A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) (EMBARQ-CSU2)

March 24, 2026 updated by: Celldex Therapeutics

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.

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.

Study Type

Interventional

Enrollment (Actual)

976

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Charlestown, New South Wales, Australia, 2290
        • Novatrials
      • Darlinghurst, New South Wales, Australia, 2010
        • Skin and Cancer Foundation - The Skin Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St George Dermatology and Skin Cancer Center
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
      • Coorparoo, Queensland, Australia, 4151
        • Cornerstone Dermatology
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research Pty Ltd
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • East Melbourne, Victoria, Australia, 3002
        • Dr Rodney Sinclair Pty Ltd
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Medical Centre Asklepii OOD
      • Haskovo, Bulgaria, 6300
        • Medical Center - Pulmo 2018
      • Lovech, Bulgaria, 5500
        • Medical Center Medconsult Pleven
      • Pazardzhik, Bulgaria, 4400
        • Multiprofile Hospital for Active Treatment - Pazardzhik AD
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
      • Rousse, Bulgaria, 7000
        • Medical Center Prolet
      • Sevlievo, Bulgaria, 5400
        • Medical Center Unimed Eood
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
      • Sofia, Bulgaria, 1527
        • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"
      • Sofia, Bulgaria, 1202
        • Diagnostic-Consultative Center Ascendent Eood
      • Sofia, Bulgaria, 1431
        • Diagnostic and Consultative Center Aleksandrovska EOOD
      • Sofia, Bulgaria, 1680
        • Diagnostic-Consultative Centre Convex EOOD
  • Canada
      • Kingston, Canada, K7L 2V7
        • Kingston Health Science Center
      • Québec, Canada, G1W4R4
        • Centre de Recherche Saint-Louis (Québec)
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3S9
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
      • Edmonton, Alberta, Canada, T6H 4J8
        • Vida Clinical Research
      • Edmonton, Alberta, Canada, T6W 0J5
        • Rejuvenation Dermatology Edmonton South
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • LEADER research
      • London, Ontario, Canada, N6H 5L5
        • Dermeffects
      • North Bay, Ontario, Canada, P1B 3Z7
        • North Bay Dermatology Centre
      • Ottawa, Ontario, Canada, K1H1E4
        • Ottawa Allergy Research Corporation
      • Richmond Hill, Ontario, Canada, L4B 1L1
        • York Dermatology Clinic & Research Centre
      • Toronto, Ontario, Canada, M2N 3A6
        • North York Research Inc.
      • Windsor, Ontario, Canada, N8X 2G1
        • Joel Liem Medicine Professional Corporation
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7T0G3
        • Saskatoon Dermatology Centre
  • Chile
      • Lo Barnechea, Chile, 7691236
        • Clinica MEDS La Dehesa
      • Osorno, Chile, 5290000
        • Hospital Base San Jose de Osorno
      • Providencia, Chile, 7500000
        • Enroll SpA - Dr. Manuel Barros Borgono
      • Recoleta, Chile, 8420000
        • Clinica Davila - Recoleta
      • Recoleta, Chile, 8420383
        • Centro Internacional de Estudios Clínicos (CIEC)
      • Santiago, Chile, 8350595
        • BIOCINETIC Ltda
      • Vitacura, Chile, 7630000
        • Dermacross Clinica Dermatologica
      • Viña del Mar, Chile, 2520000
        • Medical Skin Center
  • Colombia
      • Barranquilla, Colombia, 8001
        • Centro Integral de Reumatologia Del Caribe
      • Medellín, Colombia, 50010
        • Hospital Alma Mater de Antioquia
      • Medellín, Colombia, 50012
        • Centro de Inmunología y Genética - CIGE S.A.S
      • Medellín, Colombia, 50015
        • Hospital General de Medellín Luz Castro de Gutiérrez
      • Medellín, Colombia, 50021
        • Fundación Centro de Investigation Clínica CIC
      • Soledad, Colombia, 83001
        • Fundación Hospital Universidad del Norte
  • Croatia
      • Rijeka, Croatia, 51000
        • Special Hospital Medico
      • Zagreb, Croatia, 10000
        • Solmed Clinic
  • Georgia
      • Tbilisi, Georgia, 0119
        • LTD" Healthy Future"
      • Tbilisi, Georgia, 0159
        • LTD "Center of Allergy and Immunology"
      • Tbilisi, Georgia, 0179
        • David Abuladze Georgian Italian Clinic
      • Tbilisi, Georgia, 0186
        • LTD "Multiprofile Clinic Consilium Medulla"
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum der RWTH Aachen Hautklinik
      • Bad Bentheim, Germany, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Germany, 10629
        • emovis GmbH
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
      • Hamburg, Germany, 20095
        • Eurofins bioskin Research Center Dermalology
      • Lübeck, Germany, 23538
        • UKSH Lübeck, Institut für Entzündungsmedizin
      • Mannheim, Germany, 68167
        • Universitätsklinikum Mannheim
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Remscheid, Germany, 42897
        • Hautarztpraxis Dariusch Mortazawi
      • Tübingen, Germany, 72076
        • Universitäts-Hautklinik, Studienzentrum Immundermatologie
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
      • Szeged, Hungary, 6725
        • Szent-Gyorgyi Albert Klinikai Kozpont
      • Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft.
  • India
      • Ahmedabad, India, 380005
        • Panchshil Hospital - Ahmedabad
      • Ahmedabad, India, 380016
        • B. J. Medical College and Civil Hospital
      • Belagavi, India, 590010
        • KLES Dr Prabhakar Kore Hospital & Medical Research Centre
      • Bhubaneswar, India, 751019
        • All India Institute of Medical Sciences
      • Jaipur, India, 302017
        • Apex Hospitals Pvt Ltd
      • Mysore, India, 570001
        • K R Hospital
      • Pune, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
      • Vadodara, India, 391760
        • Sumandeep Vidyapeeth University - Dhiraj Hospital
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt Ltd
      • Vadodara, Gujarat, India, 390001
        • Medical College Baroda & SSG Hospital
    • Maharashtra
      • Nagpur, Maharashtra, India, 440009
        • Shree Hospital & Critical Care Centre
      • Nashik, Maharashtra, India, 422101
        • Assured Care Plus Hospital
      • Pune, Maharashtra, India, 411005
        • Oyster & Pearl Hospitals
    • Rajasthan
      • Jaipur, Rajasthan, India, 302012
        • Excelcare Hospital
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208002
        • G.S.V.M. Medical College - Kanpur
  • Italy
      • Genova, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
      • Milan, Italy, 20157
        • Asst Fbf Sacco
      • Padua, Italy, 38068
        • Azienda Ospedale Universita Di Padova
      • Rozzano, Italy, 20089
        • Humanitas Research Hospital
      • Salerno, Italy, 84131
        • AOU San Giovanni di Dio e Ruggi d'Aragona
      • San Donato Milanese, Italy, 20097
        • IRCCS Policlinico San Donato
      • Torino, Italy, 10126
        • Ospedale San Lazzaro PO Molinette
  • Lithuania
      • Kaunas, Lithuania, LT-44192
        • CD8 Klinika
      • Kaunas, Lithuania, LT-49387
        • UAB Ausros Medicinos Centras
      • Vilnius, Lithuania, LT-08109
        • UAB "Alerginių susirgimų diagnostikos ir gydymo centras"
      • Vilnius, Lithuania, LT-08406
        • Santaros KTC (klinikiniu tyrimu centras)
  • Mexico
      • Chihuahua City, Mexico, 31200
        • Unidad de Investigación Cima S.a
      • Chihuahua City, Mexico, 31203
        • Meidadvance Clinical
      • Cuauhtémoc, Mexico, 06100
        • Cryptex
      • Guadalajara, Mexico, 44130
        • Centro de Investigación Medico Biologica
      • Guadalajara, Mexico, 44340
        • CIMET
      • Guadalajara, Mexico, 44670
        • Panamerican Guadalajara
      • Monterrey, Mexico, 64718
        • Eukarya PharmaSite
      • Morelia, Mexico, 58249
        • CECYPE
      • Mérida, Mexico, 97000
        • Centro de Desarrollo Biomedico
      • Mérida, Mexico, 97125
        • Merida Investigación Clínica
      • San Juan del Río, Mexico, 76800
        • Unidad de Medicina Especializada
      • Veracruz, Mexico, 91900
        • FAICIC
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • AmdsterdamUMC locatie AMC
      • Roosendaal, Netherlands, 4708 AE
        • Bravis Hospital
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • New Zealand
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials - Central
      • Christchurch, New Zealand, 8013
        • Pcrn Chch
      • Dunedin, New Zealand, 9016
        • Momentum Clinical Research Dunedin
      • Hamilton, New Zealand, 3200
        • Lakeland Clinical Trials - Waikato
      • Nelson, New Zealand, 7011
        • Velocity Nova Sp. z o.o.
      • Rotorua, New Zealand, 3010
        • Pacific Clinical Research Network Rotorua
      • Tauranga, New Zealand, 3110
        • Momentum clinical Research Tauranga
      • Upper Hutt, New Zealand, 5018
        • Lakeland Clinical Trials Wellington
  • Poland
      • Częstochowa, Poland, 42-217
        • Centrum Medyczne Pratia Częstochowa
      • Częstochowa, Poland, 42-202
        • Klinika Dermatologii i Dermatologii Onkologicznej
      • Elblag, Poland, 82-300
        • Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska
      • Gdansk, Poland, 80-382
        • Synexus Polska Sp. z o.o.
      • Grodzisk Mazowiecki, Poland, 05-825
        • Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
      • Katowice, Poland, 40-611
        • Provita Sp zoo
      • Krakow, Poland, 30-363
        • Centrum Medyczne Plejady
      • Krakow, Poland, 31-624
        • Malopolskie Centrum Alergologii
      • Krakow, Poland, 30-033
        • Centrum Medyczne "All-Med" Badania Kliniczne
      • Lodz, Poland, 92-213
        • Uniwersytet Medyczny w Łodzi - Centrum Wsparcia Badań Klinicznych
      • Lublin, Poland, 20-362
        • Velocity Nova Sp. z o.o.
      • Lublin, Poland, 20-607
        • DERMEDIC Iwona Zdybska
      • Lublin, Poland, 20-412
        • Pro Life Medica ETG Lublin
      • Lublin, Poland, 20-753
        • Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
      • Nowa Sól, Poland, 67-100
        • Twoja Przychodnia Nowosolskie Centrum Medyczne
      • Opole, Poland, 45-401
        • Uniwersytecki Szpital Kliniczny w Opolu
      • Oświęcim, Poland, 32-600
        • Medicome Sp. z o.o.
      • Poznan, Poland, 60-214
        • Centrum Alergologii Teresa Hofman Sp. z.o.o.
      • Poznan, Poland, 60-309
        • EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium
      • Poznan, Poland, 60-693
        • Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
      • Rzeszów, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
      • Rzeszów, Poland, 35-205
        • EMED Centrum Usług Medycznych Ewa Śmiałek
      • Tarnów, Poland, 33-100
        • ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
      • Warsaw, Poland, 02-677
        • ETG Warszawa
      • Warsaw, Poland, 02-672
        • Synexus Polska Sp. z o.o.
      • Warsaw, Poland, 00-874
        • Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
  • Slovakia
      • Bardejov, Slovakia, 08501
        • MAXDERM s.r.o.
      • Bratislava, Slovakia, 85101
        • Derma therapy spol. s.r.o.
      • Košice, Slovakia, 04022
        • ALERSA, sro
      • Trnava, Slovakia, 91702
        • Fakultna Nemocnica Trnava
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Cadiz, Spain, 11009
        • Hospital Universitari Puerta del Mar
      • Madrid, Spain, 28006
        • Hospital Universitario De La Princesa
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Pamplona, Spain, 31008
        • Clinica Universidad Navarra- Pamplona
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Quirónsalud Madrid
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41012
        • FutureMeds Sevilla
      • Torrejón de Ardoz, Spain, 28850
        • Hospital Universitario de Torrejon
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Valencia, Spain, 46940
        • Hospital de Manises
  • Thailand
      • Bangkok Noi, Thailand, 10700
        • Siriraj Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
      • Khlong Luang, Thailand, 12120
        • Thammasat University Hospital
      • Khon Kaen, Thailand, 40002
        • Khon Kaen University
  • Tunisia
      • Sfax, Tunisia, 3029
        • Hôpital Hédi Chaker
      • Tunis, Tunisia, 1007
        • La Rabta Hospital
      • Tunis, Tunisia, 1008
        • Habib Thameur Hospital
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals, Addenbrooke's Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • High Wycombe, United Kingdom, HP11 2QW
        • Velocity Clinical Research High Wycombe
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • London, United Kingdom, E1 1FR
        • The Royal London Hospital
      • North Finchley, United Kingdom, N12 8BU
        • Velocity Clinical Research, North London - PPDS
      • Oxford, United Kingdom, OX44 9PU
        • Virtual Clinical Trials Centre, The Stables
      • Plymouth, United Kingdom, PL6 5FP
        • University Hospitals Plymouth NHS Trust
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Romford, United Kingdom, RM1 3PJ
        • Velocity Clinical Research - Romford
      • Wakefield, United Kingdom, WF1 4DG
        • Pinderfields Hospital
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • Allervie Clinical Research - Cullman
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona PC
      • Scottsdale, Arizona, United States, 85258
        • Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
      • Scottsdale, Arizona, United States, 85260
        • Center for Dermatology & Plastic Surgery
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research, Inc.
      • Los Angeles, California, United States, 90057
        • LA Universal Research Center, Inc.
      • Los Angeles, California, United States, 90025
        • California Allergy and Asthma Medical Group
      • Los Angeles, California, United States, 90024
        • UCLA Clinical Trials Contracts & Strategic Relations
      • Mission Viejo, California, United States, 92691
        • Allergy and Asthma Associates of Southern Cal
      • Pasadena, California, United States, 91107
        • Huntington Asthma & Allergy Center
      • San Diego, California, United States, 92123
        • University Clinical Trials
      • San Diego, California, United States, 92120
        • WR-MCCR
      • San Diego, California, United States, 92120
        • Apex Clinical Research
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
      • Santa Monica, California, United States, 90404
        • Raffi Tachdjian MD, Inc
    • Colorado
      • Castle Rock, Colorado, United States, 80109
        • Clarity Dermatology, PLLC
      • Colorado Springs, Colorado, United States, 80907
        • Asthma and Allergy Associates
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Driven Research Llc
      • Delray Beach, Florida, United States, 33484
        • Palm Beach Dermatology Group
      • Doral, Florida, United States, 33172
        • Dolphin Medical Research
      • Miami, Florida, United States, 33165
        • South FL Clinical Research LLC
      • Miami, Florida, United States, 33173
        • Dade Florida Clinical Research Center
      • Miami Lakes, Florida, United States, 33014
        • Deluxe Health Center
      • Orlando, Florida, United States, 32807
        • Revival Clinical Research
      • Sanford, Florida, United States, 32771
        • International Clinical Research - FL LLC
      • Tamarac, Florida, United States, 33321
        • D&H Tamarac Research Center, LLC
      • Tampa, Florida, United States, 33613
        • University of South Florida
      • Tampa, Florida, United States, 33615
        • Olympian Clinical Research
      • Tampa, Florida, United States, 33609
        • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
      • Tampa, Florida, United States, 33607
        • Advanced Clinical Research Institute (ACRI) - Florida
      • Tampa, Florida, United States, 33607
        • Deluxe Health Center
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Lane Dermatology Research - Centricity - PPDS
      • Macon, Georgia, United States, 31217
        • Skin Care Physicians of Georgia
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Normal, Illinois, United States, 61761
        • Sneeze Wheeze and Itch Associates LLC
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • University of Kansas Medical Center
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Equity Medical
      • Lexington, Kentucky, United States, 40509
        • Allergy & Asthma Associates
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
    • Maryland
      • Towson, Maryland, United States, 21204
        • Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Caledonia, Michigan, United States, 49316
        • Derm Institute of Western Michigan
      • Clarkston, Michigan, United States, 48346
        • Clarkston Skin Research - Clarkston
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63141
        • Midwest Clinical Research, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists PC
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Hudson-Essex Allergy
      • Paramus, New Jersey, United States, 07652
        • Impact Medical / Circuit Clinical
      • Riverdale, New Jersey, United States, 07457
        • Impact Medical / Circuit Clinical
    • New York
      • New York, New York, United States, 10128
        • OptiSkin Medical
      • New York, New York, United States, 10023
        • Equity Medical LLC
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Optima Research
      • Columbus, Ohio, United States, 43235
        • Optimed Research Ltd - ClinEdge - PPDS
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton Hershey Med Cen
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners LLC
    • Texas
      • El Paso, Texas, United States, 79932
        • Western Sky Medical Research
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc.
      • San Antonio, Texas, United States, 78213
        • Rainey & Finklea San Antonio Dermatology
    • Utah
      • Murray, Utah, United States, 84107
        • Allergy Associates of Utah - Sandy
      • West Valley City, Utah, United States, 84120
        • Kalo Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Males and females, >/= 18 years of age.
  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.

Key Exclusion Criteria:

  1. Women who are pregnant or nursing.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: barzolvolimab 150 mg
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Biological: barzolvolimab
Subcutaneous Administration
Experimental: barzolvolimab 300 mg
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Biological: barzolvolimab
Subcutaneous Administration
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.
Biological: barzolvolimab
Subcutaneous Administration
Biological: Matching placebo
Matching placebo Subcutaneous Administration
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.
Biological: barzolvolimab
Subcutaneous Administration
Biological: Matching placebo
Matching placebo Subcutaneous Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)

Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).

The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
From Day 1 (first dose) to Day 85 (Week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The ISS7 is the itch severity score for 7 days, the scores range from 0 to 21.
From Day 1 (first dose) to Day 85 (Week 12)
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days, the scores range from 0 to 21.
From Day 1 (first dose) to Day 85 (Week 12)
Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)

Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) in participants who did not respond to or did not tolerate omalizumab.

The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12 in participants who did not respond to or did not tolerate omalizumab.
From Day 1 (first dose) to Day 85 (Week 12)
Incidence of Treatment-Emergent Adverse Events
Time Frame: From Day 1 (first dose) to Day 477 (Week 68)
Occurrence of treatment emergent adverse events and serious adverse events during the study.
From Day 1 (first dose) to Day 477 (Week 68)
Percentage of patients with UAS7=0 at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.
From Day 1 (first dose) to Day 85 (Week 12)
Percentage of participants with UAS7 ≤ 6 at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7≤6) at Week 12.
From Day 1 (first dose) to Day 85 (Week 12)
Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)

Proportion of participants with AAS7 > 0 at Day 1 who achieved complete control (AAS7 = 0) at Week 12

Angioedema Activity Score over 7 days [AAS7] describes the effect of angioedema on five categories with 0 being none and 3 being most severe. The final score is calculated by adding together daily scores which can range from 0-15 for 7 days. The resulting maximum score is then 105.
From Day 1 (first dose) to Day 85 (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX0159-13
  • 2024-513210-36-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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