A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)
Status: Active_not_recruiting
Location: See all (245) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Males and females, \>/= 18 years of age.
• Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
• CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
‣ The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
⁃ Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
⁃ UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
• Normal blood counts and liver function tests.
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.
• Participants with and without prior biologic experience are eligible.
Locations
United States
Alabama
Allervie Clinical Research - Cullman
Cullman
Arizona
Research Solutions of Arizona PC
Litchfield Park
Center for Dermatology & Plastic Surgery
Scottsdale
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
Scottsdale
California
Kern Research, Inc.
Bakersfield
California Allergy and Asthma Medical Group
Los Angeles
LA Universal Research Center, Inc.
Los Angeles
UCLA Clinical Trials Contracts & Strategic Relations
Los Angeles
Allergy and Asthma Associates of Southern Cal
Mission Viejo
Huntington Asthma & Allergy Center
Pasadena
Apex Clinical Research
San Diego
University Clinical Trials
San Diego
WR-MCCR
San Diego
Clinical Science Institute
Santa Monica
Raffi Tachdjian MD, Inc
Santa Monica
Colorado
Clarity Dermatology, PLLC
Castle Rock
Asthma and Allergy Associates
Colorado Springs
Florida
Driven Research LLC
Coral Gables
Palm Beach Dermatology Group
Delray Beach
Dolphin Medical Research
Doral
Dade Florida Clinical Research Center
Miami
South FL Clinical Research LLC
Miami
Deluxe Health Center
Miami Lakes
Revival Clinical Research
Orlando
International Clinical Research - FL LLC
Sanford
D&H Tamarac Research Center, LLC
Tamarac
Advanced Clinical Research Institute (ACRI) - Florida
Tampa
Deluxe Health Center
Tampa
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa
Olympian Clinical Research
Tampa
University of South Florida
Tampa
Georgia
Lane Dermatology Research - Centricity - PPDS
Columbus
Skin Care Physicians of Georgia
Macon
Idaho
Treasure Valley Medical Research
Boise
Illinois
Rush University Medical Center
Chicago
Sneeze Wheeze and Itch Associates LLC
Normal
Indiana
The Indiana Clinical Trials Center, PC
Plainfield
South Bend Clinic
South Bend
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
Equity Medical
Bowling Green
Allergy & Asthma Associates
Lexington
Louisiana
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
Baton Rouge
Massachusetts
Brigham and Women's Hospital
Boston
Maryland
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
Towson
Michigan
Derm Institute of Western Michigan
Caledonia
Clarkston Skin Research - Clarkston
Clarkston
Missouri
Midwest Clinical Research, LLC
St Louis
Washington University School of Medicine
St Louis
Nebraska
Skin Specialists PC
Omaha
New Jersey
Hudson-Essex Allergy
Belleville
Impact Medical / Circuit Clinical
Paramus
Impact Medical / Circuit Clinical
Riverdale
New York
Equity Medical LLC
New York
OptiSkin Medical
New York
Ohio
Optima Research
Boardman
Optimed Research Ltd - ClinEdge - PPDS
Columbus
Pennsylvania
Penn State Health Milton Hershey Med Cen
Hershey
Rhode Island
Clinical Partners LLC
Johnston
Texas
Western Sky Medical Research
El Paso
Austin Institute for Clinical Research, Inc.
Pflugerville
Rainey & Finklea San Antonio Dermatology
San Antonio
Utah
Allergy Associates of Utah - Sandy
Murray
Kalo Clinical Research
West Valley City
Other Locations
Australia
Box Hill Hospital
Box Hill
Princess Alexandra Hospital
Brisbane
Novatrials
Charlestown
Cornerstone Dermatology
Coorparoo
Skin and Cancer Foundation - The Skin Hospital
Darlinghurst
Dr Rodney Sinclair Pty Ltd
East Melbourne
St George Dermatology and Skin Cancer Center
Kogarah
The Alfred Hospital
Melbourne
The Royal Melbourne Hospital
Parkville
Westmead Hospital
Westmead
Veracity Clinical Research Pty Ltd
Woolloongabba
Bulgaria
Medical Centre Asklepii OOD
Dupnitsa
Medical Center - Pulmo 2018
Haskovo
Medical Center Medconsult Pleven
Lovech
Multiprofile Hospital for Active Treatment - Pazardzhik AD
Pazardzhik
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv
Medical Center Prolet
Rousse
Medical Center Unimed EOOD
Sevlievo
Diagnostic and Consultative Center Aleksandrovska EOOD
Sofia
Diagnostic-consultative center Ascendent EOOD
Sofia
Diagnostic-Consultative Centre Convex EOOD
Sofia
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL
Sofia
Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton
Rejuvenation Dermatology Edmonton South
Edmonton
Vida Clinical Research
Edmonton
LEADER research
Hamilton
Kingston Health Science Center
Kingston
DermEffects
London
North Bay Dermatology Centre
North Bay
Ottawa Allergy Research Corporation
Ottawa
Centre de Recherche Saint-Louis (Québec)
Québec
York Dermatology Clinic & Research Centre
Richmond Hill
Saskatoon Dermatology Centre
Saskatoon
North York Research Inc.
Toronto
Joel Liem Medicine Professional Corporation
Windsor
Chile
Clinica MEDS La Dehesa
Lo Barnechea
Hospital Base San Jose de Osorno
Osorno
Enroll SpA - Dr. Manuel Barros Borgono
Providencia
Centro Internacional de Estudios Clinicos (CIEC)
Recoleta
Clinica Davila - Recoleta
Recoleta
BIOCINETIC Ltda
Santiago
Medical Skin Center
Viña Del Mar
Dermacross Clinica Dermatologica
Vitacura
Colombia
Centro Integral de Reumatologia Del Caribe
Barranquilla
Centro de Inmunología y Genética - CIGE S.A.S
Medellín
Fundación Centro de Investigation Clínica CIC
Medellín
Hospital Alma Mater de Antioquia
Medellín
Hospital General de Medellín Luz Castro de Gutiérrez
Medellín
Fundación Hospital Universidad del Norte
Soledad
Croatia
Special Hospital Medico
Rijeka
Solmed Clinic
Zagreb
Georgia
David Abuladze Georgian Italian Clinic
Tbilisi
LTD Center of Allergy and Immunology
Tbilisi
LTD Healthy Future
Tbilisi
LTD Multiprofile Clinic Consilium Medulla
Tbilisi
Germany
Universitätsklinikum der RWTH Aachen Hautklinik
Aachen
Fachklinik Bad Bentheim
Bad Bentheim
Emovis GmbH
Berlin
Universitätsklinikum Bonn
Bonn
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden
Universitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinikum Essen
Essen
Eurofins bioskin Research Center Dermalology
Hamburg
UKSH Lübeck, Institut für Entzündungsmedizin
Lübeck
Universitätsklinikum Mannheim
Mannheim
Universitätsklinikum Münster
Münster
Hautarztpraxis Dariusch Mortazawi
Remscheid
Universitäts-Hautklinik, Studienzentrum Immundermatologie
Tübingen
Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen
Szent-Gyorgyi Albert Klinikai Kozpont
Szeged
Allergo-Derm Bakos Kft.
Szolnok
India
B. J. Medical College and Civil Hospital
Ahmedabad
Panchshil Hospital - Ahmedabad
Ahmedabad
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Belagavi
All India Institute of Medical Sciences
Bhubaneswar
Apex Hospitals Pvt Ltd
Jaipur
Excelcare Hospital
Jaipur
G.S.V.M. Medical College - Kanpur
Kanpur
K R Hospital
Mysore
Shree Hospital & Critical Care Centre
Nagpur
Assured Care Plus Hospital
Nashik
Deenanath Mangeshkar Hospital and Research Centre
Pune
Oyster & Pearl Hospitals
Pune
Nirmal Hospital PVT LTD
Surat
Medical College Baroda & SSG Hospital
Vadodara
Sumandeep Vidyapeeth University - Dhiraj Hospital
Vadodara
Italy
IRCCS Ospedale Policlinico San Martino
Genova
Asst Fbf Sacco
Milan
Azienda Ospedale Università di Padova
Padova
Humanitas Research Hospital
Rozzano
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno
IRCCS Policlinico San Donato
San Donato Milanese
Ospedale San Lazzaro PO Molinette
Torino
Lithuania
CD8 Klinika
Kaunas
UAB Ausros Medicinos Centras
Kaunas
Santaros KTC (klinikiniu tyrimu centras)
Vilnius
UAB Alerginių susirgimų diagnostikos ir gydymo centras
Vilnius
Mexico
Meidadvance Clinical
Chihuahua City
Unidad de Investigación Cima S.a
Chihuahua City
Cryptex
Cuauhtémoc
Centro de Investigación Medico Biologica
Guadalajara
CIMET
Guadalajara
Panamerican Guadalajara
Guadalajara
Centro de Desarrollo Biomédico
Mérida
Mérida Investigación Clínica
Mérida
Eukarya Pharmasite
Monterrey
CECYPE
Morelia
Unidad de Medicina Especializada
San Juan Del Río
FAICIC
Veracruz
Netherlands
AmdsterdamUMC locatie AMC
Amsterdam
Bravis Hospital
Roosendaal
University Medical Center Utrecht
Utrecht
New Zealand
Optimal Clinical Trials - Central
Auckland
Pcrn Chch
Christchurch
Momentum Clinical Research Dunedin
Dunedin
Lakeland Clinical Trials - Waikato
Hamilton
velocity Nova Sp. z o.o.
Nelson
Pacific Clinical Research Network Rotorua
Rotorua
Momentum Clinical Research Tauranga
Tauranga
Lakeland Clinical Trials Wellington
Upper Hutt
Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa
Klinika Dermatologii i Dermatologii Onkologicznej
Częstochowa
Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska
Elblag
Synexus Polska Sp. z o.o.
Gdansk
Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
Grodzisk Mazowiecki
Provita Sp zoo
Katowice
Centrum Medyczne All-Med Badania Kliniczne
Krakow
Centrum Medyczne Plejady
Krakow
Malopolskie Centrum Alergologii
Krakow
Uniwersytet Medyczny w Łodzi - Centrum Wsparcia Badań Klinicznych
Lodz
DERMEDIC Iwona Zdybska
Lublin
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
Lublin
Pro Life Medica ETG Lublin
Lublin
Velocity Nova Sp. z o.o.
Lublin
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól
Uniwersytecki Szpital Kliniczny w Opolu
Opole
Medicome Sp. Z O.O.
Oświęcim
Centrum Alergologii Teresa Hofman Sp. z.o.o.
Poznan
EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium
Poznan
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
Poznan
EMED Centrum Usług Medycznych Ewa Śmiałek
Rzeszów
Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
Rzeszów
ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
Tarnów
ETG Warszawa
Warsaw
Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
Warsaw
Synexus Polska Sp. z o.o.
Warsaw
Slovakia
MAXDERM s.r.o.
Bardejov
Derma therapy spol. s.r.o.
Bratislava
ALERSA, sro
Košice
Fakultna nemocnica Trnava
Trnava
Spain
Hospital del Mar
Barcelona
Hospital Universitari Puerta del Mar
Cadiz
Hospital 12 De Octubre
Madrid
Hospital Universitario de La Princesa
Madrid
Clinica Universidad Navarra- Pamplona
Pamplona
Hospital Quironsalud Madrid
Pozuelo De Alarcón
FutureMeds Sevilla
Seville
Hospital universitario Virgen Macarena
Seville
Hospital Universitario de Torrejón
Torrejón De Ardoz
Hospital de Manises
Valencia
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Thailand
Siriraj Hospital
Bangkok Noi
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Thammasat University Hospital
Khlong Luang
Khon Kaen University
Khon Kaen
Tunisia
Hôpital Hédi Chaker
Sfax
Habib Thameur Hospital
Tunis
La Rabta Hospital
Tunis
United Kingdom
Southmead Hospital
Bristol
Cambridge University Hospitals, Addenbrooke's Hospital
Cambridge
Western General Hospital
Edinburgh
Queen Elizabeth University Hospital
Glasgow
Velocity Clinical Research High Wycombe
High Wycombe
St James's University Hospital
Leeds
The Royal London Hospital
London
Velocity Clinical Research, North London - PPDS
North Finchley
Virtual Clinical Trials Centre, The Stables
Oxford
University Hospitals Plymouth NHS Trust
Plymouth
Royal Berkshire Hospital
Reading
Velocity Clinical Research - Romford
Romford
Pinderfields Hospital
Wakefield
Time Frame
Start Date: 2024-07-19
Completion Date: 2027-04
Participants
Target number of participants: 976
Treatments
Experimental: barzolvolimab 150 mg
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Experimental: barzolvolimab 300 mg
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Celldex Therapeutics