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Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
NCT06141486 · Sanofi
In plain English
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Official title
A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 900 participants
Allocation: randomized
Masking: quadruple
Age groups: adult
Timeline
Starts: 2023-12-27
Estimated completion: 2028-03-24
Last updated: 2026-02-23
Interventions
Drug: FrexalimabDrug: PlaceboDrug: MRI contrast-enhancing agents
Primary outcomes
- • Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period (Up to 36 months)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free number for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (338)
Alabama Neurology Associates- Site Number : 8400115Recruiting
Birmingham, Alabama, United States
Dignity Health St. Joseph's Hospital and Medical Center- Site Number : 8400139Recruiting
Phoenix, Arizona, United States
HonorHealth Neurology- Site Number : 8400074Recruiting
Scottsdale, Arizona, United States
Perseverance Research Center- Site Number : 8400138Recruiting
Scottsdale, Arizona, United States
Imaging EndPoints- Site Number : 8400050Recruiting
Scottsdale, Arizona, United States
Sutter East Bay Medical Foundation- Site Number : 8400134Recruiting
Berkeley, California, United States
The Research Center of Southern California, LLC- Site Number : 8400023Recruiting
Carlsbad, California, United States
University of California, Irvine- Site Number : 8400143Recruiting
Irvine, California, United States
University of California San Diego- Site Number : 8400095Recruiting
La Jolla, California, United States
Southern California Permanente Medical Group- Site Number : 8400184Recruiting
Los Angeles, California, United States
University of Southern California, Los Angeles- Site Number : 8400118Recruiting
Los Angeles, California, United States
Hoag Memorial Hospital- Site Number : 8400031Recruiting
Newport Beach, California, United States
Stanford Neuroscience Health Center- Site Number : 8400120Recruiting
Palo Alto, California, United States
Regina Berkovich, MD, PhD- Site Number : 8400005Recruiting
West Hollywood, California, United States
University of Colorado Health Science Center- Site Number : 8400001Recruiting
Aurora, Colorado, United States
Advanced Neurosciences Research- Site Number : 8400148Recruiting
Fort Collins, Colorado, United States
Yale University- Site Number : 8400081Recruiting
New Haven, Connecticut, United States
Hartford Healthcare Medical Group- Site Number : 8400069Recruiting
Norwich, Connecticut, United States
New England Institute for Clinical Research- Site Number : 8400114Recruiting
Stamford, Connecticut, United States
Georgetown University Hospital- Site Number : 8400044Recruiting
Washington D.C., District of Columbia, United States
Neurology of Central Florida Research Center, LLC- Site Number : 8400147Recruiting
Altamonte Springs, Florida, United States
First Choice Neurology- Site Number : 8400169Recruiting
Boca Raton, Florida, United States
MS & Neuromuscular Center of Excellence- Site Number : 8400015Recruiting
Clearwater, Florida, United States
Beth Israel Deaconess Medical Center- Site Number : 8400041Recruiting
Fort Myers, Florida, United States
University of Florida Health- Site Number : 8400054Recruiting
Gainesville, Florida, United States
Mayo Clinic- Site Number : 8400093Recruiting
Jacksonville, Florida, United States
Neurology Associates, PA- Site Number : 8400010Recruiting
Maitland, Florida, United States
University of Miami- Site Number : 8400177Recruiting
Miami, Florida, United States
Orlando Health Neuroscience Institute- Site Number : 8400060Recruiting
Orlando, Florida, United States
Axiom Clinical Research of Florida- Site Number : 8400049Recruiting
Tampa, Florida, United States
University of South Florida- Site Number : 8400013Recruiting
Tampa, Florida, United States
Premiere Research Institute at Palm Beach Neurology- Site Number : 8400105Recruiting
West Palm Beach, Florida, United States
Savannah Neurology Specialists- Site Number : 8400061Recruiting
Savannah, Georgia, United States
Joi Life Wellness Group LLC- Site Number : 8400192Recruiting
Smyrna, Georgia, United States
Rush University Medical Center- Site Number : 8400102Recruiting
Chicago, Illinois, United States
University of Chicago Biological Science/Neurology (The) University of Chicago Medical Center)- Site Number : 8400055Recruiting
Chicago, Illinois, United States
Consultants In Neurology- Site Number : 8400020Recruiting
Northbrook, Illinois, United States
Springfield Clinic, LLP- Site Number : 8400043Recruiting
Springfield, Illinois, United States
Neuroscience Institute Center- Site Number : 8400053Recruiting
Merrillville, Indiana, United States
University Of Iowa Hospitals And Clinics- Site Number : 8400029Recruiting
Iowa City, Iowa, United States
University of Kansas Medical Center- Site Number : 8400084Recruiting
Kansas City, Kansas, United States
College Park Family Care Center- Site Number : 8400032Recruiting
Overland Park, Kansas, United States
Baptist Health Lexington- Site Number : 8400149Recruiting
Lexington, Kentucky, United States
Neuromedical Clinic of CENLA, LLC- Site Number : 8400159Recruiting
Alexandria, Louisiana, United States
DelRicht Research- Site Number : 8400182Recruiting
Baton Rouge, Louisiana, United States
Ochsner Clinic Foundation- Site Number : 8400027Recruiting
New Orleans, Louisiana, United States
University of Maryland, Baltimore- Site Number : 8400185Recruiting
Baltimore, Maryland, United States
Johns Hopkins University- Site Number : 8400080Recruiting
Baltimore, Maryland, United States
International Neurorehabilitation Institute- Site Number : 8400089Recruiting
Lutherville, Maryland, United States
Tufts Medical Center- Site Number : 8400003Recruiting
Boston, Massachusetts, United States
Boston Clinical Trials- Site Number : 8400178Recruiting
Boston, Massachusetts, United States
Neurology Center of New England PC- Site Number : 8400164Recruiting
Foxborough, Massachusetts, United States
The Elliot Lewis Center for Multiple Sclerosis Care- Site Number : 8400033Recruiting
Wellesley, Massachusetts, United States
University of Massachusetts- Site Number : 8400028Recruiting
Worcester, Massachusetts, United States
~Henry Ford Hospital- Site Number : 8400091Active Not Recruiting
Detroit, Michigan, United States
Michigan Institute For Neurological Disorders- Site Number : 8400004Recruiting
Farmington Hills, Michigan, United States
Trinity Health Grand Rapids- Site Number : 8400150Recruiting
Grand Rapids, Michigan, United States
Memorial Healthcare Institute for Neuroscience- Site Number : 8400123Recruiting
Owosso, Michigan, United States
Profound Research / Rochester Medical Group / Michigan Health Partners- Site Number : 8400172Recruiting
Rochester Hills, Michigan, United States
Minneapolis Clinic of Neurology- Site Number : 8400077Recruiting
Minneapolis, Minnesota, United States
University of Minnesota - Department of Neurology- Site Number : 8400056Recruiting
Minneapolis, Minnesota, United States
Minnesota Center for Multiple Sclerosis- Site Number : 8400073Recruiting
Plymouth, Minnesota, United States
Sharlin Health & Neurology- Site Number : 8400016Recruiting
Ozark, Missouri, United States
Washington University School of Medicine- Site Number : 8400076Recruiting
St Louis, Missouri, United States
Lou Ruvo Center for Brain Health- Site Number : 8400045Recruiting
Las Vegas, Nevada, United States
Renown Institute for Neurosciences- Site Number : 8400066Recruiting
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center- Site Number : 8400098Recruiting
Lebanon, New Hampshire, United States
Rutgers University - Robert Wood Johnson Medical School- Site Number : 8400067Recruiting
New Brunswick, New Jersey, United States
Holy Name Medical Center- Site Number : 8400101Recruiting
Teaneck, New Jersey, United States
University of New Mexico- Site Number : 8400090Recruiting
Albuquerque, New Mexico, United States
Dent Neurologic Institute- Site Number : 8400129Recruiting
Amherst, New York, United States
Icahn School of Medicine at Mount Sinai.- Site Number : 8400011Recruiting
New York, New York, United States
Columbia University Medical Center- Site Number : 8400088Recruiting
New York, New York, United States
Neurology Associates of Stony Brook- Site Number : 8400094Recruiting
Stony Brook, New York, United States
Piedmont Healthcare/Research- Site Number : 8400002Recruiting
Charlotte, North Carolina, United States
Velocity Clinical Research, Inc- Site Number : 8400014Recruiting
Raleigh, North Carolina, United States
Atrium Health Wake Forest Baptist- Site Number : 8400040Recruiting
Winston-Salem, North Carolina, United States
Sanford Brain and Spine Center- Site Number : 8400085Recruiting
Fargo, North Dakota, United States
Riverhills Neuroscience - Norwood- Site Number : 8400007Recruiting
Cincinnati, Ohio, United States
University of Cincinnati Medical Center- Site Number : 8400117Recruiting
Cincinnati, Ohio, United States
Ohio State University- Site Number : 8400009Recruiting
Columbus, Ohio, United States
The Boster Center for Multiple Sclerosis- Site Number : 8400006Recruiting
Columbus, Ohio, United States
University of Cincinnati- Site Number : 8400008Recruiting
Dayton, Ohio, United States
Oklahoma Medical Research Foundation- Site Number : 8400039Recruiting
Oklahoma City, Oklahoma, United States
Providence Multiple Sclerosis Center- Site Number : 8400052Recruiting
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center- Site Number : 8400176Recruiting
Hershey, Pennsylvania, United States
Comprehensive MS Center Thomas Jefferson University Hospital- Site Number : 8400035Recruiting
Philadelphia, Pennsylvania, United States
Premier Neurology- Site Number : 8400047Recruiting
Greenville, South Carolina, United States
HOPE Neurology- Site Number : 8400019Recruiting
Knoxville, Tennessee, United States
Vanderbilt University Medical Center Vanderbilt Comprehensive Multiple Sclerosis Center- Site Number : 8400130Recruiting
Nashville, Tennessee, United States
Neurology Consultants of Dallas- Site Number : 8400152Recruiting
Dallas, Texas, United States
North Texas Institute of Neurology - Plano- Site Number : 8400083Recruiting
Plano, Texas, United States
Lone Star Neurology of San Antonio- Site Number : 8400099Recruiting
San Antonio, Texas, United States
Texas Institute for Neurological Disorders-Sherman- Site Number : 8400018Recruiting
Sherman, Texas, United States
University Of Vermont- Site Number : 8400042Recruiting
Burlington, Vermont, United States
INOVA Neurology- Site Number : 8400109Recruiting
Fairfax, Virginia, United States
Riverside Hampton Roads Neurology- Site Number : 8400132Recruiting
Newport News, Virginia, United States
MS Center of Greater Washington- Site Number : 8400128Recruiting
Vienna, Virginia, United States
Sentara Neurological Associates- Site Number : 8400168Recruiting
Virginia Beach, Virginia, United States
Swedish Medical Center- Site Number : 8400078Recruiting
Seattle, Washington, United States
West Virginia University- Site Number : 8400131Recruiting
Morgantown, West Virginia, United States
Wheaton Franciscan Healthcare- Site Number : 8400034Recruiting
Milwaukee, Wisconsin, United States
Medical College of Wisconsin- Site Number : 8400038Recruiting
Milwaukee, Wisconsin, United States
Investigational Site Number : 0320002Active Not Recruiting
CABA, Buenos Aires, Argentina
Investigational Site Number : 0321010Active Not Recruiting
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320007Active Not Recruiting
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320001Active Not Recruiting
CABA, Buenos Aires F.D., Argentina
Investigational Site Number : 0320003Active Not Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0360005Active Not Recruiting
St Leonards, New South Wales, Australia
Investigational Site Number : 0360001Active Not Recruiting
Woolloongabba, Queensland, Australia
Investigational Site Number : 0360002Active Not Recruiting
Heidelberg, Victoria, Australia
Investigational Site Number : 0560001Active Not Recruiting
Bruges, Belgium
Investigational Site Number : 0560006Active Not Recruiting
Ghent, Belgium
Investigational Site Number : 0560007Active Not Recruiting
Kortrijk, Belgium
Investigational Site Number : 0560003Active Not Recruiting
Melsbroek, Belgium
Investigational Site Number : 0560005Active Not Recruiting
Overpelt, Belgium
Investigational Site Number : 0560008Active Not Recruiting
Woluwe-Saint-Lambert, Belgium
CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES- Site Number : 0760029Active Not Recruiting
Vitória, Espírito Santo, Brazil
Instituto Bahiano de Imunoterapia - IBIS- Site Number : 0760030Active Not Recruiting
Salvador, Estado de Bahia, Brazil
L2IP Instituto de Pesquisas Clinicas- Site Number : 0760003Active Not Recruiting
Brasília, Federal District, Brazil
HC UFG - Hospital Das Clinicas de Goias- Site Number : 0760024Active Not Recruiting
Goiânia, Goiás, Brazil
Freire Pesquisa Clínica- Site Number : 0760025Active Not Recruiting
Belo Horizonte, Minas Gerais, Brazil
Instituto de Neurologia de Curitiba- Site Number : 0760001Active Not Recruiting
Curitiba, Paraná, Brazil
Hospital Moinhos de Vento - HMV - Site Number : 0760005Active Not Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Neurológica- Site Number : 0760031Active Not Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Ceos- Site Number : 0760028Active Not Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Neurologica e Neurocirurgica de Joinville - NEUROLOGICA- Site Number : 0760007Active Not Recruiting
Joinville, Santa Catarina, Brazil
Prognosis Pesquisa Clinica- Site Number : 0760032Active Not Recruiting
Santo André, São Paulo, Brazil
CPQuali Pesquisa Clinica- Site Number : 0760002Active Not Recruiting
São Paulo, São Paulo, Brazil
PSEG Centro de Pesquisa Clinica- Site Number : 0760021Active Not Recruiting
São Paulo, São Paulo, Brazil
Centro Medico Sinapse- Site Number : 0760004Active Not Recruiting
São Paulo, São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira - Hospital Israelita Albert Einstein- Site Number : 0760026Active Not Recruiting
São Paulo, São Paulo, Brazil
Investigational Site Number : 1000009Recruiting
Blagoevgrad, Bulgaria
Investigational Site Number : 1000008Recruiting
Panagyurishte, Bulgaria
Investigational Site Number : 1000007Recruiting
Pazardzhik, Bulgaria
Investigational Site Number : 1000010Recruiting
Pleven, Bulgaria
Investigational Site Number : 1000002Recruiting
Pleven, Bulgaria
Investigational Site Number : 1000004Recruiting
Sofia, Bulgaria
Investigational Site Number : 1000001Recruiting
Sofia, Bulgaria
Investigational Site Number : 1000006Recruiting
Sofia, Bulgaria
Investigational Site Number : 1000005Recruiting
Sofia, Bulgaria
Investigational Site Number : 1240011Recruiting
Calgary, Alberta, Canada
Investigational Site Number : 1240005Recruiting
Burnaby, British Columbia, Canada
Investigational Site Number : 1240010Recruiting
Vancouver, British Columbia, Canada
Investigational Site Number: 1240018Recruiting
Moncton, New Brunswick, Canada
Investigational Site Number : 1240014Recruiting
London, Ontario, Canada
Investigational Site Number : 1240015Recruiting
North York, Ontario, Canada
Investigational Site Number : 1240002Recruiting
Ottawa, Ontario, Canada
Investigational Site Number : 1240012Recruiting
Toronto, Ontario, Canada
Investigational Site Number : 1240001Recruiting
Gatineau, Quebec, Canada
Investigational Site Number : 1240008Recruiting
Lévis, Quebec, Canada
Investigational Site Number : 1240009Recruiting
Montreal, Quebec, Canada
Investigational Site Number : 1240016Recruiting
Montreal, Quebec, Canada
Investigational Site Number : 1240006Recruiting
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240003Recruiting
Québec, Canada
Investigational Site Number : 1520002Active Not Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001Active Not Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560005Completed
Beijing, China
Investigational Site Number : 1560008Completed
Beijing, China
Investigational Site Number : 1560007Active Not Recruiting
Beijing, China
Investigational Site Number : 1560003Active Not Recruiting
Changchun, China
Investigational Site Number : 1560011Active Not Recruiting
Changsha, China
Investigational Site Number : 1560004Active Not Recruiting
Chengdu, China
Investigational Site Number : 1560045Active Not Recruiting
Fuzhou, China
Investigational Site Number : 1560002Completed
Guangzhou, China
Investigational Site Number : 1561027Active Not Recruiting
Harbin, China
Investigational Site Number : 1560001Recruiting
Shanghai, China
Investigational Site Number : 1560010Recruiting
Shijiazhuang, China
Investigational Site Number : 1560006Active Not Recruiting
Taiyuan, China
Investigational Site Number : 1560012Recruiting
Tianjin, China
Investigational Site Number : 1560009Active Not Recruiting
Wuhan, China
Investigational Site Number : 1560013Recruiting
Xi'an, China
Investigational Site Number : 1560034Recruiting
Zhengzhou, China
Investigational Site Number : 2030011Active Not Recruiting
Brno, Czechia
Investigational Site Number : 2030005Active Not Recruiting
Brno, Czechia
Investigational Site Number : 2030002Active Not Recruiting
Hradec Králové, Czechia
Investigational Site Number : 2030006Active Not Recruiting
Jihlava, Czechia
Investigational Site Number : 2030007Active Not Recruiting
Ostrava - Poruba, Czechia
Investigational Site Number : 2030008Active Not Recruiting
Praha 5 - Motol, Czechia
Investigational Site Number : 2030009Active Not Recruiting
Teplice, Czechia
Investigational Site Number : 2030001Active Not Recruiting
Zlín, Czechia
Investigational Site Number : 2500011Recruiting
Bron, France
Investigational Site Number : 2500005Active Not Recruiting
Créteil, France
Investigational Site Number : 2500017Active Not Recruiting
Gonesse, France
Investigational Site Number : 2500006Active Not Recruiting
Grenoble, France
Investigational Site Number : 2500009Active Not Recruiting
Lille, France
Investigational Site Number : 2500015Active Not Recruiting
Montpellier, France
Investigational Site Number : 2500016Active Not Recruiting
Nancy, France
Investigational Site Number : 2500002Recruiting
Nice, France
Investigational Site Number : 2500018Active Not Recruiting
Orsay, France
Investigational Site Number : 2500014Active Not Recruiting
Paris, France
Investigational Site Number : 2500007Active Not Recruiting
Paris, France
Investigational Site Number : 2500003Active Not Recruiting
Rennes, France
Investigational Site Number : 2500010Active Not Recruiting
Saint-Herblain, France
Investigational Site Number : 2500001Active Not Recruiting
Strasbourg, France
Investigational Site Number : 2760014Recruiting
Berlin, Germany
Investigational Site Number : 2760009Recruiting
Bielefeld, Germany
Investigational Site Number : 2760010Recruiting
Bochum, Germany
Investigational Site Number : 2760012Recruiting
Dresden, Germany
Investigational Site Number : 2760002Recruiting
Düsseldorf, Germany
Investigational Site Number : 2760013Recruiting
Erbach im Odenwald, Germany
Investigational Site Number : 2760007Recruiting
Jena, Germany
Investigational Site Number : 2760003Recruiting
Leipzig, Germany
Investigational Site Number : 2760008Recruiting
Marburg, Germany
Investigational Site Number : 2760006Recruiting
Münster, Germany
Investigational Site Number : 2760001Recruiting
Ulm, Germany
Investigational Site Number : 3000003Active Not Recruiting
Athens, Greece
Investigational Site Number : 3000005Active Not Recruiting
Athens, Greece
Investigational Site Number : 3000004Active Not Recruiting
Ioannina, Greece
Investigational Site Number : 3000001Active Not Recruiting
Larissa, Greece
Investigational Site Number : 3000002Active Not Recruiting
Thessaloniki, Greece
Investigational Site Number : 3480003Active Not Recruiting
Budapest, Hungary
Investigational Site Number : 3480004Active Not Recruiting
Budapest, Hungary
Investigational Site Number : 3480006Active Not Recruiting
Budapest, Hungary
Investigational Site Number : 3480002Active Not Recruiting
Győr, Hungary
Investigational Site Number : 3560024Active Not Recruiting
Bengaluru, India
Investigational Site Number : 3560017Active Not Recruiting
Delhi, India
Investigational Site Number : 3560008Completed
Punjagutta, India
Investigational Site Number : 3560006Completed
Shimla, India
Investigational Site Number : 3800025Recruiting
Cona (Ferrara), Ferrara, Italy
Investigational Site Number : 3800008Completed
Pozzilli, Isernia, Italy
Investigational Site Number : 3800016Active Not Recruiting
Milan, Lombardy, Italy
Investigational Site Number : 3800006Active Not Recruiting
Cefalù, Palermo, Italy
Investigational Site Number : 3800015Recruiting
Rome, Roma, Italy
Investigational Site Number : 3800034Active Not Recruiting
Augusta, Salerno, Italy
Investigational Site Number : 3800035Active Not Recruiting
Gallarate, Varese, Italy
Investigational Site Number : 3800009Active Not Recruiting
Bologna, Italy
Investigational Site Number : 3800014Recruiting
Chieti, Italy
Investigational Site Number : 3800004Active Not Recruiting
Florence, Italy
Investigational Site Number : 3800019Active Not Recruiting
Foggia, Italy
Investigational Site Number : 3800011Active Not Recruiting
Genova, Italy
Investigational Site Number : 3800002Active Not Recruiting
Milan, Italy
Investigational Site Number : 3800010Active Not Recruiting
Naples, Italy
Investigational Site Number : 3800026Active Not Recruiting
Novara, Italy
Investigational Site Number : 3800017Active Not Recruiting
Palermo, Italy
Investigational Site Number : 3800029Active Not Recruiting
Parma, Italy
Investigational Site Number : 3800005Active Not Recruiting
Pavia, Italy
Investigational Site Number : 3800003Active Not Recruiting
Perugia, Italy
Investigational Site Number : 3800030Active Not Recruiting
Ravenna, Italy
Investigational Site Number : 3800001Active Not Recruiting
Roma, Italy
Investigational Site Number : 3800013Active Not Recruiting
Roma, Italy
Investigational Site Number : 3800021Active Not Recruiting
Roma, Italy
Investigational Site Number : 3920002Recruiting
Chiba, Chiba, Japan
Investigational Site Number : 3920013Recruiting
Fukuoka, Fukuoka, Japan
Investigational Site Number : 3920003Recruiting
Koriyama-shi, Fukushima, Japan
Investigational Site Number : 3920014Recruiting
Asahikawa-shi, Hokkaido, Japan
Investigational Site Number : 3920007Recruiting
Himeji, Hyōgo, Japan
Investigational Site Number : 3920010Recruiting
Sagamihara-shi, Kanagawa, Japan
Investigational Site Number : 3920001Recruiting
Kyoto, Kyoto, Japan
Investigational Site Number : 3920015Recruiting
Higashimatsuyama-shi, Saitama, Japan
Investigational Site Number : 3920016Recruiting
Kodaira-shi, Tokyo, Japan
Investigational Site Number : 3920011Recruiting
Ōta-ku, Tokyo, Japan
Investigational Site Number : 3920012Recruiting
Shinjuku-ku, Tokyo, Japan
Investigational Site Number : 5280002Active Not Recruiting
Rotterdam, Netherlands
Investigational Site Number : 6160002Recruiting
Plewiska, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160012Active Not Recruiting
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160018Active Not Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160005Active Not Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160007Active Not Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160010Completed
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160011Active Not Recruiting
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160004Active Not Recruiting
Zabrze, Silesian Voivodeship, Poland
Investigational Site Number : 6160006Active Not Recruiting
Rzeszów, Poland
Investigational Site Number : 6200001Active Not Recruiting
Braga, Portugal
Investigational Site Number : 6200011Recruiting
Lisbon, Portugal
Investigational Site Number : 6200007Recruiting
Lisbon, Portugal
Investigational Site Number : 6200006Recruiting
Lisbon, Portugal
Investigational Site Number : 6200002Active Not Recruiting
Matosinhos Municipality, Portugal
Investigational Site Number : 6820001Recruiting
Riyadh, Saudi Arabia
Investigational Site Number : 4100001Active Not Recruiting
Goyang-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100007Active Not Recruiting
Seongnam-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100002Active Not Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004Active Not Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003Completed
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240007Active Not Recruiting
Seville, Andalusia, Spain
Investigational Site Number : 7240016Active Not Recruiting
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240010Active Not Recruiting
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240011Active Not Recruiting
L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009Active Not Recruiting
Barakaldo, Bizkaia, Spain
Investigational Site Number : 7240012Active Not Recruiting
Donostia / San Sebastian, Gipuzkoa, Spain
Investigational Site Number : 7240024Active Not Recruiting
Salt, Girona [Gerona], Spain
Investigational Site Number : 7240013Active Not Recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 7240015Active Not Recruiting
Lleida / Lleida, Lleida [Lérida], Spain
Investigational Site Number : 7240017Active Not Recruiting
Majadahonda, Madrid, Spain
Investigational Site Number : 7240001Active Not Recruiting
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240023Active Not Recruiting
Madrid / Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240022Active Not Recruiting
Madrid / Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240004Active Not Recruiting
Córdoba, Spain
Investigational Site Number : 7240006Active Not Recruiting
Madrid, Spain
Investigational Site Number : 7240002Active Not Recruiting
Madrid, Spain
Investigational Site Number : 7240003Active Not Recruiting
Madrid, Spain
Investigational Site Number : 7240005Active Not Recruiting
Málaga, Spain
Investigational Site Number : 7240018Active Not Recruiting
Murcia, Spain
Investigational Site Number : 7240008Active Not Recruiting
Valencia, Spain
Investigational Site Number : 7240014Active Not Recruiting
Vigo, Spain
Investigational Site Number : 7240025Active Not Recruiting
Zaragoza, Spain
Investigational Site Number : 7520001Active Not Recruiting
Gothenburg, Sweden
Investigational Site Number : 7520003Active Not Recruiting
Malmo, Sweden
Investigational Site Number : 7520002Active Not Recruiting
Stockholm, Sweden
Investigational Site Number : 7520005Active Not Recruiting
Stockholm, Sweden
Investigational Site Number : 7920018Active Not Recruiting
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920011Completed
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920020Recruiting
Bursa, Turkey (Türkiye)
Investigational Site Number : 7920013Active Not Recruiting
Bursa, Turkey (Türkiye)
Investigational Site Number : 7920005Active Not Recruiting
Eskişehir, Turkey (Türkiye)
Investigational Site Number : 7920012Active Not Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920016Active Not Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920003Completed
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920002Active Not Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920009Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920007Active Not Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920019Active Not Recruiting
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920008Active Not Recruiting
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920014Active Not Recruiting
Kayseri, Turkey (Türkiye)
Investigational Site Number : 7920001Active Not Recruiting
Kocaeli, Turkey (Türkiye)
Investigational Site Number : 7920015Active Not Recruiting
Konya, Turkey (Türkiye)
Investigational Site Number : 7920006Completed
Mersin, Turkey (Türkiye)
Investigational Site Number : 7920004Completed
Samsun, Turkey (Türkiye)
Investigational Site Number : 7920017Active Not Recruiting
Van, Turkey (Türkiye)
Investigational Site Number : 8040001Active Not Recruiting
Chernivtsi, Ukraine
Investigational Site Number : 8040009Active Not Recruiting
Ivano-Frankivsk, Ukraine
Investigational Site Number : 8040003Active Not Recruiting
Ivano-Frankivsk, Ukraine
Investigational Site Number : 8040006Active Not Recruiting
Kyiv, Ukraine
Investigational Site Number : 8040008Active Not Recruiting
Lutsk, Ukraine
Investigational Site Number : 8040004Active Not Recruiting
Lviv, Ukraine
Investigational Site Number : 8040002Active Not Recruiting
Lviv, Ukraine
Investigational Site Number : 8040005Active Not Recruiting
Vinnytsia, Ukraine
Investigational Site Number : 8260001Active Not Recruiting
Exeter, Devon, United Kingdom
Investigational Site Number : 8260003Active Not Recruiting
Kent, Kent, United Kingdom
Investigational Site Number : 8260009Active Not Recruiting
Fazakerley, Liverpool, United Kingdom
Investigational Site Number : 8260013Active Not Recruiting
London, London, City of, United Kingdom
Investigational Site Number : 8260005Active Not Recruiting
Swansea, Neath Port Talbot, United Kingdom
Investigational Site Number : 8260004Active Not Recruiting
Oxford, Oxfordshire, United Kingdom
Investigational Site Number : 8260007Active Not Recruiting
Cardiff, Vale of Glamorgan, the, United Kingdom
Investigational Site Number : 8260010Completed
Inverness, United Kingdom
Investigational Site Number : 8260006Active Not Recruiting
Newcastle upon Tyne, United Kingdom
Investigational Site Number : 8260011Active Not Recruiting
Newport, United Kingdom
Investigational Site Number : 8260008Active Not Recruiting
Salford, United Kingdom