Early access
Sign in
Active, not recruitingPhase 3

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

Key facts

Who runs it
Celldex Therapeutics
Where
Bakersfield, Baton Rouge, Belleville, Boardman, Boise, Boston, Bowling Green, Caledonia, Castle Rock, Chicago, Clarkston, Colorado Springs, Columbus, Coral Gables, Cullman, Delray Beach, Doral, El Paso, Hershey, Johnston, Kansas City, Lexington, Litchfield Park, Los Angeles, Macon, Miami, Miami Lakes, Mission Viejo, Murray, New York, Normal, Omaha, Orlando, Paramus, Pasadena, Pflugerville, Plainfield, Riverdale, San Antonio, San Diego, Sanford, Santa Monica, Scottsdale, South Bend, St Louis, Tamarac, Tampa, Towson, and West Valley City, United StatesSee the 63 sitesAlso in 21 other countries, 186 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
976 people enrolled
Started
19 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 21 other countries, 186 sites

  • Kern Research, IncBakersfield, United States
  • Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDSBaton Rouge, United States
  • Hudson-Essex AllergyBelleville, United States
  • Optima ResearchBoardman, United States
  • Treasure Valley Medical ResearchBoise, United States
  • Brigham and Women's HospitalBoston, United States
  • Equity MedicalBowling Green, United States
  • Derm Institute of Western MichiganCaledonia, United States
  • Clarity Dermatology, PLLCCastle Rock, United States
  • Rush University Medical CenterChicago, United States
  • Clarkston Skin Research - ClarkstonClarkston, United States
  • Asthma and Allergy AssociatesColorado Springs, United States
  • Lane Dermatology Research - Centricity - PPDSColumbus, United States
  • Optimed Research Ltd - ClinEdge - PPDSColumbus, United States
  • Driven Research LLCCoral Gables, United States
  • AllerVie Clinical Research- CullmanCullman, United States
  • Palm Beach Dermatology GroupDelray Beach, United States
  • Dolphin Medical ResearchDoral, United States
  • Western Sky Medical ResearchEl Paso, United States
  • Penn State Health Milton Hershey Med CenHershey, United States
  • Clinical Partners LLCJohnston, United States
  • University of Kansas Medical CenterKansas City, United States
  • Allergy & Asthma AssociatesLexington, United States
  • Research Solutions of Arizona, PCLitchfield Park, United States
  • California Allergy and Asthma Medical GroupLos Angeles, United States
  • LA Universal Research Center, Inc.Los Angeles, United States
  • UCLA Clinical Trials Contracts & Strategic RelationsLos Angeles, United States
  • Skin Care Physicians of GeorgiaMacon, United States
  • Dade Florida Clinical Research CenterMiami, United States
  • South FL Clinical Research LLCMiami, United States
  • Deluxe Health CenterMiami Lakes, United States
  • Allergy and Asthma Associates of Southern CalMission Viejo, United States
  • Allergy Associates of Utah - SandyMurray, United States
  • Equity Medical LLCNew York, United States
  • OptiSkin MedicalNew York, United States
  • Sneeze Wheeze and Itch Associates LlcNormal, United States
  • Skin Specialists, PCOmaha, United States
  • Revival Clinical ResearchOrlando, United States
  • Impact Medical / Circuit ClinicalParamus, United States
  • Huntington Asthma & Allergy CenterPasadena, United States
  • Austin Institute for Clinical Research, Inc.Pflugerville, United States
  • The Indiana Clinical Trials Center, PCPlainfield, United States
  • Impact Medical / Circuit ClinicalRiverdale, United States
  • Rainey & Finklea San Antonio DermatologySan Antonio, United States
  • Apex Clinical ResearchSan Diego, United States
  • University Clinical TrialsSan Diego, United States
  • WR-MCCRSan Diego, United States
  • International Clinical Research - FL LLCSanford, United States
  • Clinical Science InstituteSanta Monica, United States
  • Raffi Tachdjian MD, Inc.Santa Monica, United States
  • Center for Dermatology & Plastic SurgeryScottsdale, United States
  • Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.Scottsdale, United States
  • South Bend ClinicSouth Bend, United States
  • Midwest Clinical Research LLCSt Louis, United States
  • Washington University School of MedicineSt Louis, United States
  • D&H Tamarac Research Center, LLCTamarac, United States
  • Advanced Clinical Research Institute (ACRI) - FloridaTampa, United States
  • Deluxe Health CenterTampa, United States
  • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical ResearchTampa, United States
  • Olympian Clinical ResearchTampa, United States
  • University of South FloridaTampa, United States
  • Continental Clinical Research Solutions, LLC - ClinEdge - PPDSTowson, United States
  • Kalo Clinical ResearchWest Valley City, 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-CSU2)
Record updated
12 November 2026