A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
NCT ID: NCT06455202
Last Updated: 2025-12-18
Study Results
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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RECRUITING
PHASE3
915 participants
INTERVENTIONAL
2024-07-19
2027-04-30
Brief Summary
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Detailed Description
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There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.
Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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barzolvolimab 150 mg
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
barzolvolimab
Subcutaneous Administration
barzolvolimab 300 mg
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
barzolvolimab
Subcutaneous Administration
Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
barzolvolimab
Subcutaneous Administration
Matching placebo
Matching placebo Subcutaneous Administration
Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
barzolvolimab
Subcutaneous Administration
Matching placebo
Matching placebo Subcutaneous Administration
Interventions
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barzolvolimab
Subcutaneous Administration
Matching placebo
Matching placebo Subcutaneous Administration
Eligibility Criteria
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Inclusion Criteria
2. Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
7. Participants with and without prior biologic experience are eligible.
Exclusion Criteria
2. Chronic urticaria whose predominant manifestation is due to CIndU.
3. Other diseases associated with urticaria.
4. Active pruritic skin condition in addition to CSU.
5. Medical condition that would cause additional risk or interfere with study procedures.
6. Known HIV, hepatitis B or hepatitis C infection.
7. Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
8. History of anaphylaxis
9. Prior treatment with barzolvolimab
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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Allervie Clinical Research - Cullman
Cullman, Alabama, United States
Research Solutions of Arizona PC
Litchfield Park, Arizona, United States
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
Scottsdale, Arizona, United States
Center for Dermatology & Plastic Surgery
Scottsdale, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Kern Research, Inc.
Bakersfield, California, United States
UCLA Clinical Trials Contracts & Strategic Relations
Los Angeles, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
LA Universal Research Center, Inc.
Los Angeles, California, United States
Allergy and Asthma Associates of Southern Cal
Mission Viejo, California, United States
Huntington Asthma & Allergy Center
Pasadena, California, United States
Apex Clinical Research
San Diego, California, United States
WR-MCCR
San Diego, California, United States
University Clinical Trials
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Clarity Dermatology, PLLC
Castle Rock, Colorado, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, United States
ClearlyDerm Boca Raton - ClinEdge - PPDS
Boca Raton, Florida, United States
Driven Research LLC
Coral Gables, Florida, United States
Palm Beach Dermatology Group
Delray Beach, Florida, United States
Dolphin Medical Research
Doral, Florida, United States
South FL Clinical Research LLC
Miami, Florida, United States
Dade Florida Clinical Research Center
Miami, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Revival Clinical Research
Orlando, Florida, United States
International Clinical Research - FL LLC
Sanford, Florida, United States
Allergy and Asthma Diagnostic treatment Center - CRN - PPDS
Tallahassee, Florida, United States
D&H Tamarac Research Center, LLC
Tamarac, Florida, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, United States
Deluxe Health Center
Tampa, Florida, United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Lane Dermatology Research - Centricity - PPDS
Columbus, Georgia, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Henry J. Kanarek - Allergy,Asthma&Immunology
Overland Park, Kansas, United States
Equity Medical
Bowling Green, Kentucky, United States
Allergy & Asthma Associates
Lexington, Kentucky, United States
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
Baton Rouge, Louisiana, United States
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
Towson, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Derm Institute of Western Michigan
Caledonia, Michigan, United States
Clarkston Skin Research - Clarkston
Clarkston, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
Midwest Clinical Research, LLC
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Skin Specialists PC
Omaha, Nebraska, United States
Hudson-Essex Allergy
Belleville, New Jersey, United States
Impact Medical / Circuit Clinical
Paramus, New Jersey, United States
Impact Medical / Circuit Clinical
Riverdale, New Jersey, United States
Equity Medical LLC
New York, New York, United States
OptiSkin Medical
New York, New York, United States
Optima Research
Boardman, Ohio, United States
Optimed Research Ltd - ClinEdge - PPDS
Columbus, Ohio, United States
Penn State Health Milton Hershey Med Cen
Hershey, Pennsylvania, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
University of Texas Health McGovern Medical
Bellaire, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Rainey & Finklea San Antonio Dermatology
San Antonio, Texas, United States
Allergy Associates of Utah - Sandy
Murray, Utah, United States
Jordan Valley Dermatology Center-South Jordan
South Jordan, Utah, United States
Kalo Clinical Research
West Valley City, Utah, United States
Virginia Dermatology and Skin Cancer Center - Norfolk
Norfolk, Virginia, United States
Novatrials
Charlestown, New South Wales, Australia
Skin and Cancer Foundation - The Skin Hospital
Darlinghurst, New South Wales, Australia
St George Dermatology and Skin Cancer Center
Kogarah, New South Wales, Australia
Momentum Clinical Research Darlinghurst
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Cornerstone Dermatology
Coorparoo, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Medical Centre Asklepii OOD
Dupnitsa, , Bulgaria
Medical Center - Pulmo 2018
Haskovo, , Bulgaria
Medical Center Medconsult Pleven
Lovech, , Bulgaria
Multiprofile Hospital for Active Treatment - Pazardzhik AD
Pazardzhik, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, , Bulgaria
Medical Center Prolet
Rousse, , Bulgaria
Medical Center Unimed EOOD
Sevlievo, , Bulgaria
Diagnostic-consultative center Ascendent EOOD
Sofia, , Bulgaria
Diagnostic and Consultative Center Aleksandrovska EOOD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"
Sofia, , Bulgaria
Diagnostic-Consultative Centre Convex EOOD
Sofia, , Bulgaria
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, Canada
Vida Clinical Research
Edmonton, Alberta, Canada
Rejuvenation Dermatology Edmonton South
Edmonton, Alberta, Canada
LEADER research
Hamilton, Ontario, Canada
DermEffects
London, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, Canada
North York Research Inc.
Toronto, Ontario, Canada
Joel Liem Medicine Professional Corporation
Windsor, Ontario, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, Canada
Kingston Health Science Center
Kingston, , Canada
Centre de Recherche Saint-Louis (Québec)
Québec, , Canada
Clinica MEDS La Dehesa
Lo Barnechea, , Chile
Hospital Base San Jose de Osorno
Osorno, , Chile
Enroll SpA - Dr. Manuel Barros Borgono
Providencia, , Chile
Clinica Davila - Recoleta
Recoleta, , Chile
Centro Internacional de Estudios Clinicos (CIEC)
Recoleta, , Chile
BIOCINETIC Ltda
Santiago, , Chile
Medical Skin Center
Viña del Mar, , Chile
Dermacross Clinica Dermatologica
Vitacura, , Chile
Centro Integral de Reumatologia Del Caribe
Barranquilla, , Colombia
Hospital Alma Mater de Antioquia
Medellín, , Colombia
Centro de Inmunología y Genética - CIGE S.A.S
Medellín, , Colombia
Hospital General de Medellín Luz Castro de Gutiérrez
Medellín, , Colombia
Fundación Centro de Investigation Clínica CIC
Medellín, , Colombia
Fundación Hospital Universidad del Norte
Soledad, , Colombia
Special Hospital Medico
Rijeka, , Croatia
Solmed Clinic
Zagreb, , Croatia
LTD" Healthy Future"
Tbilisi, , Georgia
LTD "Center of Allergy and Immunology"
Tbilisi, , Georgia
David Abuladze Georgian Italian Clinic
Tbilisi, , Georgia
LTD "Multiprofile Clinic Consilium Medulla"
Tbilisi, , Georgia
Universitätsklinikum der RWTH Aachen Hautklinik
Aachen, , Germany
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Emovis GmbH
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Essen
Essen, , Germany
Eurofins bioskin Research Center Dermalology
Hamburg, , Germany
UKSH Lübeck, Institut für Entzündungsmedizin
Lübeck, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Universitätsklinikum Münster
Münster, , Germany
Hautarztpraxis Dariusch Mortazawi
Remscheid, , Germany
Universitäts-Hautklinik, Studienzentrum Immundermatologie
Tübingen, , Germany
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, , Hungary
Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Allergo-Derm Bakos Kft.
Szolnok, , Hungary
Nirmal Hospital PVT LTD
Surat, Gujarat, India
Medical College Baroda & SSG Hospital
Vadodara, Gujarat, India
Shree Hospital & Critical Care Centre
Nagpur, Maharashtra, India
Assured Care Plus Hospital
Nashik, Maharashtra, India
Oyster & Pearl Hospitals
Pune, Maharashtra, India
Excelcare Hospital
Jaipur, Rajasthan, India
G.S.V.M. Medical College - Kanpur
Kanpur, Uttar Pradesh, India
Panchshil Hospital - Ahmedabad
Ahmedabad, , India
B. J. Medical College and Civil Hospital
Ahmedabad, , India
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Belagavi, , India
All India Institute of Medical Sciences
Bhubaneswar, , India
Apex Hospitals Pvt Ltd
Jaipur, , India
K R Hospital
Mysore, , India
Deenanath Mangeshkar Hospital and Research Centre
Pune, , India
Sumandeep Vidyapeeth University - Dhiraj Hospital
Vadodara, , India
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Asst Fbf Sacco
Milan, , Italy
Azienda Ospedale Università di Padova
Padua, , Italy
Humanitas Research Hospital
Rozzano, , Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
Ospedale San Lazzaro PO Molinette
Torino, , Italy
CD8 Klinika
Kaunas, , Lithuania
UAB Ausros Medicinos Centras
Kaunas, , Lithuania
UAB "Alerginių susirgimų diagnostikos ir gydymo centras"
Vilnius, , Lithuania
Santaros KTC (klinikiniu tyrimu centras)
Vilnius, , Lithuania
Unidad de Investigación Cima S.a
Chihuahua City, , Mexico
Meidadvance Clinical
Chihuahua City, , Mexico
Cryptex
Cuauhtémoc, , Mexico
Centro de Investigación Medico Biologica
Guadalajara, , Mexico
CIMET
Guadalajara, , Mexico
Panamerican Guadalajara
Guadalajara, , Mexico
Centro de Desarrollo Biomédico
Mérida, , Mexico
Mérida Investigación Clínica
Mérida, , Mexico
Eukarya Pharmasite
Monterrey, , Mexico
CECYPE
Morelia, , Mexico
Unidad de Medicina Especializada
San Juan del Río, , Mexico
FAICIC
Veracruz, , Mexico
AmdsterdamUMC locatie AMC
Amsterdam, , Netherlands
Bravis Hospital
Roosendaal, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Optimal Clinical Trials - Central
Auckland, , New Zealand
Pcrn Chch
Christchurch, , New Zealand
Momentum Clinical Research Dunedin
Dunedin, , New Zealand
Lakeland Clinical Trials - Waikato
Hamilton, , New Zealand
velocity Nova Sp. z o.o.
Nelson, , New Zealand
Pacific Clinical Research Network Rotorua
Rotorua, , New Zealand
Momentum Clinical Research Tauranga
Tauranga, , New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt, , New Zealand
Klinika Dermatologii i Dermatologii Onkologicznej
Częstochowa, , Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, , Poland
Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska
Elblag, , Poland
Synexus Polska Sp. z o.o.
Gdansk, , Poland
Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
Grodzisk Mazowiecki, , Poland
Provita Sp zoo
Katowice, , Poland
Centrum Medyczne "All-Med" Badania Kliniczne
Krakow, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Malopolskie Centrum Alergologii
Krakow, , Poland
Uniwersytet Medyczny w Łodzi - Centrum Wsparcia Badań Klinicznych
Lodz, , Poland
Velocity Nova Sp. z o.o.
Lublin, , Poland
Pro Life Medica ETG Lublin
Lublin, , Poland
DERMEDIC Iwona Zdybska
Lublin, , Poland
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
Lublin, , Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, , Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, , Poland
Medicome Sp. Z O.O.
Oświęcim, , Poland
Centrum Alergologii Teresa Hofman Sp. z.o.o.
Poznan, , Poland
EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium
Poznan, , Poland
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
Poznan, , Poland
Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
Rzeszów, , Poland
EMED Centrum Usług Medycznych Ewa Śmiałek
Rzeszów, , Poland
ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
Tarnów, , Poland
Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
Warsaw, , Poland
Synexus Polska Sp. z o.o.
Warsaw, , Poland
ETG Warszawa
Warsaw, , Poland
MAXDERM s.r.o.
Bardejov, , Slovakia
Cliniq s.r.o.
Bratislava, , Slovakia
Derma therapy spol. s.r.o.
Bratislava, , Slovakia
ALERSA, sro
Košice, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Puerta del Mar
Cadiz, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Clinica Universidad Navarra- Madrid
Madrid, , Spain
Hospital 12 De Octubre
Madrid, , Spain
Hospital Universitario Fundación Alcorcón
Madrid, , Spain
Clinica Universidad Navarra- Pamplona
Pamplona, , Spain
Complejo Hospitalario Universitario de Pontevedra- Centro Especialidades de Mollabao
Pontevedra, , Spain
Hospital Quironsalud Madrid
Pozuelo de Alarcón, , Spain
Hospital universitario Virgen Macarena
Seville, , Spain
FutureMeds Sevilla
Seville, , Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital de Manises
Valencia, , Spain
Siriraj Hospital
Bangkok Noi, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Thammasat University Hospital
Khlong Luang, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Hôpital Hédi Chaker
Sfax, , Tunisia
La Rabta Hospital
Tunis, , Tunisia
Habib Thameur Hospital
Tunis, , Tunisia
Southmead Hospital
Bristol, , United Kingdom
Velocity Clinical Research - Bristol
Bristol, , United Kingdom
Cambridge University Hospitals, Addenbrooke's Hospital
Cambridge, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Velocity Clinical Research High Wycombe
High Wycombe, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
The Royal London Hospital
London, , United Kingdom
Velocity Clinical Research, North London - PPDS
North Finchley, , United Kingdom
Virtual Clinical Trials Centre, The Stables
Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Velocity Clinical Research - Romford
Romford, , United Kingdom
Pinderfields Hospital
Wakefield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Courtney Hensel
Role: primary
Jill Case
Role: primary
David Johnson
Role: primary
Jazzmen Wilson
Role: primary
Eric Stanford
Role: primary
Mariola Rzymek
Role: primary
Marta Popławska
Role: primary
Anna Mielniczuk
Role: primary
Mariola Wojtasiak
Role: primary
Joanna Wiusniewska
Role: primary
Magdalena Paruch
Role: primary
Natalia Kopec
Role: primary
Eliza Kaczanowska-Grabowska
Role: primary
Samantha Parks
Role: primary
Heather Nisley
Role: primary
Jorge Quesada Aguilera
Role: primary
Ciara Thomas
Role: primary
Stephen Fuller
Role: primary
Tami McCreight
Role: primary
Alyssa Roberts
Role: primary
Violet Hernandez
Role: primary
Tatyana Palmer
Role: primary
Esther Kwon
Role: primary
Andrea Urrutia
Role: primary
Ellice Armstrong
Role: primary
Lori Martinez
Role: primary
Sophia Quiroz
Role: primary
Mallory Hull
Role: primary
Liz Wilson
Role: primary
Taimi Fernandez
Role: primary
Samantha Ayoub
Role: primary
Ivette Cuevas
Role: primary
Wilfredo Ramirez
Role: primary
Yennifer Machado
Role: primary
Leidy Caballero
Role: primary
Shanae Brown
Role: primary
Stacy Bell
Role: primary
Camila Linares
Role: primary
Lisbet Rodriguez
Role: primary
Yassel Hernandez
Role: primary
Rosemarie Acuna
Role: primary
Catherine Renee Smith
Role: primary
Kevin Peterson
Role: primary
Jordan Greene
Role: primary
Dalena Lien
Role: primary
Shellie Sackman
Role: primary
Rebeca Tojo Suarez
Role: primary
Stephanie Oliver
Role: primary
Jennifer Nelson
Role: primary
Shriya Karmarkar
Role: primary
Karina Carle
Role: primary
Jing Xiong
Role: primary
Ashley Lay
Role: primary
Tarisa Mantia
Role: primary
Samantha Johnson
Role: primary
Melba Ventura
Role: primary
Luis Paredes
Role: primary
Vikash Mandania
Role: primary
Adugna Deboch
Role: primary
Mithun Mishu
Role: primary
Robert Mackovick
Role: primary
Kristina Richwine
Role: primary
Caroline DiGiulio
Role: primary
Elisa Hernandez
Role: primary
Alivia Hernandez
Role: primary
Jonathan Joseph
Role: primary
DeAnn Wilson-Sims
Role: primary
Simone Halisky
Role: primary
Maria Rast
Role: primary
Linda Brusell
Role: primary
Sabina Neupane
Role: primary
William He
Role: primary
Nicola Miller
Role: primary
Olivia Pearson
Role: primary
Nadeeja Atapattu
Role: primary
Ashlee Lawson
Role: primary
Margaret Anders
Role: primary
Madeleine Supranowicz
Role: primary
Emma Jackson
Role: primary
Shahira Mosaddiq
Role: primary
Melissa Markos
Role: primary
Liam Tran
Role: primary
Vasilka Nakova
Role: primary
Elena Kalfova
Role: primary
Krasimira Vasileva
Role: primary
Yordanka Lukaeva
Role: primary
Silviya Novakova
Role: primary
Martina Nikolova
Role: primary
Kiril Manolov
Role: primary
Jaklin Mandilova
Role: primary
Diyana Titova
Role: primary
Monika Balabanova
Role: primary
Monika Spirova
Role: primary
Alex Fam
Role: primary
Angela Tycholaz
Role: primary
Shahira Mosaddiq
Role: primary
Angela Tycholaz
Role: primary
Roberta Maragno
Role: primary
Christina Craig
Role: primary
Morgan Monk
Role: primary
Brooke Butler
Role: primary
Seena Chacko
Role: primary
Chandni Shah
Role: primary
Lindsay Douglas
Role: primary
Burha Kabbir
Role: primary
Macia Yunon
Role: primary
Andréanne St-Cyr
Role: primary
Helen Pinto
Role: primary
Eliza Quezada
Role: primary
Ximen Vargas
Role: primary
Alejandra Rivera
Role: primary
Erika Orellana
Role: primary
Beatriz Díaz
Role: primary
Ana Maria del Fierro
Role: primary
Claudia Rojas
Role: primary
Eileen Pacheco
Role: primary
Claudia Asela
Role: primary
Diana Figueroa
Role: primary
Julieth Garzon
Role: primary
Leisa Florez
Role: primary
Osmith Amaya
Role: primary
Natasa Skocibusic
Role: primary
Ivan Domitrovic
Role: primary
Mariam Ghughunishvili
Role: primary
Giorgi Shengelidze
Role: primary
Salome Kharitonashvili
Role: primary
Mariam Tsertsvadze
Role: primary
Elke Gärtner
Role: primary
Johanna Lütjann
Role: primary
Julia Welle
Role: primary
Jose Garcia
Role: primary
Lars Raddatz
Role: primary
Sandra Wojte
Role: primary
Hiroko Ueda
Role: primary
Birgit Scholz
Role: backup
Jessica Bauriedl
Role: primary
Carina Jürs
Role: primary
Marlena Hawro
Role: primary
Susanne Melchers
Role: primary
Katrin Kieslich
Role: primary
Sarah Reinke
Role: backup
Benjamin Unkel
Role: primary
Gabriele Blank
Role: primary
Emerencia Tokajine Szebenszki
Role: primary
Beatrix Tajthy
Role: primary
Balazs TEREK
Role: primary
Vinod Vora
Role: primary
Bijal Shah
Role: primary
Pratiksha Shahakar
Role: primary
Deepak Ghumare
Role: primary
Pranjali Sutar
Role: primary
Devesh Joshi
Role: primary
Inzimam Ullah
Role: primary
Radhika Vavadiya
Role: primary
Pareek Nidhi
Role: primary
Amol Patil
Role: primary
Jyotibrahma Samal
Role: primary
Manju Jonwal
Role: primary
Fanus Fathima Iyaz
Role: primary
Saylee Baravkar
Role: primary
Ronak Shah
Role: primary
Emanuele Cozzani
Role: primary
Margherita Faenzi
Role: primary
Federica Ruin
Role: primary
Morena Meringo
Role: primary
Roberta Parente
Role: primary
Giada de angeli
Role: primary
Renata Ponti
Role: primary
Jurate Staikuniene - Kozonis
Role: primary
Edita Gasiuniene
Role: primary
Auksė Zinkevičienė
Role: primary
Laura Malinauskiene
Role: primary
Flor Gómez Godina
Role: primary
Nicol Puente
Role: primary
Jaqueline Serrano
Role: primary
Mirna Velasquez Arce
Role: primary
Juan Pablo Fonseca
Role: primary
Gabriela Sierra
Role: primary
Victor Hugo Lizama
Role: primary
Carlos Hernadez
Role: primary
Minereva Gómez
Role: primary
Jaqueline Espino
Role: primary
Carlos Alberto García
Role: primary
Astrid Hernández
Role: primary
Danny Cohn
Role: primary
Anne de Meijer
Role: primary
Heike Röckmann
Role: primary
Paul Grist
Role: primary
Olivia Rule
Role: primary
Loren Folland
Role: primary
Janice Phillips
Role: primary
Esme Justo
Role: primary
Deidre Monga
Role: primary
Kristin Sander
Role: primary
Stella Moon
Role: primary
Adrianna Jelonek
Role: primary
Katarzyna Godlewska
Role: primary
Karolina Leszczynska
Role: primary
Aleksandra Wasiewicz
Role: primary
Anna Witas
Role: primary
Agnieszka Pruszynska
Role: primary
Alicja Wolska-Krol
Role: primary
Klaudia Augustyn-Rak
Role: primary
Iwona Kobielusz-Gembala
Role: primary
Anna Hofmann
Role: primary
Kinga Kieronczyk
Role: primary
Michal Springer
Role: primary
Magdalena Sapa
Role: primary
Katarzyna Smialek
Role: primary
Anna Maj
Role: primary
Izabela Dubiel
Role: primary
Anna Zaradkiewicz
Role: primary
Justyna Szymańska
Role: primary
Renata Hodabova
Role: primary
Zuzana Duliakova
Role: primary
Sylvia Strbova
Role: primary
Lenka Botonkova
Role: primary
Barbora Lukacova
Role: primary
Silvia Sanchez Serrano
Role: primary
Isabela Capote
Role: primary
Noelia Aylagas
Role: primary
Daniel Salinas
Role: primary
María del Mar Onteniente
Role: primary
Mar Peregrina
Role: primary
Saioa Elizalde Baines
Role: primary
Lucia Vilanova Trillo
Role: primary
Carolina Yribarnegaray
Role: primary
Pilar Haya
Role: primary
Beatriz Parrillo
Role: primary
Teresa García-Donas
Role: primary
Airana Sein
Role: primary
Marta Moya Moya
Role: primary
María Solera
Role: backup
Thanyalak Ganjiang
Role: primary
Arunprapa Wienglor
Role: primary
Suvaraporn Sae-lim
Role: primary
Pattaravadee Chaiyasuk
Role: primary
Mouna Turki
Role: primary
Nourchene Toukebri
Role: primary
Sonia Chouaib
Role: primary
Janet Wong
Role: primary
Siddiqa Uddin, BS8 2RA
Role: primary
Ross Beech
Role: primary
Pasqua Piluzza
Role: primary
Katharine Sharp
Role: primary
Sivagami Muthiah
Role: primary
Eileen O'Grady
Role: primary
Musa Krubally
Role: primary
Sivagami Muthiah
Role: primary
Heather Howarth
Role: primary
Jane Evely
Role: primary
Esme Justo
Role: primary
Navya Poka
Role: primary
Zuzana Duliakova
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513210-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
CDX0159-13
Identifier Type: -
Identifier Source: org_study_id