Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

NCT ID: NCT06141486

Last Updated: 2026-01-16

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-27

Study Completion Date

2028-03-24

Brief Summary

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The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include:

* This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
* The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.
* If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Frexalimab

Frexalimab IV administration

Group Type EXPERIMENTAL

Frexalimab

Intervention Type DRUG

SAR441344 Solution for IV infusion

MRI contrast-enhancing agents

Intervention Type DRUG

IV, as per respective label

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution for IV infusion

MRI contrast-enhancing agents

Intervention Type DRUG

IV, as per respective label

Interventions

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Frexalimab

SAR441344 Solution for IV infusion

Intervention Type DRUG

Placebo

Solution for IV infusion

Intervention Type DRUG

MRI contrast-enhancing agents

IV, as per respective label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
* Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
* Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
* Absence of clinical relapses for at least 24 months.
* The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

Exclusion Criteria

* The participant has a history of infection or may be at risk for infection.
* The presence of psychiatric disturbance or substance abuse.
* History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
* Current hypogammaglobulinemia defined by immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening.
* A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
* The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
* The participant was previously exposed to frexalimab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Alabama Neurology Associates- Site Number : 8400115

Homewood, Alabama, United States

Site Status RECRUITING

St. Joseph's Hospital and Medical Center- Site Number : 8400139

Phoenix, Arizona, United States

Site Status RECRUITING

Honor Health Scottsdale Osborn Medical Center- Site Number : 8400074

Scottsdale, Arizona, United States

Site Status RECRUITING

Perseverance Research Center- Site Number : 8400138

Scottsdale, Arizona, United States

Site Status RECRUITING

Imaging Endpoints- Site Number : 8400050

Scottsdale, Arizona, United States

Site Status RECRUITING

Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134

Berkeley, California, United States

Site Status RECRUITING

The Neurology Center of Southern California - Carlsbad- Site Number : 8400023

Carlsbad, California, United States

Site Status RECRUITING

University of California Irvine - School of Medicine- Site Number : 8400143

Irvine, California, United States

Site Status RECRUITING

University of California San Diego - La Jolla- Site Number : 8400095

La Jolla, California, United States

Site Status RECRUITING

Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184

Los Angeles, California, United States

Site Status RECRUITING

University of Southern California, Los Angeles- Site Number : 8400118

Los Angeles, California, United States

Site Status RECRUITING

Hoag Memorial Hospital Presbyterian- Site Number : 8400031

Newport Beach, California, United States

Site Status RECRUITING

Stanford Neuroscience Health Center- Site Number : 8400120

Palo Alto, California, United States

Site Status RECRUITING

Private Practice - Dr. Regina Berkovich- Site Number : 8400005

West Hollywood, California, United States

Site Status RECRUITING

University of Colorado - Anschutz Medical Campus- Site Number : 8400001

Aurora, Colorado, United States

Site Status RECRUITING

Advanced Neurology of Colorado- Site Number : 8400148

Fort Collins, Colorado, United States

Site Status RECRUITING

Yale University School of Medicine- Site Number : 8400081

New Haven, Connecticut, United States

Site Status RECRUITING

Hartford Healthcare Medical Group- Site Number : 8400069

Norwich, Connecticut, United States

Site Status RECRUITING

New England Institute for Clinical Research- Site Number : 8400114

Stamford, Connecticut, United States

Site Status RECRUITING

MedStar Georgetown University Hospital- Site Number : 8400044

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Neurology of Central Florida- Site Number : 8400147

Altamonte Springs, Florida, United States

Site Status RECRUITING

First Choice Neurology - Espinosa Neuroscience Institute- Site Number : 8400169

Boca Raton, Florida, United States

Site Status RECRUITING

MS & Neuromuscular Center of Excellence- Site Number : 8400015

Clearwater, Florida, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400041

Fort Myers, Florida, United States

Site Status RECRUITING

Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054

Gainesville, Florida, United States

Site Status RECRUITING

Mayo Clinic in Florida- Site Number : 8400093

Jacksonville, Florida, United States

Site Status RECRUITING

Neurology Associates - Maitland- Site Number : 8400010

Maitland, Florida, United States

Site Status RECRUITING

University of Miami Hospital- Site Number : 8400177

Miami, Florida, United States

Site Status RECRUITING

Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060

Orlando, Florida, United States

Site Status RECRUITING

Axiom Clinical Research of Florida- Site Number : 8400049

Tampa, Florida, United States

Site Status RECRUITING

University of South Florida- Site Number : 8400013

Tampa, Florida, United States

Site Status RECRUITING

Palm Beach Neurology- Site Number : 8400105

West Palm Beach, Florida, United States

Site Status RECRUITING

Velocity Clinical Research - Savannah Neurology- Site Number : 8400061

Savannah, Georgia, United States

Site Status RECRUITING

Joi Life Wellness Group LLC- Site Number : 8400192

Smyrna, Georgia, United States

Site Status RECRUITING

Rush University Medical Center- Site Number : 8400102

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Medical Center- Site Number : 8400055

Chicago, Illinois, United States

Site Status RECRUITING

Consultants in Neurology- Site Number : 8400020

Northbrook, Illinois, United States

Site Status RECRUITING

Springfield Clinic 1st - 900 Building- Site Number : 8400043

Springfield, Illinois, United States

Site Status RECRUITING

Neuroscience Institute Center- Site Number : 8400053

Merrillville, Indiana, United States

Site Status RECRUITING

University of Iowa- Site Number : 8400029

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kansas Medical Center- Site Number : 8400084

Kansas City, Kansas, United States

Site Status RECRUITING

College Park Family Care Center - Specialty Center- Site Number : 8400032

Overland Park, Kansas, United States

Site Status RECRUITING

Baptist Health Lexington- Site Number : 8400149

Lexington, Kentucky, United States

Site Status RECRUITING

NeuroMedical Clinic of Central Louisiana- Site Number : 8400159

Alexandria, Louisiana, United States

Site Status RECRUITING

The NeuroMedical Center- Site Number : 8400182

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Ochsner Medical Center - Jefferson Highway- Site Number : 8400027

New Orleans, Louisiana, United States

Site Status RECRUITING

University of Maryland School of Medicine - Baltimore- Site Number : 8400185

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins Hospital- Site Number : 8400080

Baltimore, Maryland, United States

Site Status RECRUITING

International Neurorehabilitation Institute- Site Number : 8400089

Lutherville, Maryland, United States

Site Status RECRUITING

Tufts Medical Center- Site Number : 8400003

Boston, Massachusetts, United States

Site Status RECRUITING

Boston Clinical Trials- Site Number : 8400178

Boston, Massachusetts, United States

Site Status RECRUITING

Neurology Center of New England- Site Number : 8400164

Foxborough, Massachusetts, United States

Site Status RECRUITING

The Elliot Lewis Center- Site Number : 8400033

Wellesley, Massachusetts, United States

Site Status RECRUITING

UMass Memorial Medical Center - University Campus- Site Number : 8400028

Worcester, Massachusetts, United States

Site Status RECRUITING

Henry Ford Hospital- Site Number : 8400091

Detroit, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Michigan Institute for Neurological Disorders- Site Number : 8400004

Farmington Hills, Michigan, United States

Site Status RECRUITING

Trinity Health Grand Rapids- Site Number : 8400150

Grand Rapids, Michigan, United States

Site Status RECRUITING

Memorial Healthcare Institute for Neuroscience- Site Number : 8400123

Owosso, Michigan, United States

Site Status RECRUITING

Rochester Medical Group- Site Number : 8400172

Rochester Hills, Michigan, United States

Site Status RECRUITING

Minneapolis Clinic of Neurology - Golden Valley- Site Number : 8400077

Golden Valley, Minnesota, United States

Site Status RECRUITING

M Health Fairview University of Minnesota Medical Center - East Bank- Site Number : 8400056

Minneapolis, Minnesota, United States

Site Status RECRUITING

Minnesota Center for Multiple Sclerosis- Site Number : 8400073

Plymouth, Minnesota, United States

Site Status RECRUITING

Sharlin Health and Neurology- Site Number : 8400016

Ozark, Missouri, United States

Site Status RECRUITING

Washington University- Site Number : 8400076

St Louis, Missouri, United States

Site Status RECRUITING

Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas- Site Number : 8400045

Las Vegas, Nevada, United States

Site Status RECRUITING

Renown Regional Medical Center- Site Number : 8400066

Reno, Nevada, United States

Site Status RECRUITING

Dartmouth-Hitchcock Medical Center - Lebanon - 1 Medical Center Drive- Site Number : 8400098

Lebanon, New Hampshire, United States

Site Status RECRUITING

Rutgers University- Site Number : 8400067

New Brunswick, New Jersey, United States

Site Status RECRUITING

Holy Name Medical Center- Site Number : 8400101

Teaneck, New Jersey, United States

Site Status RECRUITING

The University of New Mexico- Site Number : 8400090

Albuquerque, New Mexico, United States

Site Status RECRUITING

Dent Neurologic Institute - Amherst- Site Number : 8400129

Amherst, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai- Site Number : 8400011

New York, New York, United States

Site Status RECRUITING

Columbia University Irving Medical Center- Site Number : 8400088

New York, New York, United States

Site Status RECRUITING

Stony Brook University- Site Number : 8400094

Stony Brook, New York, United States

Site Status RECRUITING

Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

Charlotte, North Carolina, United States

Site Status RECRUITING

Raleigh Neurology Associates- Site Number : 8400014

Raleigh, North Carolina, United States

Site Status RECRUITING

Atrium Health - Wake Forest Baptist - Shepherd- Site Number : 8400040

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Sanford Brain and Spine Center- Site Number : 8400085

Fargo, North Dakota, United States

Site Status RECRUITING

Riverhills Neuroscience- Site Number : 8400007

Cincinnati, Ohio, United States

Site Status RECRUITING

University of Cincinnati Medical Center- Site Number : 8400117

Cincinnati, Ohio, United States

Site Status RECRUITING

The Ohio State University- Site Number : 8400009

Columbus, Ohio, United States

Site Status RECRUITING

The Boster Center for Multiple Sclerosis- Site Number : 8400006

Columbus, Ohio, United States

Site Status RECRUITING

UC Health - Elizabeth Place- Site Number : 8400008

Dayton, Ohio, United States

Site Status RECRUITING

Oklahoma Medical Research Foundation- Site Number : 8400039

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Providence St. Vincent's Medical Center- Site Number : 8400052

Portland, Oregon, United States

Site Status RECRUITING

Penn State Health Milton South Hershey Medical Center- Site Number : 8400176

Hershey, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University Hospital- Site Number : 8400035

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Premier Neurology- Site Number : 8400047

Greer, South Carolina, United States

Site Status RECRUITING

Hope Neurology- Site Number : 8400019

Knoxville, Tennessee, United States

Site Status RECRUITING

Vanderbilt Multiple Sclerosis Center- Site Number : 8400130

Nashville, Tennessee, United States

Site Status RECRUITING

Neurology Consultants of Dallas - Lyndon B Johnson Freeway- Site Number : 8400152

Dallas, Texas, United States

Site Status RECRUITING

North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083

Plano, Texas, United States

Site Status RECRUITING

Neurology Center of San Antonio- Site Number : 8400099

San Antonio, Texas, United States

Site Status RECRUITING

Texas Institute for Neurological Disorders - Sherman- Site Number : 8400018

Sherman, Texas, United States

Site Status RECRUITING

University of Vermont Medical Center- Site Number : 8400042

Burlington, Vermont, United States

Site Status RECRUITING

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive- Site Number : 8400109

Fairfax, Virginia, United States

Site Status RECRUITING

Riverside Neurology Specialists - Newport News- Site Number : 8400132

Newport News, Virginia, United States

Site Status RECRUITING

Multiple Sclerosis Center of Greater Washington (MSCGW)- Site Number : 8400128

Vienna, Virginia, United States

Site Status RECRUITING

Sentara Family Medicine Physicians - Virginia Beach - Glenn Mitchell Drive- Site Number : 8400168

Virginia Beach, Virginia, United States

Site Status RECRUITING

Swedish Medical Center - Seattle- Site Number : 8400078

Seattle, Washington, United States

Site Status RECRUITING

West Virginia University School of Medicine- Site Number : 8400131

Morgantown, West Virginia, United States

Site Status RECRUITING

Wheaton Franciscan Healthcare - St Francis- Site Number : 8400034

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Investigational Site Number : 0320003

Rosario, Santa Fe Province, Argentina

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320002

Buenos Aires, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0321010

Buenos Aires, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320007

Buenos Aires, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320001

Buenos Aires, , Argentina

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0360005

Saint Leonards, New South Wales, Australia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0360001

Woolloongabba, Queensland, Australia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0360002

Melbourne, Victoria, Australia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0560001

Bruges, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0560008

Brussels, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0560006

Ghent, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0560007

Kortrijk, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0560003

Melsbroek, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 0560005

Overpelt, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760029

Vitória, Espírito Santo, Brazil

Site Status RECRUITING

Centro de Pesquisas da Clínica IBIS- Site Number : 0760030

Salvador, Estado de Bahia, Brazil

Site Status ACTIVE_NOT_RECRUITING

L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003

Brasília, Federal District, Brazil

Site Status ACTIVE_NOT_RECRUITING

Universidade Federal de Goias- Site Number : 0760024

Goiânia, Goiás, Brazil

Site Status ACTIVE_NOT_RECRUITING

Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760025

Belo Horizonte, Minas Gerais, Brazil

Site Status ACTIVE_NOT_RECRUITING

Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001

Curitiba, Paraná, Brazil

Site Status ACTIVE_NOT_RECRUITING

Hospital Moinhos de Vento- Site Number : 0760005

Porto Alegre, Rio Grande do Sul, Brazil

Site Status ACTIVE_NOT_RECRUITING

IMV Pesquisa Neurológica- Site Number : 0760031

Porto Alegre, Rio Grande do Sul, Brazil

Site Status ACTIVE_NOT_RECRUITING

Instituto Ceos- Site Number : 0760028

Porto Alegre, Rio Grande do Sul, Brazil

Site Status ACTIVE_NOT_RECRUITING

Clínica Neurológica- Site Number : 0760007

Joinville, Santa Catarina, Brazil

Site Status RECRUITING

Prognosis Centro de Pesquisa- Site Number : 0760032

Santo André, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

CPHosp Medicina, Ensino e Pesquisa (CPQuali)- Site Number : 0760002

São Paulo, , Brazil

Site Status ACTIVE_NOT_RECRUITING

PSEG Centro de Pesquisa Clínica- Site Number : 0760021

São Paulo, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Jordy Sinapse- Site Number : 0760004

São Paulo, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Hospital Israelita Albert Einstein- Site Number : 0760026

São Paulo, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1000009

Blagoevgrad, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000008

Panagyurishte, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000007

Pazardzhik, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000002

Pleven, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000010

Pleven, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000004

Sofia, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000001

Sofia, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000006

Sofia, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1000005

Sofia, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 1240011

Calgary, Alberta, Canada

Site Status RECRUITING

Investigational Site Number : 1240005

Burnaby, British Columbia, Canada

Site Status RECRUITING

Investigational Site Number : 1240010

Vancouver, British Columbia, Canada

Site Status RECRUITING

Investigational Site Number: 1240018

Moncton, New Brunswick, Canada

Site Status RECRUITING

Investigational Site Number : 1240014

London, Ontario, Canada

Site Status RECRUITING

Investigational Site Number : 1240002

Ottawa, Ontario, Canada

Site Status RECRUITING

Investigational Site Number : 1240015

Toronto, Ontario, Canada

Site Status RECRUITING

Investigational Site Number : 1240012

Toronto, Ontario, Canada

Site Status RECRUITING

Investigational Site Number : 1240001

Gatineau, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1240008

Lévis, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1240009

Montreal, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1240016

Pointe-Claire, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1240003

Québec, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1240006

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1520003

Las Condes, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560007

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560005

Beijing, , China

Site Status COMPLETED

Investigational Site Number : 1560008

Beijing, , China

Site Status COMPLETED

Investigational Site Number : 1560003

Changchun, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560011

Changsha, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560004

Chengdu, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560045

Fuzhou, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560002

Guangzhou, , China

Site Status COMPLETED

Investigational Site Number : 1561027

Harbin, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560010

Jiazhuang, , China

Site Status RECRUITING

Investigational Site Number : 1560001

Shanghai, , China

Site Status RECRUITING

Investigational Site Number : 1560006

Taiyuan, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560012

Tianjin, , China

Site Status RECRUITING

Investigational Site Number : 1560009

Wuhan, , China

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 1560013

Xi'an, , China

Site Status RECRUITING

Investigational Site Number : 1560034

Zhengzhou, , China

Site Status RECRUITING

Investigational Site Number : 2030011

Brno, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2030005

Brno, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2030002

Hradec Králové, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2030006

Jihlava, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2030007

Ostrava, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2030008

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2030009

Teplice, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2030001

Zlín, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500011

Bron, , France

Site Status RECRUITING

Investigational Site Number : 2500005

Créteil, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500017

Gonesse, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500006

La Tronche, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500009

Lille, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500015

Montpellier, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500016

Nancy, , France

Site Status RECRUITING

Investigational Site Number : 2500002

Nice, , France

Site Status RECRUITING

Investigational Site Number : 2500018

Orsay, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500007

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500014

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500003

Rennes, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500010

Saint-Herblain, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2500001

Strasbourg, , France

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 2760009

Bielefeld, , Germany

Site Status RECRUITING

Investigational Site Number : 2760010

Bochum, , Germany

Site Status RECRUITING

Investigational Site Number : 2760012

Dresden, , Germany

Site Status RECRUITING

Investigational Site Number : 2760002

Düsseldorf, , Germany

Site Status RECRUITING

Investigational Site Number : 2760013

Erbach im Odenwald, , Germany

Site Status RECRUITING

Investigational Site Number : 2760014

Heidelberg, , Germany

Site Status RECRUITING

Investigational Site Number : 2760007

Jena, , Germany

Site Status RECRUITING

Investigational Site Number : 2760003

Leipzig, , Germany

Site Status RECRUITING

Investigational Site Number : 2760008

Marburg, , Germany

Site Status RECRUITING

Investigational Site Number : 2760006

Münster, , Germany

Site Status RECRUITING

Investigational Site Number : 2760001

Ulm, , Germany

Site Status RECRUITING

Investigational Site Number : 3000003

Athens, , Greece

Site Status RECRUITING

Investigational Site Number : 3000005

Athens, , Greece

Site Status RECRUITING

Investigational Site Number : 3000004

Ioannina, , Greece

Site Status RECRUITING

Investigational Site Number : 3000001

Larissa, , Greece

Site Status RECRUITING

Investigational Site Number : 3000002

Thessaloniki, , Greece

Site Status RECRUITING

Investigational Site Number : 3480003

Budapest, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3480004

Budapest, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3480006

Budapest, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3480002

Győr, , Hungary

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3560024

Bengaluru, , India

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3560008

Hyderabad, , India

Site Status COMPLETED

Investigational Site Number : 3560017

New Delhi, , India

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3560006

Shimla, , India

Site Status COMPLETED

Investigational Site Number : 3800034

Augusta, Catania, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800025

Cona, Ferrara, Italy

Site Status RECRUITING

Investigational Site Number : 3800004

Florence, Firenze, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800011

Genoa, Genova, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800008

Pozzilli, Isernia, Italy

Site Status COMPLETED

Investigational Site Number : 3800002

Milan, Milano, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800016

Milan, Milano, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800010

Naples, Napoli, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800006

Cefalù, Palermo, Italy

Site Status RECRUITING

Investigational Site Number : 3800015

Rome, Roma, Italy

Site Status RECRUITING

Investigational Site Number : 3800001

Rome, Roma, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800013

Rome, Roma, Italy

Site Status RECRUITING

Investigational Site Number : 3800021

Rome, Roma, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800035

Gallarate, Varese, Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800009

Bologna, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800014

Chieti, , Italy

Site Status RECRUITING

Investigational Site Number : 3800019

Foggia, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800026

Novara, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800017

Palermo, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800029

Parma, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800005

Pavia, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800003

Perugia, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3800030

Ravenna, , Italy

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 3920003

Kōriyama, Fukushima, Japan

Site Status RECRUITING

Investigational Site Number : 3920014

Asahikawa, Hokkaido, Japan

Site Status RECRUITING

Investigational Site Number : 3920007

Himeji, Hyōgo, Japan

Site Status RECRUITING

Investigational Site Number : 3920010

Sagamihara, Kanagawa, Japan

Site Status RECRUITING

Investigational Site Number : 3920015

Higashi-Matsuyama, Saitama, Japan

Site Status RECRUITING

Investigational Site Number : 3920016

Kodaira, Tokyo, Japan

Site Status RECRUITING

Investigational Site Number : 3920002

Chiba, , Japan

Site Status RECRUITING

Investigational Site Number : 3920013

Fukuoka, , Japan

Site Status RECRUITING

Investigational Site Number : 3920001

Kyoto, , Japan

Site Status RECRUITING

Investigational Site Number : 3920011

Tokyo, , Japan

Site Status RECRUITING

Investigational Site Number : 3920012

Tokyo, , Japan

Site Status RECRUITING

Investigational Site Number : 5280002

Rotterdam, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160002

Plewiska, Greater Poland Voivodeship, Poland

Site Status RECRUITING

Investigational Site Number : 6160012

Poznan, Greater Poland Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160018

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160005

Krakow, Lesser Poland Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160006

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160007

Bialystok, Podlaskie Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160010

Katowice, Silesian Voivodeship, Poland

Site Status COMPLETED

Investigational Site Number : 6160011

Katowice, Silesian Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160004

Zabrze, Silesian Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6200001

Braga, , Portugal

Site Status RECRUITING

Investigational Site Number : 6200011

Lisbon, , Portugal

Site Status RECRUITING

Investigational Site Number : 6200007

Lisbon, , Portugal

Site Status RECRUITING

Investigational Site Number : 6200006

Lisbon, , Portugal

Site Status RECRUITING

Investigational Site Number : 6200002

Matosinhos Municipality, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 6820001

Riyadh, , Saudi Arabia

Site Status RECRUITING

Investigational Site Number : 4100001

Goyang-si, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100007

Seongnam-si, Gyeonggi-do, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, South Korea

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea

Site Status COMPLETED

Investigational Site Number : 7240018

Murcia, Almería, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240016

Barcelona, Barcelona [Barcelona], Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240010

Barcelona, Barcelona [Barcelona], Spain

Site Status RECRUITING

Investigational Site Number : 7240009

Barakaldo, Basque Country, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240011

L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240012

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240024

Girona, Girona [Gerona], Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240013

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240015

Lleida, Lleida [Lérida], Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240017

Majadahonda, Madrid, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240001

Pozuelo de Alarcón, Madrid, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240014

Pontevedra, Pontevedra [Pontevedra], Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240007

Seville, Sevilla, Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240004

Córdoba, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240006

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240023

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240002

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240003

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240022

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240005

Málaga, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240008

Valencia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7240025

Zaragoza, , Spain

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7520001

Gothenburg, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7520005

Huddinge, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7520003

Malmo, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7520002

Stockholm, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920018

Ankara, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920011

Ankara, , Turkey (Türkiye)

Site Status COMPLETED

Investigational Site Number : 7920020

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Investigational Site Number : 7920013

Bursa, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920005

Eskişehir, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920012

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920002

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920016

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920009

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Investigational Site Number : 7920007

Istanbul, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920019

Izmir, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920008

Izmir, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920001

İzmit, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920014

Kayseri, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920015

Konya, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 7920006

Mersin, , Turkey (Türkiye)

Site Status COMPLETED

Investigational Site Number : 7920004

Samsun, , Turkey (Türkiye)

Site Status COMPLETED

Investigational Site Number : 7920003

Sultangazi, , Turkey (Türkiye)

Site Status COMPLETED

Investigational Site Number : 7920017

Van, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040001

Chernivtsi, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040009

Ivano-Frankivsk, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040003

Ivano-Frankivsk, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040006

Kyiv, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040008

Lutsk, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040004

Lviv, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040002

Lviv, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8040005

Vinnytsia, , Ukraine

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260011

Gwent, Blaenau Gwent, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260001

Exeter, Devon, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260013

London, England, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260006

Newcastle upon Tyne, England, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8260010

Inverness, Highland, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8260003

Canterbury, Kent, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8260008

Salford, Manchester, United Kingdom

Site Status RECRUITING

Investigational Site Number : 8260004

Oxford, Oxfordshire, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260005

Swansea, Swansea [Abertawe Gb-ata], United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260007

Cardiff, Vale of Glamorgan, the, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 8260009

Liverpool, , United Kingdom

Site Status RECRUITING

Countries

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

United States Argentina Australia Belgium Brazil Bulgaria Canada Chile China Czechia France Germany Greece Hungary India Italy Japan Netherlands Poland Portugal Saudi Arabia South Korea Spain Sweden Turkey (Türkiye) Ukraine United Kingdom

Central Contacts

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

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

Role: CONTACT

800-633-1610 ext. option 6

Related Links

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

Other Identifiers

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U1111-1280-7114

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-504359-29

Identifier Type: REGISTRY

Identifier Source: secondary_id

EFC17504

Identifier Type: -

Identifier Source: org_study_id

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