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AzTrials

Chronic Spontaneous UrticariaPhase 3EMBARQ-CSU2NCT06455202

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

A Phase 3 study testing barzolvolimab in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 245 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
barzolvolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
976 participants
Where
245 sitesin 22 countries
Study dates
19 Jul 2024to Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Women who are pregnant or nursing.
  • Chronic urticaria whose predominant manifestation is due to CIndU.
  • Other diseases associated with urticaria.
  • Active pruritic skin condition in addition to CSU.
  • Medical condition that would cause additional risk or interfere with study procedures.
  • Known HIV, hepatitis B or hepatitis C infection.
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  • 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.
  • History of anaphylaxis
  • Prior treatment with barzolvolimab
  • There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Trial locations and contacts

245 sites in 22 countries.

245 sites in 22 countries

United States63 sites

  • Kern Research, Inc.

    Bakersfield, California, 93301

  • Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS

    Baton Rouge, Louisiana, 70808

  • Hudson-Essex Allergy

    Belleville, New Jersey, 07109

  • Optima Research

    Boardman, Ohio, 44512

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Equity Medical

    Bowling Green, Kentucky, 42104

  • Derm Institute of Western Michigan

    Caledonia, Michigan, 49316

  • Clarity Dermatology, PLLC

    Castle Rock, Colorado, 80109

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Clarkston Skin Research - Clarkston

    Clarkston, Michigan, 48346

  • Asthma and Allergy Associates

    Colorado Springs, Colorado, 80907

  • Lane Dermatology Research - Centricity - PPDS

    Columbus, Georgia, 31904

  • Optimed Research Ltd - ClinEdge - PPDS

    Columbus, Ohio, 43235

  • Driven Research LLC

    Coral Gables, Florida, 33134

  • Allervie Clinical Research - Cullman

    Cullman, Alabama, 35058

  • Palm Beach Dermatology Group

    Delray Beach, Florida, 33484

  • Dolphin Medical Research

    Doral, Florida, 33172

  • Western Sky Medical Research

    El Paso, Texas, 79932

  • Penn State Health Milton Hershey Med Cen

    Hershey, Pennsylvania, 17033

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-8500

  • Allergy & Asthma Associates

    Lexington, Kentucky, 40509

  • Research Solutions of Arizona PC

    Litchfield Park, Arizona, 85340

  • UCLA Clinical Trials Contracts & Strategic Relations

    Los Angeles, California, 90024

  • California Allergy and Asthma Medical Group

    Los Angeles, California, 90025

  • LA Universal Research Center, Inc.

    Los Angeles, California, 90057

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217

  • South FL Clinical Research LLC

    Miami, Florida, 33165

  • Dade Florida Clinical Research Center

    Miami, Florida, 33173

  • Deluxe Health Center

    Miami Lakes, Florida, 33014

  • Allergy and Asthma Associates of Southern Cal

    Mission Viejo, California, 92691

  • Allergy Associates of Utah - Sandy

    Murray, Utah, 84107

  • Equity Medical LLC

    New York, New York, 10023

  • OptiSkin Medical

    New York, New York, 10128

  • Sneeze Wheeze and Itch Associates LLC

    Normal, Illinois, 61761

  • Skin Specialists PC

    Omaha, Nebraska, 68144

  • Revival Clinical Research

    Orlando, Florida, 32807

  • Impact Medical / Circuit Clinical

    Paramus, New Jersey, 07652

  • Huntington Asthma & Allergy Center

    Pasadena, California, 91107

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas, 78660

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

  • Impact Medical / Circuit Clinical

    Riverdale, New Jersey, 07457

  • Rainey & Finklea San Antonio Dermatology

    San Antonio, Texas, 78213

  • Apex Clinical Research

    San Diego, California, 92120

  • WR-MCCR

    San Diego, California, 92120

  • University Clinical Trials

    San Diego, California, 92123

  • International Clinical Research - FL LLC

    Sanford, Florida, 32771

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Raffi Tachdjian MD, Inc

    Santa Monica, California, 90404

  • Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.

    Scottsdale, Arizona, 85258

  • Center for Dermatology & Plastic Surgery

    Scottsdale, Arizona, 85260

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Midwest Clinical Research, LLC

    St Louis, Missouri, 63141

  • Washington University School of Medicine

    St Louis, Missouri, 63141

  • D&H Tamarac Research Center, LLC

    Tamarac, Florida, 33321

  • Advanced Clinical Research Institute (ACRI) - Florida

    Tampa, Florida, 33607

  • Deluxe Health Center

    Tampa, Florida, 33607

  • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

    Tampa, Florida, 33609

  • University of South Florida

    Tampa, Florida, 33613

  • Olympian Clinical Research

    Tampa, Florida, 33615

  • Continental Clinical Research Solutions, LLC - ClinEdge - PPDS

    Towson, Maryland, 21204

  • Kalo Clinical Research

    West Valley City, Utah, 84120

Other trials in United States

Poland26 sites

  • Klinika Dermatologii i Dermatologii Onkologicznej

    Częstochowa, 42-202

  • Centrum Medyczne Pratia Częstochowa

    Częstochowa, 42-217

  • Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska

    Elblag, 82-300

  • Synexus Polska Sp. z o.o.

    Gdansk, 80-382

  • Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK

    Grodzisk Mazowiecki, 05-825

  • Provita Sp zoo

    Katowice, 40-611

  • Centrum Medyczne "All-Med" Badania Kliniczne

    Krakow, 30-033

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Malopolskie Centrum Alergologii

    Krakow, 31-624

  • Uniwersytet Medyczny w Łodzi - Centrum Wsparcia Badań Klinicznych

    Lodz, 92-213

  • Velocity Nova Sp. z o.o.

    Lublin, 20-362

  • Pro Life Medica ETG Lublin

    Lublin, 20-412

  • DERMEDIC Iwona Zdybska

    Lublin, 20-607

  • LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska

    Lublin, 20-753

  • Twoja Przychodnia Nowosolskie Centrum Medyczne

    Nowa Sól, 67-100

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45-401

  • Medicome Sp. Z O.O.

    Oświęcim, 32-600

  • Centrum Alergologii Teresa Hofman Sp. z.o.o.

    Poznan, 60-214

  • EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium

    Poznan, 60-309

  • Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen

    Poznan, 60-693

  • Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej

    Rzeszów, 35-055

  • EMED Centrum Usług Medycznych Ewa Śmiałek

    Rzeszów, 35-205

  • ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.

    Tarnów, 33-100

  • Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa

    Warsaw, 00-874

  • Synexus Polska Sp. z o.o.

    Warsaw, 02-672

  • ETG Warszawa

    Warsaw, 02-677

Other trials in Poland

India15 sites

  • Panchshil Hospital - Ahmedabad

    Ahmedabad, 380005

  • B. J. Medical College and Civil Hospital

    Ahmedabad, 380016

  • KLES Dr Prabhakar Kore Hospital & Medical Research Centre

    Belagavi, 590010

  • All India Institute of Medical Sciences

    Bhubaneswar, 751019

  • Excelcare Hospital

    Jaipur, Rajasthan, 302012

  • Apex Hospitals Pvt Ltd

    Jaipur, 302017

  • G.S.V.M. Medical College - Kanpur

    Kanpur, Uttar Pradesh, 208002

  • K R Hospital

    Mysore, 570001

  • Shree Hospital & Critical Care Centre

    Nagpur, Maharashtra, 440009

  • Assured Care Plus Hospital

    Nashik, Maharashtra, 422101

  • Oyster & Pearl Hospitals

    Pune, Maharashtra, 411005

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004

  • Nirmal Hospital PVT LTD

    Surat, Gujarat, 395002

  • Medical College Baroda & SSG Hospital

    Vadodara, Gujarat, 390001

  • Sumandeep Vidyapeeth University - Dhiraj Hospital

    Vadodara, 391760

Other trials in India

Canada13 sites

  • Laser Rejuvenation Clinics Edmonton D.T. Inc.

    Edmonton, Alberta, T5J 3S9

  • Vida Clinical Research

    Edmonton, Alberta, T6H 4J8

  • Rejuvenation Dermatology Edmonton South

    Edmonton, Alberta, T6W 0J5

  • LEADER research

    Hamilton, Ontario, L8L 3C3

  • Kingston Health Science Center

    Kingston, K7L 2V7

  • DermEffects

    London, Ontario, N6H 5L5

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 3Z7

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario, K1H1E4

  • Centre de Recherche Saint-Louis (Québec)

    Québec, G1W4R4

  • York Dermatology Clinic & Research Centre

    Richmond Hill, Ontario, L4B 1L1

  • Saskatoon Dermatology Centre

    Saskatoon, Saskatchewan, S7T0G3

  • North York Research Inc.

    Toronto, Ontario, M2N 3A6

  • Joel Liem Medicine Professional Corporation

    Windsor, Ontario, N8X 2G1

Other trials in Canada

Germany13 sites

  • Universitätsklinikum der RWTH Aachen Hautklinik

    Aachen, 52074

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Emovis GmbH

    Berlin, 10629

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Essen

    Essen, 45147

  • Eurofins bioskin Research Center Dermalology

    Hamburg, 20095

  • UKSH Lübeck, Institut für Entzündungsmedizin

    Lübeck, 23538

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Universitätsklinikum Münster

    Münster, 48149

  • Hautarztpraxis Dariusch Mortazawi

    Remscheid, 42897

  • Universitäts-Hautklinik, Studienzentrum Immundermatologie

    Tübingen, 72076

Other trials in Germany

United Kingdom13 sites

  • Southmead Hospital

    Bristol, BS10 5NB

  • Cambridge University Hospitals, Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Velocity Clinical Research High Wycombe

    High Wycombe, HP11 2QW

  • St James's University Hospital

    Leeds, LS9 7TF

  • The Royal London Hospital

    London, E1 1FR

  • Velocity Clinical Research, North London - PPDS

    North Finchley, N12 8BU

  • Virtual Clinical Trials Centre, The Stables

    Oxford, OX44 9PU

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 5FP

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Velocity Clinical Research - Romford

    Romford, RM1 3PJ

  • Pinderfields Hospital

    Wakefield, WF1 4DG

Other trials in United Kingdom

Bulgaria12 sites

  • Medical Centre Asklepii OOD

    Dupnitsa, 2600

  • Medical Center - Pulmo 2018

    Haskovo, 6300

  • Medical Center Medconsult Pleven

    Lovech, 5500

  • Multiprofile Hospital for Active Treatment - Pazardzhik AD

    Pazardzhik, 4400

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4002

  • Medical Center Prolet

    Rousse, 7000

  • Medical Center Unimed EOOD

    Sevlievo, 5400

  • Diagnostic-consultative center Ascendent EOOD

    Sofia, 1202

  • Diagnostic and Consultative Center Aleksandrovska EOOD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"

    Sofia, 1527

  • Diagnostic-Consultative Centre Convex EOOD

    Sofia, 1680

Other trials in Bulgaria

Mexico12 sites

  • Unidad de Investigación Cima S.a

    Chihuahua City, 31200

  • Meidadvance Clinical

    Chihuahua City, 31203

  • Cryptex

    Cuauhtémoc, 06100

  • Centro de Investigación Medico Biologica

    Guadalajara, 44130

  • CIMET

    Guadalajara, 44340

  • Panamerican Guadalajara

    Guadalajara, 44670

  • Centro de Desarrollo Biomédico

    Mérida, 97000

  • Mérida Investigación Clínica

    Mérida, 97125

  • Eukarya Pharmasite

    Monterrey, 64718

  • CECYPE

    Morelia, 58249

  • Unidad de Medicina Especializada

    San Juan del Río, 76800

  • FAICIC

    Veracruz, 91900

Other trials in Mexico

Australia11 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Novatrials

    Charlestown, New South Wales, 2290

  • Cornerstone Dermatology

    Coorparoo, Queensland, 4151

  • Skin and Cancer Foundation - The Skin Hospital

    Darlinghurst, New South Wales, 2010

  • Dr Rodney Sinclair Pty Ltd

    East Melbourne, Victoria, 3002

  • St George Dermatology and Skin Cancer Center

    Kogarah, New South Wales, 2217

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain11 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Puerta del Mar

    Cadiz, 11009

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital 12 De Octubre

    Madrid, 28041

  • Clinica Universidad Navarra- Pamplona

    Pamplona, 31008

  • Hospital Quironsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital universitario Virgen Macarena

    Seville, 41009

  • FutureMeds Sevilla

    Seville, 41012

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, 28850

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital de Manises

    Valencia, 46940

Other trials in Spain

Chile8 sites

  • Clinica MEDS La Dehesa

    Lo Barnechea, 7691236

  • Hospital Base San Jose de Osorno

    Osorno, 5290000

  • Enroll SpA - Dr. Manuel Barros Borgono

    Providencia, 7500000

  • Clinica Davila - Recoleta

    Recoleta, 8420000

  • Centro Internacional de Estudios Clinicos (CIEC)

    Recoleta, 8420383

  • BIOCINETIC Ltda

    Santiago, 8350595

  • Medical Skin Center

    Viña del Mar, 2520000

  • Dermacross Clinica Dermatologica

    Vitacura, 7630000

Other trials in Chile

New Zealand8 sites

  • Optimal Clinical Trials - Central

    Auckland, 1010

  • Pcrn Chch

    Christchurch, 8013

  • Momentum Clinical Research Dunedin

    Dunedin, 9016

  • Lakeland Clinical Trials - Waikato

    Hamilton, 3200

  • velocity Nova Sp. z o.o.

    Nelson, 7011

  • Pacific Clinical Research Network Rotorua

    Rotorua, 3010

  • Momentum Clinical Research Tauranga

    Tauranga, 3110

  • Lakeland Clinical Trials Wellington

    Upper Hutt, 5018

Other trials in New Zealand

Italy7 sites

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Asst Fbf Sacco

    Milan, 20157

  • Azienda Ospedale Università di Padova

    Padova, 38068

  • Humanitas Research Hospital

    Rozzano, 20089

  • AOU San Giovanni di Dio e Ruggi d'Aragona

    Salerno, 84131

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

  • Ospedale San Lazzaro PO Molinette

    Torino, 10126

Other trials in Italy

Colombia6 sites

  • Centro Integral de Reumatologia Del Caribe

    Barranquilla, 8001

  • Hospital Alma Mater de Antioquia

    Medellín, 50010

  • Centro de Inmunología y Genética - CIGE S.A.S

    Medellín, 50012

  • Hospital General de Medellín Luz Castro de Gutiérrez

    Medellín, 50015

  • Fundación Centro de Investigation Clínica CIC

    Medellín, 50021

  • Fundación Hospital Universidad del Norte

    Soledad, 83001

Other trials in Colombia

Georgia4 sites

  • LTD" Healthy Future"

    Tbilisi, 0119

  • LTD "Center of Allergy and Immunology"

    Tbilisi, 0159

  • David Abuladze Georgian Italian Clinic

    Tbilisi, 0179

  • LTD "Multiprofile Clinic Consilium Medulla"

    Tbilisi, 0186

Other trials in Georgia

Lithuania4 sites

  • CD8 Klinika

    Kaunas, LT-44192

  • UAB Ausros Medicinos Centras

    Kaunas, LT-49387

  • UAB "Alerginių susirgimų diagnostikos ir gydymo centras"

    Vilnius, LT-08109

  • Santaros KTC (klinikiniu tyrimu centras)

    Vilnius, LT-08406

Other trials in Lithuania

Slovakia4 sites

  • MAXDERM s.r.o.

    Bardejov, 08501

  • Derma therapy spol. s.r.o.

    Bratislava, 85101

  • ALERSA, sro

    Košice, 04022

  • Fakultna nemocnica Trnava

    Trnava, 91702

Other trials in Slovakia

Thailand4 sites

  • Siriraj Hospital

    Bangkok Noi, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Thammasat University Hospital

    Khlong Luang, 12120

  • Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

Hungary3 sites

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, 4032

  • Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

  • Allergo-Derm Bakos Kft.

    Szolnok, 5000

Other trials in Hungary

Netherlands3 sites

  • AmdsterdamUMC locatie AMC

    Amsterdam, 1105 AZ

  • Bravis Hospital

    Roosendaal, 4708 AE

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Tunisia3 sites

  • Hôpital Hédi Chaker

    Sfax, 3029

  • La Rabta Hospital

    Tunis, 1007

  • Habib Thameur Hospital

    Tunis, 1008

Other trials in Tunisia

Croatia2 sites

  • Special Hospital Medico

    Rijeka, 51000

  • Solmed Clinic

    Zagreb, 10000

Other trials in Croatia

About this study

Official title: 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.

Read the 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.

Being tested
barzolvolimab, Matching placebo
Keywords
CDX-0159, barzolvolimab, chronic spontaneous urticaria, CSU, urticaria activity score, itch severity score, hives severity score
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • barzolvolimabBiological

    Subcutaneous Administration

  • Matching placeboBiological

    Matching placebo Subcutaneous Administration

Study groups in NCT06455202
Study groupRoleWhat they receive
barzolvolimab 150 mgExperimentalbarzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Receives: Biological: barzolvolimab
barzolvolimab 300 mgExperimentalbarzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Receives: Biological: barzolvolimab
Placebo then barzolvolimab 150 mgExperimentalPlacebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
Receives: Biological: barzolvolimab; Biological: Matching placebo
Placebo then barzolvolimab 300 mgExperimentalPlacebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
Receives: Biological: barzolvolimab; Biological: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

    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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

Secondary outcomes (8)

  1. Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)

    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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  2. Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)

    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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  3. Percentage of patients with UAS7=0 at Week 12

    Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  4. Percentage of participants with UAS7 ≤ 6 at Week 12

    Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7≤6) at Week 12.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  5. Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at 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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  6. Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at 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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  7. Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at 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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  8. Incidence of Treatment-Emergent Adverse Events

    Occurrence of treatment emergent adverse events and serious adverse events during the study.

    Measured: From Day 1 (first dose) to Day 477 (Week 68)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start19 Jul 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
976 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455202
Sponsor's protocol ID
CDX0159-13
Other IDs
2024-513210-36-00
Acronym
EMBARQ-CSU2
Status last verified
Mar 2026
First submitted
7 Jun 2024
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing barzolvolimab in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 245 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 245 sites in United States, Poland, India, Canada, Germany and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (time frame: From Day 1 (first dose) to Day 85 (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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