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Active, not recruitingPhase 3

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

Key facts

Who runs it
Celldex Therapeutics
Where
Ann Arbor, Baltimore, Bexley, Birmingham, Boise, Boynton Beach, Canton, Cincinnati, Clackamas, Cortland, Dallas, Fairborn, Findlay, Fountain Valley, Hialeah, Indianapolis, Inglewood, Las Vegas, Lee's Summit, Lewisville, Los Angeles, Louisville, Margate, Mayfield Heights, Metairie, Miami, Missoula, Murray, New York, North Charleston, Ocean City, Oklahoma City, Owensboro, Oxnard, Philadelphia, Plano, Portland, Redwood City, Rockville, Saint Joseph, San Antonio, San Diego, Sarasota, Skokie, Spokane, St. Petersburg, Toledo, Torrance, Upland, Waco, Wheat Ridge, Wheaton, and Ypsilanti, United StatesSee the 58 sitesAlso in 20 other countries, 177 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
963 people enrolled
Started
11 Jul 2024
Expected to end
Jun 2027
Type of study
Interventional, 4 groups
Treatments tested
  • barzolvolimab
  • Matching placebo
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Prior treatment with barzolvolimab; There are additional criteria that your study doctor will review with you to confirm you are eligible for the study
  • 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
  • History of anaphylaxis
  • Women who are pregnant or nursing
  • Chronic urticaria whose predominant manifestation is due to CIndU

Where in United States

Also in 20 other countries, 177 sites

  • David Fivenson MD Dermatolgy PLLCAnn Arbor, United States
  • Johns Hopkins Asthma and Allergy CenterBaltimore, United States
  • Bexley Dermatology ResearchBexley, United States
  • Cahaba Dermatology Skin Health CenterBirmingham, United States
  • Paradigm Clinical Research BoiseBoise, United States
  • Encore Medical Research Boynton BeachBoynton Beach, United States
  • Apex Clinical ResearchCanton, United States
  • Bernstein Clinical Research Center, LLCCincinnati, United States
  • Portland Allergy and AsthmaClackamas, United States
  • Finger Lakes Medical Research, PLLCCortland, United States
  • Alina clinical trialsDallas, United States
  • Zenos Clinical ResearchDallas, United States
  • Wright State PhysiciansFairborn, United States
  • Auni AllergyFindlay, United States
  • First OC Dermatology - Fountain ValleyFountain Valley, United States
  • Direct Helpers Research CenterHialeah, United States
  • Dawes Fretzin Clinical Research Group-7910 N Shadeland AveIndianapolis, United States
  • 310 Clinical ResearchInglewood, United States
  • Excel Clinical Research - Las VegasLas Vegas, United States
  • Dermatolgy and Skin Cancer CenterLee's Summit, United States
  • Epic Clinical ResearchLewisville, United States
  • Dermatology Research AssociatesLos Angeles, United States
  • Focus Clinical Research - Los AngelesLos Angeles, United States
  • DS Research of Kentucky, LLCLouisville, United States
  • Gsi Clinical ResearchMargate, United States
  • Apex Clinical Research CenterMayfield Heights, United States
  • Clinical Trials Management LLC - Southshore OfficeMetairie, United States
  • International Dermatology Research Inc - MiamiMiami, United States
  • Miami Dade Medical Research Institute, LLCMiami, United States
  • Montana Medical ResearchMissoula, United States
  • University of Utah - MidValley Dermatology - PPDSMurray, United States
  • Sadick Research GroupNew York, United States
  • National Allergy and Asthma Research, LLC - CRN - PPDSNorth Charleston, United States
  • Allergy Partners of N.J., P.C.Ocean City, United States
  • Allergy Asthma and Clinical Research CenterOklahoma City, United States
  • Allergy and Asthma Specialists PSCOwensboro, United States
  • Cura Clinical ResearchOxnard, United States
  • Clinical Research Philadelphia, LLCPhiladelphia, United States
  • VAST Clinical Research - PlanoPlano, United States
  • Oregon Medical Research CenterPortland, United States
  • Allergy and Asthma ConsultantsRedwood City, United States
  • DermAssociates, LLCRockville, United States
  • Medisearch, LLCSaint Joseph, United States
  • STAAMP Research, LLC - CRNSan Antonio, United States
  • Acclaim Clinical ResearchSan Diego, United States
  • Therapeutics Clinical ResearchSan Diego, United States
  • West Dermatology Research CenterSan Diego, United States
  • Sarasota Clinical ResearchSarasota, United States
  • Endeavor HealthSkokie, United States
  • Premier Clinical ResearchSpokane, United States
  • GCP Global Clinical Professionals, LLCSt. Petersburg, United States
  • Toledo Institute of Clinical ResearchToledo, United States
  • Orso Health, Inc.Torrance, United States
  • Integrated Research of Inland, Inc.Upland, United States
  • Allergy and Asthma Care of WacoWaco, United States
  • Western States Clinical Research, Inc.Wheat Ridge, United States
  • Institute for Asthma and AllergyWheaton, United States
  • Resp Medicine Research Institute of MIYpsilanti, United States

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • barzolvolimab 150 mgTreatment being tested

    barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks

    Treatment: barzolvolimab

  • barzolvolimab 300 mgTreatment being tested

    barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks

    Treatment: barzolvolimab

  • Placebo then barzolvolimab 150 mgTreatment being tested

    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.

    Treatment: barzolvolimab and Matching placebo

  • Placebo then barzolvolimab 300 mgTreatment being tested

    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.

    Treatment: barzolvolimab and Matching placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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-CSU1)
Record updated
12 November 2026