A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Launched by CELLDEX THERAPEUTICS · Jun 7, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called barzolvolimab for adults suffering from Chronic Spontaneous Urticaria (CSU), which is a condition where people experience itchy hives without a clear cause. The goal of the study is to see if barzolvolimab is effective and safe for those whose symptoms are not well controlled by standard allergy medications. Participants will be compared to a group receiving a placebo, which is a treatment that looks like the drug but doesn’t contain any active ingredients.
To be eligible for this trial, you need to be at least 18 years old and have been diagnosed with CSU for at least six months, despite taking a stable dose of non-sedating allergy medications for at least four weeks before joining the study. Participants will need to keep a daily diary of their symptoms and attend regular study visits. Women who can become pregnant must use effective birth control during and after the study. This trial is currently recruiting participants, so if you or someone you know is interested, talk to your healthcare provider to see if you qualify!
Gender
ALL
Eligibility criteria
- 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.
About Celldex Therapeutics
Celldex Therapeutics is a biopharmaceutical company dedicated to developing innovative therapies for the treatment of cancer and other serious diseases. With a strong focus on immuno-oncology, Celldex harnesses the power of the immune system to create targeted therapies designed to improve patient outcomes. The company's robust pipeline includes a range of novel monoclonal antibodies and antibody-drug conjugates, aimed at addressing unmet medical needs in oncology. Committed to advancing scientific research and clinical development, Celldex Therapeutics collaborates with healthcare professionals and regulatory agencies to bring transformative treatments to patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Barcelona, , Spain
South Bend, Indiana, United States
Utrecht, , Netherlands
Box Hill, Victoria, Australia
Madrid, , Spain
Parkville, Victoria, Australia
Khon Kaen, , Thailand
Melbourne, Victoria, Australia
Madrid, , Spain
Hot Springs, Arkansas, United States
Essen, , Germany
Düsseldorf, , Germany
Münster, , Germany
Bad Bentheim, , Germany
Sevilla, , Spain
Berlin, , Germany
Warren, Michigan, United States
Valencia, , Spain
North Bay, Ontario, Canada
Omaha, Nebraska, United States
Bonn, , Germany
Santa Monica, California, United States
Colorado Springs, Colorado, United States
San Diego, California, United States
Bangkok Noi, , Thailand
Leeds, , United Kingdom
London, , United Kingdom
Plainfield, Indiana, United States
Chiang Mai, , Thailand
Los Angeles, California, United States
Dresden, , Germany
Szolnok, , Hungary
Madrid, , Spain
Dresden, , Germany
Johnston, Rhode Island, United States
Saint Louis, Missouri, United States
San Donato Milanese, , Italy
Glasgow, , United Kingdom
Pflugerville, Texas, United States
Woolloongabba, Queensland, Australia
Doral, Florida, United States
Kraków, , Poland
Rozzano, , Italy
Plymouth, , United Kingdom
Surat, Gujarat, India
Oświęcim, , Poland
Pune, , India
Valencia, , Spain
Boise, Idaho, United States
Gdańsk, , Poland
Genova, , Italy
Dupnitsa, , Bulgaria
Khlong Luang, , Thailand
Salerno, , Italy
Los Angeles, California, United States
Pazardzhik, , Bulgaria
San Diego, California, United States
Bakersfield, California, United States
Pune, Maharashtra, India
Kotara, New South Wales, Australia
Edmonton, Alberta, Canada
Columbus, Ohio, United States
Windsor, Ontario, Canada
New York, New York, United States
Coral Gables, Florida, United States
Nashik, Maharashtra, India
Kansas City, Kansas, United States
Hamilton, Ontario, Canada
West Valley City, Utah, United States
Orlando, Florida, United States
Toronto, Ontario, Canada
Warszawa, , Poland
Sevlievo, , Bulgaria
Coorparoo, Queensland, Australia
Edmonton, Alberta, Canada
Santa Monica, California, United States
Québec, , Canada
Warszawa, , Poland
Sofia, , Bulgaria
East Melbourne, Victoria, Australia
San Diego, California, United States
Tbilisi, , Georgia
Castle Rock, Colorado, United States
Miami Lakes, Florida, United States
Columbus, Georgia, United States
Lublin, , Poland
Scottsdale, Arizona, United States
Baton Rouge, Louisiana, United States
South Jordan, Utah, United States
Norfolk, Virginia, United States
Scottsdale, Arizona, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Overland Park, Kansas, United States
Clarkston, Michigan, United States
Towson, Maryland, United States
Caledonia, Michigan, United States
Richmond Hill, Ontario, Canada
Cullman, Alabama, United States
Litchfield Park, Arizona, United States
Mission Viejo, California, United States
Boca Raton, Florida, United States
Saint Louis, Missouri, United States
Bellaire, Texas, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Coorparoo, Qsl, Australia
Ottawa, Ontario, Canada
Bratislava, , Slovakia
Murray, Utah, United States
Darlinghurst, New South Wales, Australia
Kogarah, New South Wales, Australia
Sydney, New South Wales, Australia
Saskatoon, Saskatchewan, Canada
North Finchley, , United Kingdom
Lo Barnechea, , Chile
Providencia, , Chile
Recoleta, , Chile
Santiago, , Chile
Vitacura, , Chile
Nagpur, Maharashtra, India
Jaipur, Rajasthan, India
Kanpur, Uttar Pradesh, India
Cambridge, , United Kingdom
Tampa, Florida, United States
Haskovo, , Bulgaria
Lovech, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Medellin, , Colombia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Hamburg, , Germany
Lübeck, , Germany
Remscheid, , Germany
Tübingen, , Germany
Vadodara, Gujarat, India
Ahmedabad, , India
Mysore, , India
Milano, , Italy
Kaunas, , Lithuania
Kaunas, , Lithuania
Vilnius, , Lithuania
Roosendaal, , Netherlands
Częstochowa, , Poland
Częstochowa, , Poland
Grodzisk Mazowiecki, , Poland
Kraków, , Poland
Lublin, , Poland
Lublin, , Poland
Poznań, , Poland
Poznań, , Poland
Rzeszów, , Poland
Rzeszów, , Poland
Tarnów, , Poland
Warszawa, , Poland
Bratislava, , Slovakia
Košice, , Slovakia
Cadiz, , Spain
Madrid, , Spain
Pamplona, , Spain
Pontevedra, , Spain
Pozuelo De Alarcón, , Spain
Sevilla, , Spain
Torrejón De Ardoz, , Spain
Riverdale, New Jersey, United States
Sydney, New South Wales, Australia
Edmonton, Alberta, Canada
Medellín, , Colombia
Soledad, , Colombia
Aachen, , Germany
Debrecen, , Hungary
Belgaum, , India
Vadodara, , India
Vilnius, , Lithuania
Amsterdam, , Netherlands
Elbląg, , Poland
Poznań, , Poland
Bardejov, , Slovakia
Oxford, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported