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: Recruiting
Location: See all (241) 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
RECRUITING
Cullman
Arkansas
Burke Pharmaceutical Research
WITHDRAWN
Hot Springs
Arizona
Research Solutions of Arizona PC
RECRUITING
Litchfield Park
Center for Dermatology & Plastic Surgery
RECRUITING
Scottsdale
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
RECRUITING
Scottsdale
California
Kern Research, Inc.
RECRUITING
Bakersfield
California Allergy and Asthma Medical Group
RECRUITING
Los Angeles
LA Universal Research Center, Inc.
RECRUITING
Los Angeles
UCLA Clinical Trials Contracts & Strategic Relations
RECRUITING
Los Angeles
Allergy and Asthma Associates of Southern Cal
RECRUITING
Mission Viejo
Huntington Asthma & Allergy Center
RECRUITING
Pasadena
Apex Clinical Research
RECRUITING
San Diego
University Clinical Trials
RECRUITING
San Diego
WR-MCCR
RECRUITING
San Diego
Clinical Science Institute
RECRUITING
Santa Monica
Raffi Tachdjian MD, Inc
RECRUITING
Santa Monica
Colorado
Clarity Dermatology, PLLC
RECRUITING
Castle Rock
Asthma and Allergy Associates
RECRUITING
Colorado Springs
Florida
ClearlyDerm Boca Raton - ClinEdge - PPDS
RECRUITING
Boca Raton
Driven Research LLC
RECRUITING
Coral Gables
Palm Beach Dermatology Group
RECRUITING
Delray Beach
Dolphin Medical Research
RECRUITING
Doral
Dade Florida Clinical Research Center
RECRUITING
Miami
South FL Clinical Research LLC
RECRUITING
Miami
Deluxe Health Center
RECRUITING
Miami Lakes
Revival Clinical Research
RECRUITING
Orlando
International Clinical Research - FL LLC
RECRUITING
Sanford
Allergy and Asthma Diagnostic treatment Center - CRN - PPDS
RECRUITING
Tallahassee
D&H Tamarac Research Center, LLC
RECRUITING
Tamarac
Advanced Clinical Research Institute (ACRI) - Florida
RECRUITING
Tampa
Deluxe Health Center
RECRUITING
Tampa
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
RECRUITING
Tampa
Olympian Clinical Research
RECRUITING
Tampa
University of South Florida
RECRUITING
Tampa
Georgia
Lane Dermatology Research - Centricity - PPDS
RECRUITING
Columbus
Skin Care Physicians of Georgia
RECRUITING
Macon
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
Sneeze Wheeze and Itch Associates LLC
RECRUITING
Normal
Indiana
The Indiana Clinical Trials Center, PC
RECRUITING
Plainfield
South Bend Clinic
RECRUITING
South Bend
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Henry J. Kanarek - Allergy,Asthma&Immunology
RECRUITING
Overland Park
Kentucky
Allergy & Asthma Associates
RECRUITING
Lexington
Louisiana
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
RECRUITING
Baton Rouge
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
RECRUITING
Towson
Michigan
Derm Institute of Western Michigan
RECRUITING
Caledonia
Clarkston Skin Research - Clarkston
RECRUITING
Clarkston
Grekin Skin Institute
RECRUITING
Warren
Missouri
Midwest Clinical Research, LLC
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Nebraska
Skin Specialists PC
RECRUITING
Omaha
New Jersey
Hudson-Essex Allergy
RECRUITING
Belleville
Impact Medical / Circuit Clinical
RECRUITING
Paramus
Impact Medical / Circuit Clinical
RECRUITING
Riverdale
New York
Equity Medical LLC
RECRUITING
New York
OptiSkin Medical
RECRUITING
New York
Ohio
Optima Research
RECRUITING
Boardman
Optimed Research Ltd - ClinEdge - PPDS
RECRUITING
Columbus
Pennsylvania
Penn State Health Milton Hershey Med Cen
RECRUITING
Hershey
Rhode Island
Clinical Partners LLC
RECRUITING
Johnston
Texas
University of Texas Health McGovern Medical
RECRUITING
Bellaire
Western Sky Medical Research
RECRUITING
El Paso
Austin Institute for Clinical Research, Inc.
RECRUITING
Pflugerville
Rainey & Finklea San Antonio Dermatology
RECRUITING
San Antonio
Utah
Allergy Associates of Utah - Sandy
RECRUITING
Murray
Jordan Valley Dermatology Center-South Jordan
RECRUITING
South Jordan
Kalo Clinical Research
RECRUITING
West Valley City
Virginia
Virginia Dermatology and Skin Cancer Center - Norfolk
RECRUITING
Norfolk
Other Locations
Australia
Box Hill Hospital
RECRUITING
Box Hill
Princess Alexandra Hospital
RECRUITING
Brisbane
Novatrials
RECRUITING
Charlestown
Cornerstone Dermatology
RECRUITING
Coorparoo
Skin and Cancer Foundation - The Skin Hospital
RECRUITING
Darlinghurst
Dr Rodney Sinclair Pty Ltd
RECRUITING
East Melbourne
St George Dermatology and Skin Cancer Center
RECRUITING
Kogarah
The Alfred Hospital
RECRUITING
Melbourne
The Royal Melbourne Hospital
RECRUITING
Parkville
Momentum Clinical Research Darlinghurst
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Westmead
Veracity Clinical Research Pty Ltd
RECRUITING
Woolloongabba
Bulgaria
Medical Centre Asklepii OOD
RECRUITING
Dupnitsa
Medical Center - Pulmo 2018
RECRUITING
Haskovo
Medical Center Medconsult Pleven
RECRUITING
Lovech
Multiprofile Hospital for Active Treatment - Pazardzhik AD
RECRUITING
Pazardzhik
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
RECRUITING
Plovdiv
Medical Center Prolet
RECRUITING
Rousse
Medical Center Unimed EOOD
RECRUITING
Sevlievo
Diagnostic and Consultative Center Aleksandrovska EOOD
RECRUITING
Sofia
Diagnostic-consultative center Ascendent EOOD
RECRUITING
Sofia
Diagnostic-Consultative Centre Convex EOOD
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL
RECRUITING
Sofia
Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc.
RECRUITING
Edmonton
Rejuvenation Dermatology Edmonton South
RECRUITING
Edmonton
Vida Clinical Research
RECRUITING
Edmonton
LEADER research
RECRUITING
Hamilton
DermEffects
RECRUITING
London
North Bay Dermatology Centre
RECRUITING
North Bay
Ottawa Allergy Research Corporation
RECRUITING
Ottawa
Centre de Recherche Saint-Louis (Québec)
RECRUITING
Québec
York Dermatology Clinic & Research Centre
RECRUITING
Richmond Hill
Saskatoon Dermatology Centre
RECRUITING
Saskatoon
North York Research Inc.
RECRUITING
Toronto
Joel Liem Medicine Professional Corporation
RECRUITING
Windsor
Chile
Clinica MEDS La Dehesa
RECRUITING
Lo Barnechea
Hospital Base San Jose de Osorno
RECRUITING
Osorno
Enroll SpA - Dr. Manuel Barros Borgono
RECRUITING
Providencia
Centro Internacional de Estudios Clinicos (CIEC)
RECRUITING
Recoleta
Clinica Davila - Recoleta
RECRUITING
Recoleta
BIOCINETIC Ltda
RECRUITING
Santiago
Medical Skin Center
RECRUITING
Viña Del Mar
Dermacross Clinica Dermatologica
RECRUITING
Vitacura
Colombia
Centro Integral de Reumatologia Del Caribe
RECRUITING
Barranquilla
Centro de Inmunología y Genética - CIGE S.A.S
RECRUITING
Medellín
Fundación Centro de Investigation Clínica CIC
RECRUITING
Medellín
Hospital Alma Mater de Antioquia
RECRUITING
Medellín
Hospital General de Medellín Luz Castro de Gutiérrez
RECRUITING
Medellín
Fundación Hospital Universidad del Norte
RECRUITING
Soledad
Croatia
Special Hospital Medico
RECRUITING
Rijeka
Solmed Clinic
RECRUITING
Zagreb
Georgia
David Abuladze Georgian Italian Clinic
RECRUITING
Tbilisi
LTD Center of Allergy and Immunology
RECRUITING
Tbilisi
LTD Healthy Future
RECRUITING
Tbilisi
LTD Multiprofile Clinic Consilium Medulla
RECRUITING
Tbilisi
Germany
Universitätsklinikum der RWTH Aachen Hautklinik
RECRUITING
Aachen
Fachklinik Bad Bentheim
RECRUITING
Bad Bentheim
Emovis GmbH
RECRUITING
Berlin
Universitätsklinikum Bonn
RECRUITING
Bonn
Klinische Forschung Dresden GmbH
RECRUITING
Dresden
Universitätsklinikum Carl Gustav Carus an der TU Dresden
RECRUITING
Dresden
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Universitätsklinikum Essen
RECRUITING
Essen
Eurofins bioskin Research Center Dermalology
RECRUITING
Hamburg
UKSH Lübeck, Institut für Entzündungsmedizin
RECRUITING
Lübeck
Universitätsklinikum Mannheim
RECRUITING
Mannheim
Universitätsklinikum Münster
RECRUITING
Münster
Hautarztpraxis Dariusch Mortazawi
RECRUITING
Remscheid
Universitäts-Hautklinik, Studienzentrum Immundermatologie
RECRUITING
Tübingen
Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
RECRUITING
Debrecen
Szent-Gyorgyi Albert Klinikai Kozpont
RECRUITING
Szeged
Allergo-Derm Bakos Kft.
RECRUITING
Szolnok
India
B. J. Medical College and Civil Hospital
RECRUITING
Ahmedabad
Panchshil Hospital - Ahmedabad
RECRUITING
Ahmedabad
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
RECRUITING
Belagavi
All India Institute of Medical Sciences
RECRUITING
Bhubaneswar
Excelcare Hospital
RECRUITING
Jaipur
G.S.V.M. Medical College - Kanpur
RECRUITING
Kanpur
K R Hospital
RECRUITING
Mysore
Shree Hospital & Critical Care Centre
RECRUITING
Nagpur
Assured Care Plus Hospital
RECRUITING
Nashik
Deenanath Mangeshkar Hospital and Research Centre
RECRUITING
Pune
Oyster & Pearl Hospitals
RECRUITING
Pune
Nirmal Hospital PVT LTD
RECRUITING
Surat
Medical College Baroda & SSG Hospital
RECRUITING
Vadodara
Sumandeep Vidyapeeth University - Dhiraj Hospital
RECRUITING
Vadodara
Italy
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
Asst Fbf Sacco
RECRUITING
Milan
Azienda Ospedale Università di Padova
RECRUITING
Padua
Humanitas Research Hospital
RECRUITING
Rozzano
AOU San Giovanni di Dio e Ruggi d'Aragona
RECRUITING
Salerno
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Ospedale San Lazzaro PO Molinette
RECRUITING
Torino
Lithuania
CD8 Klinika
RECRUITING
Kaunas
UAB Ausros Medicinos Centras
RECRUITING
Kaunas
Santaros KTC (klinikiniu tyrimu centras)
RECRUITING
Vilnius
UAB Alerginių susirgimų diagnostikos ir gydymo centras
RECRUITING
Vilnius
Mexico
Cryptex
RECRUITING
Cuauhtémoc
Eukarya Pharmasite
RECRUITING
Monterrey
CECYPE
RECRUITING
Morelia
Unidad de Medicina Especializada
RECRUITING
San Juan Del Río
Netherlands
AmdsterdamUMC locatie AMC
RECRUITING
Amsterdam
Bravis Hospital
RECRUITING
Roosendaal
University Medical Center Utrecht
RECRUITING
Utrecht
New Zealand
Optimal Clinical Trials - Central
RECRUITING
Auckland
Pcrn Chch
RECRUITING
Christchurch
Momentum Clinical Research Dunedin
RECRUITING
Dunedin
Lakeland Clinical Trials - Waikato
RECRUITING
Hamilton
velocity Nova Sp. z o.o.
RECRUITING
Nelson
Pacific Clinical Research Network Rotorua
RECRUITING
Rotorua
Momentum Clinical Research Tauranga
RECRUITING
Tauranga
Lakeland Clinical Trials Wellington
RECRUITING
Upper Hutt
Poland
Centrum Medyczne Pratia Częstochowa
RECRUITING
Częstochowa
Klinika Dermatologii i Dermatologii Onkologicznej
RECRUITING
Częstochowa
Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska
RECRUITING
Elblag
Synexus Polska Sp. z o.o.
RECRUITING
Gdansk
Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
RECRUITING
Grodzisk Mazowiecki
Provita Sp zoo
RECRUITING
Katowice
Centrum Medyczne All-Med Badania Kliniczne
RECRUITING
Krakow
Centrum Medyczne Plejady
RECRUITING
Krakow
Malopolskie Centrum Alergologii
RECRUITING
Krakow
Uniwersytet Medyczny w Łodzi - Centrum Wsparcia Badań Klinicznych
RECRUITING
Lodz
DERMEDIC Iwona Zdybska
RECRUITING
Lublin
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
RECRUITING
Lublin
Pro Life Medica ETG Lublin
RECRUITING
Lublin
Velocity Nova Sp. z o.o.
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny w Opolu
RECRUITING
Opole
Medicome Sp. Z O.O.
RECRUITING
Oświęcim
Centrum Alergologii Teresa Hofman Sp. z.o.o.
RECRUITING
Poznan
EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium
RECRUITING
Poznan
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
RECRUITING
Poznan
EMED Centrum Usług Medycznych Ewa Śmiałek
RECRUITING
Rzeszów
Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
RECRUITING
Rzeszów
ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
RECRUITING
Tarnów
ETG Warszawa
RECRUITING
Warsaw
Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
RECRUITING
Warsaw
Synexus Polska Sp. z o.o.
RECRUITING
Warsaw
Slovakia
MAXDERM s.r.o.
RECRUITING
Bardejov
Cliniq s.r.o.
RECRUITING
Bratislava
Derma therapy spol. s.r.o.
RECRUITING
Bratislava
ALERSA, sro
RECRUITING
Košice
Fakultna nemocnica Trnava
RECRUITING
Trnava
Spain
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitari Puerta del Mar
RECRUITING
Cadiz
Clinica Universidad Navarra- Madrid
RECRUITING
Madrid
Hospital 12 De Octubre
RECRUITING
Madrid
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario Fundación Alcorcón
RECRUITING
Madrid
Clinica Universidad Navarra- Pamplona
RECRUITING
Pamplona
Complejo Hospitalario Universitario de Pontevedra- Centro Especialidades de Mollabao
RECRUITING
Pontevedra
Hospital Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
FutureMeds Sevilla
RECRUITING
Seville
Hospital universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitario de Torrejón
RECRUITING
Torrejón De Ardoz
Hospital de Manises
RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
Thailand
Siriraj Hospital
RECRUITING
Bangkok Noi
Maharaj Nakorn Chiang Mai Hospital
RECRUITING
Chiang Mai
Thammasat University Hospital
RECRUITING
Khlong Luang
Khon Kaen University
RECRUITING
Khon Kaen
Tunisia
Hôpital Hédi Chaker
RECRUITING
Sfax
Habib Thameur Hospital
RECRUITING
Tunis
La Rabta Hospital
RECRUITING
Tunis
United Kingdom
Cambridge University Hospitals, Addenbrooke's Hospital
RECRUITING
Cambridge
Queen Elizabeth University Hospital
RECRUITING
Glasgow
St James's University Hospital
RECRUITING
Leeds
The Royal London Hospital
RECRUITING
London
Velocity Clinical Research, North London - PPDS
RECRUITING
North Finchley
Virtual Clinical Trials Centre, The Stables
RECRUITING
Oxford
University Hospitals Plymouth NHS Trust
RECRUITING
Plymouth
Royal Berkshire Hospital
RECRUITING
Reading
Contact Information
Primary
Celldex Therapeutics
clinicaltrials@celldex.com
844-723-9363
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2027-04
Participants
Target number of participants: 915
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