Status RECRUITING

LA Universal Research Center- Site Number : 8401064

Los Angeles, California, United States

Site Status RECRUITING

Northridge Clinical Trials - Northridge- Site Number : 8401080

Northridge, California, United States

Site Status RECRUITING

Cura Clinical Research - Oxnard- Site Number : 8401142

Oxnard, California, United States

Site Status RECRUITING

Southern California Dermatology- Site Number : 8401043

Santa Ana, California, United States

Site Status RECRUITING

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, United States

Site Status RECRUITING

UConn Health - Farmington- Site Number : 8401115

Farmington, Connecticut, United States

Site Status RECRUITING

Pediatric Skin Research- Site Number : 8401198

Coral Gables, Florida, United States

Site Status RECRUITING

St. Jude Clinical Research- Site Number : 8401287

Doral, Florida, United States

Site Status RECRUITING

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

Fort Myers, Florida, United States

Site Status RECRUITING

Direct Helpers Research Center- Site Number : 8401056

Hialeah, Florida, United States

Site Status RECRUITING

Encore Medical Research - Hollywood- Site Number : 8401030

Hollywood, Florida, United States

Site Status RECRUITING

Clever Medical Research- Site Number : 8401160

Miami, Florida, United States

Site Status RECRUITING

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, United States

Site Status RECRUITING

Florida International Research Center- Site Number : 8401091

Miami, Florida, United States

Site Status RECRUITING

Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086

Miami, Florida, United States

Site Status RECRUITING

Anchor Medical Research- Site Number : 8401300

Miami, Florida, United States

Site Status RECRUITING

Savin Medical Group - Miami Lakes- Site Number : 8401085

Miami Lakes, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Nuline Clinical Trial Center- Site Number : 8401161

Pompano Beach, Florida, United States

Site Status RECRUITING

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, United States

Site Status RECRUITING

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, United States

Site Status RECRUITING

AllerVie Clinical Research - Columbus- Site Number : 8401104

Columbus, Georgia, United States

Site Status RECRUITING

Cleaver Medical Group- Site Number : 8401138

Dawsonville, Georgia, United States

Site Status RECRUITING

First Georgia Physician Group- Site Number : 8401190

Fayetteville, Georgia, United States

Site Status RECRUITING

Skin Care Physicians of Georgia - Macon- Site Number : 8401034

Macon, Georgia, United States

Site Status RECRUITING

Javara Research - Thomasville- Site Number : 8401189

Thomasville, Georgia, United States

Site Status RECRUITING

Rophe Adult & Pediatric Medicine- Site Number : 8401289

Union City, Georgia, United States

Site Status RECRUITING

NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038

Skokie, Illinois, United States

Site Status RECRUITING

Dawes Fretzin Clinical Research- Site Number : 8401015

Indianapolis, Indiana, United States

Site Status RECRUITING

Equity Medical - Bowling Green- Site Number : 8401296

Bowling Green, Kentucky, United States

Site Status RECRUITING

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, United States

Site Status RECRUITING

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, United States

Site Status RECRUITING

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, United States

Site Status RECRUITING

Velocity Clinical Research - Lafayette- Site Number : 8401152

Lafayette, Louisiana, United States

Site Status RECRUITING

MetroBoston Clinical Partners - Brighton- Site Number : 8401128

Brighton, Massachusetts, United States

Site Status RECRUITING

Henry Ford Hospital- Site Number : 8401044

Detroit, Michigan, United States

Site Status RECRUITING

Revival Research Institute - Troy- Site Number : 8401012

Troy, Michigan, United States

Site Status RECRUITING

Oakland Medical Center- Site Number : 8401116

Troy, Michigan, United States

Site Status RECRUITING

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

Ypsilanti, Michigan, United States

Site Status RECRUITING

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

Ridgeland, Mississippi, United States

Site Status RECRUITING

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, United States

Site Status RECRUITING

Jubilee Clinical Research- Site Number : 8401054

Las Vegas, Nevada, United States

Site Status RECRUITING

Care Access - Hoboken- Site Number : 8401132

Hoboken, New Jersey, United States

Site Status RECRUITING

The University of New Mexico- Site Number : 8401263

Albuquerque, New Mexico, United States

Site Status RECRUITING

Equity Medical- Site Number : 8401239

New York, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai- Site Number : 8401129

New York, New York, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status RECRUITING

OptiSkin- Site Number : 8401163

New York, New York, United States

Site Status RECRUITING

AXIS Clinicals - Fargo- Site Number : 8401196

Fargo, North Dakota, United States

Site Status RECRUITING

Bexley Dermatology Research- Site Number : 8401051

Bexley, Ohio, United States

Site Status RECRUITING

Apex Clinical Research Center- Site Number : 8401237

Mayfield Heights, Ohio, United States

Site Status RECRUITING

Oregon Medical Research Center- Site Number : 8401017

Portland, Oregon, United States

Site Status RECRUITING

Best Skin Research - Camp Hill- Site Number : 8401031

Camp Hill, Pennsylvania, United States

Site Status RECRUITING

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Dermatology Associates of Plymouth Meeting- Site Number : 8401147

Plymouth Meeting, Pennsylvania, United States

Site Status RECRUITING

Columbia Dermatology & Aesthetics- Site Number : 8401166

Columbia, South Carolina, United States

Site Status RECRUITING

Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8401225

Greenville, South Carolina, United States

Site Status RECRUITING

Health Concepts- Site Number : 8401059

Rapid City, South Dakota, United States

Site Status RECRUITING

Arlington Research Center- Site Number : 8401248

Arlington, Texas, United States

Site Status RECRUITING

Dermatology Treatment and Research Center- Site Number : 8401164

Dallas, Texas, United States

Site Status RECRUITING

Derm Texas- Site Number : 8401217

Dallas, Texas, United States

Site Status RECRUITING

Prolato Clinical Research Center- Site Number : 8401209

Houston, Texas, United States

Site Status RECRUITING

SMS Clinical Research- Site Number : 8401182

Mesquite, Texas, United States

Site Status RECRUITING

Synapse Clinical Research - Missouri City- Site Number : 8401148

Missouri City, Texas, United States

Site Status RECRUITING

Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8401131

San Antonio, Texas, United States

Site Status RECRUITING

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, United States

Site Status RECRUITING

Complete Dermatology - Sugar Land- Site Number : 8401061

Sugar Land, Texas, United States

Site Status RECRUITING

Tanner Clinic - Layton Antelope A- Site Number : 8401151

Layton, Utah, United States

Site Status RECRUITING

Care Access - Arlington- Site Number : 8401134

Arlington, Virginia, United States

Site Status RECRUITING

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, United States

Site Status RECRUITING

Investigational Site Number : 0320021

Berazategui, Buenos Aires, Argentina

Site Status RECRUITING

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Investigational Site Number : 0320015

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Investigational Site Number : 0320020

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status RECRUITING

Investigational Site Number : 0320024

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status RECRUITING

Investigational Site Number : 0320022

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320023

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320011

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320016

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320008

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320001

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320018

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320010

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320002

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320004

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320009

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320019

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320005

Buenos Aires, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320012

Corrientes, , Argentina

Site Status RECRUITING

Investigational Site Number : 0320013

Mendoza, , Argentina

Site Status RECRUITING

Investigational Site Number : 0360010

Westmead, New South Wales, Australia

Site Status RECRUITING

Investigational Site Number : 0360007

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Investigational Site Number : 0360008

Melbourne, Victoria, Australia

Site Status RECRUITING

Investigational Site Number : 0360006

Melbourne, Victoria, Australia

Site Status RECRUITING

Investigational Site Number : 0361006

Traralgon, Victoria, Australia

Site Status RECRUITING

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

Vitória, Espírito Santo, Brazil

Site Status RECRUITING

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Hospital São Domingos- Site Number : 0760028

Bequimão, Maranhão, Brazil

Site Status RECRUITING

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

Curitiba, Paraná, Brazil

Site Status RECRUITING

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

Curitiba, Paraná, Brazil

Site Status RECRUITING

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

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

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo, Brazil

Site Status RECRUITING

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, Brazil

Site Status RECRUITING

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

Rio de Janeiro, , Brazil

Site Status RECRUITING

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

São Paulo, , Brazil

Site Status RECRUITING

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

São Paulo, , Brazil

Site Status RECRUITING

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

São Paulo, , Brazil

Site Status RECRUITING

Investigational Site Number : 1002007

Dupnitsa, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1002004

Pleven, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1002005

Sofia, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1240039

Calgary, Alberta, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240031

Edmonton, Alberta, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240045

Red Deer, Alberta, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240046

Kelowna, British Columbia, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240040

Surrey, British Columbia, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240030

Surrey, British Columbia, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240041

Winnipeg, Manitoba, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240033

Ajax, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240029

London, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1241106

Markham, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240008

Mississauga, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1241108

Niagara Falls, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240034

Ottawa, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240038

Richmond Hill, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240012

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240035

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1241107

Waterloo, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240006

Québec, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240028

Regina, Saskatchewan, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1240036

Saskatoon, Saskatchewan, Canada

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1520004

Valdivia, Los Ríos Region, Chile

Site Status RECRUITING

Investigational Site Number : 1520009

Osorno, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520013

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520014

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520010

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520011

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520015

Quillota, Región de Valparaíso, Chile

Site Status RECRUITING

Investigational Site Number : 1520006

Viña del Mar, Región de Valparaíso, Chile

Site Status RECRUITING

Investigational Site Number : 1520012

Talcahuano, Región del Biobío, Chile

Site Status RECRUITING

Investigational Site Number : 1560042

Beijing, , China

Site Status RECRUITING

Investigational Site Number : 1560004

Beijing, , China

Site Status RECRUITING

Investigational Site Number : 1560030

Beijing, , China

Site Status RECRUITING

Investigational Site Number : 1560050

Changsha, , China

Site Status RECRUITING

Investigational Site Number : 1560022

Chengdu, , China

Site Status RECRUITING

Investigational Site Number : 1560060

Chengdu, , China

Site Status RECRUITING

Investigational Site Number : 1560068

Chengdu, , China

Site Status RECRUITING

Investigational Site Number : 1560057

Chongqing, , China

Site Status RECRUITING

Investigational Site Number : 1560065

Chongqing, , China

Site Status RECRUITING

Investigational Site Number : 1560043

Fuzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560021

Guangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560025

Guangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560058

Guangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560044

Hangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560002

Hangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560006

Hangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560029

Hangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560007

Jinan, , China

Site Status RECRUITING

Investigational Site Number : 1560051

Nanchang, , China

Site Status RECRUITING

Investigational Site Number : 1560024

Ningbo, , China

Site Status RECRUITING

Investigational Site Number : 1560001

Shanghai, , China

Site Status RECRUITING

Investigational Site Number : 1560005

Shanghai, , China

Site Status RECRUITING

Investigational Site Number : 1560041

Shenyang, , China

Site Status RECRUITING

Investigational Site Number : 1560026

Shenyang, , China

Site Status RECRUITING

Investigational Site Number : 1560064

Shenzhen, , China

Site Status RECRUITING

Investigational Site Number : 1560023

Wenzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560049

Wuhan, , China

Site Status RECRUITING

Investigational Site Number : 1560003

Wuxi, , China

Site Status RECRUITING

Investigational Site Number : 1560028

Zhenjiang, , China

Site Status RECRUITING

Investigational Site Number : 2032106

Kutná Hora, , Czechia

Site Status RECRUITING

Investigational Site Number : 2032105

Nový Jičín, , Czechia

Site Status RECRUITING

Investigational Site Number : 2030010

Olomouc, , Czechia

Site Status RECRUITING

Investigational Site Number : 2032104

Ostrava, , Czechia

Site Status RECRUITING

Investigational Site Number : 2030009

Pilsen, , Czechia

Site Status RECRUITING

Investigational Site Number : 2030008

Prague, , Czechia

Site Status RECRUITING

Investigational Site Number : 2030011

Prague, , Czechia

Site Status RECRUITING

Investigational Site Number : 2030006

Prague, , Czechia

Site Status RECRUITING

Investigational Site Number : 2080002

Aalborg, , Denmark

Site Status RECRUITING

Investigational Site Number : 2080001

Aarhus, , Denmark

Site Status RECRUITING

Investigational Site Number : 2080003

Herlev, , Denmark

Site Status RECRUITING

Investigational Site Number : 2500008

Antony, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500013

Nice, , France

Site Status RECRUITING

Investigational Site Number : 2500003

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500006

Pierre-Bénite, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500007

Reims, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500010

Romans-sur-Isère, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500012

Rouen, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500002

Toulouse, , France

Site Status RECRUITING

Investigational Site Number : 2760020

Augsburg, , Germany

Site Status RECRUITING

Investigational Site Number : 2760009

Bad Bentheim, , Germany

Site Status RECRUITING

Investigational Site Number : 2760017

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number : 2760021

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number : 2762208

Kiel, , Germany

Site Status RECRUITING

Investigational Site Number : 2760016

Mainz, , Germany

Site Status RECRUITING

Investigational Site Number : 2762201

Münster, , Germany

Site Status RECRUITING

Investigational Site Number : 2760019

Witten, , Germany

Site Status RECRUITING

Investigational Site Number : 3000001

Athens, , Greece

Site Status RECRUITING

Investigational Site Number : 3000002

Thessaloniki, , Greece

Site Status RECRUITING

Investigational Site Number : 3560001

Ahmedabad, , India

Site Status RECRUITING

Investigational Site Number : 3560005

Belagavi, , India

Site Status RECRUITING

Investigational Site Number : 3560004

Chandigarh, , India

Site Status RECRUITING

Investigational Site Number : 3560006

Faridabad, , India

Site Status RECRUITING

Investigational Site Number : 3560007

Kolkata, , India

Site Status RECRUITING

Investigational Site Number : 3560002

Nagpur, , India

Site Status RECRUITING

Investigational Site Number : 3560003

Pune, , India

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3760004

Afula, , Israel

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3760005

Beersheba, , Israel

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3760001

Haifa, , Israel

Site Status COMPLETED

Investigational Site Number : 3760003

Jerusalem, , Israel

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3760006

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3760002

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800003

Milan, Milano, Italy

Site Status RECRUITING

Investigational Site Number : 3800018

Rozzano, Milano, Italy

Site Status RECRUITING

Investigational Site Number : 3800013

Rome, Roma, Italy

Site Status RECRUITING

Investigational Site Number : 3800012

Bologna, , Italy

Site Status RECRUITING

Investigational Site Number : 3800009

Catania, , Italy

Site Status RECRUITING

Investigational Site Number : 3800011

L’Aquila, , Italy

Site Status RECRUITING

Investigational Site Number : 3800008

Pisa, , Italy

Site Status RECRUITING

Investigational Site Number : 3800022

Vicenza, , Italy

Site Status RECRUITING

Investigational Site Number : 3920009

Chitose, Hokkaido, Japan

Site Status RECRUITING

Investigational Site Number : 3923114

Obihiro, Hokkaido, Japan

Site Status RECRUITING

Investigational Site Number : 3920008

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Investigational Site Number : 3920006

Kobe, Hyōgo, Japan

Site Status RECRUITING

Investigational Site Number : 3920005

Sagamihara, Kanagawa, Japan

Site Status RECRUITING

Investigational Site Number : 3923113

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Investigational Site Number : 3920010

Miyagi-gun, Miyagi, Japan

Site Status RECRUITING

Investigational Site Number : 3920011

Sendai, Miyagi, Japan

Site Status RECRUITING

Investigational Site Number : 3923109

Habikino, Osaka, Japan

Site Status RECRUITING

Investigational Site Number : 3923110

Sakai, Osaka, Japan

Site Status RECRUITING

Investigational Site Number : 3920002

Iruma, Saitama, Japan

Site Status RECRUITING

Investigational Site Number : 3923106

Mibu, Tochigi, Japan

Site Status RECRUITING

Investigational Site Number : 3920004

Chūō, Tokyo, Japan

Site Status RECRUITING

Investigational Site Number : 3923107

Minato, Tokyo, Japan

Site Status RECRUITING

Investigational Site Number : 3920001

Tachikawa, Tokyo, Japan

Site Status RECRUITING

Investigational Site Number : 3923108

Kagoshima, , Japan

Site Status RECRUITING

Investigational Site Number : 3923102

Kyoto, , Japan

Site Status RECRUITING

Investigational Site Number : 3920003

Kyoto, , Japan

Site Status RECRUITING

Investigational Site Number : 4840005

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Investigational Site Number : 4840012

Aguascalientes, , Mexico

Site Status RECRUITING

Investigational Site Number : 4840009

Durango, , Mexico

Site Status RECRUITING

Investigational Site Number : 4840003

Veracruz, , Mexico

Site Status RECRUITING

Investigational Site Number : 6162406

Krakow, Lesser Poland Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160010

Tarnów, Lesser Poland Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160004

Lublin, Lublin Voivodeship, Poland

Site Status RECRUITING

Investigational Site Number : 6160002

Lodz, Lódzkie, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160009

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Investigational Site Number : 6160007

Warsaw, Masovian Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160006

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Investigational Site Number : 6160003

Katowice, Silesian Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6200005

Lisbon, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6200004

Lisbon, , Portugal

Site Status RECRUITING

Investigational Site Number : 6200001

Lisbon, , Portugal

Site Status RECRUITING

Investigational Site Number : 6200003

Porto, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7100015

Benoni, , South Africa

Site Status RECRUITING

Investigational Site Number : 7100010

Cape Town, , South Africa

Site Status RECRUITING

Investigational Site Number : 7100009

Cape Town, , South Africa

Site Status RECRUITING

Investigational Site Number : 7100012

Durban, , South Africa

Site Status RECRUITING

Investigational Site Number : 7100001

Durban, , South Africa

Site Status RECRUITING

Investigational Site Number : 7100007

Johannesburg, , South Africa

Site Status RECRUITING

Investigational Site Number : 7100003

Pretoria, , South Africa

Site Status RECRUITING

Investigational Site Number : 4100008

Daegu, Daegu, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100012

Gwangju, Gwangju, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100002

Ansan-si, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100014

Seongnam-si, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100009

Suwon, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100003

Yangsan, Gyeongsangnam-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100015

Bupyeong-gu, Incheon-gwangyeoksi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100010

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100013

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100007

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100011

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100017

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240010

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240008

Bilbao, Basque Country, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240012

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240015

Pamplona, Navarre, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240014

Vigo, Pontevedra [Pontevedra], Spain

Site Status RECRUITING

Investigational Site Number : 7240020

Seville, Sevilla, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240023

Burjassot - Valencia, Valenciana, Comunidad, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7242505

Alicante, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240018

Granada, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240019

Granada, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240029

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7242503

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7520006

Älvsjö, , Sweden

Site Status RECRUITING

Investigational Site Number : 7520001

Örebro, , Sweden

Site Status RECRUITING

Investigational Site Number : 1583201

Kaohsiung City, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1583202

Taichung, , Taiwan

Site Status RECRUITING

Investigational Site Number : 1580001

Taipei, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1580003

Taipei, , Taiwan

Site Status RECRUITING

Investigational Site Number : 7920001

Antalya, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920008

Gaziantep, , Turkey (Türkiye)

Site Status RECRUITING

Investigational Site Number : 7920005

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920006

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920002

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920009

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920004

Kayseri, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920011

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Investigational Site Number : 7920007

Samsun, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260003

Portsmouth, Hampshire, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8260004

Leicester, Leicestershire, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8262601

London, London, City of, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8262602

London, London, City of, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8260006

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria Colombia Croatia Ireland Malaysia Netherlands Peru Singapore Slovakia Tunisia United States Argentina Australia Brazil Bulgaria Canada Chile China Czechia Denmark France Germany Greece India Israel Italy Japan Mexico Poland Portugal South Africa South Korea Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Trial Transparency email recommended (Toll free for US & Canada)

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1290-9215

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-508096-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

EFC17600

Identifier Type: -

Identifier Source: org_study_id