A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Launched by CELLDEX THERAPEUTICS · May 31, 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 with chronic spontaneous urticaria (CSU), a condition that causes itchy hives that can last for a long time. The goal of the study is to find out if barzolvolimab is effective and safe for people who have not found relief from their symptoms using standard allergy medications called non-sedating antihistamines. The trial will compare the effects of barzolvolimab to a placebo, which is an inactive treatment, to see how well it works.
To be eligible for this study, participants must be at least 18 years old and have been diagnosed with CSU for at least six months, even after using antihistamines for at least four weeks. They must also have had significant symptoms in the week leading up to the study. Both men and women can join, but those who are pregnant or breastfeeding cannot. Participants will keep a daily diary of their symptoms and attend regular study visits. This trial offers a chance to access a new treatment option for those struggling with CSU. Your doctor will go over all the details to ensure you meet the criteria for participation.
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
Gent, , Belgium
Madrid, , Spain
San Diego, California, United States
Baltimore, Maryland, United States
Taichung, , Taiwan
Wheaton, Maryland, United States
Los Angeles, California, United States
Hellerup, , Denmark
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Missoula, Montana, United States
Barcelona, , Spain
Copenhagen Nv, , Denmark
Wheat Ridge, Colorado, United States
Kaohsiung, , Taiwan
Bloemfontein, Free State, South Africa
Brussels, , Belgium
Seongnam Si, , Korea, Republic Of
New York, New York, United States
Toledo, Ohio, United States
München, , Germany
Paris, , France
Kuala Lumpur, , Malaysia
Aarhus N, , Denmark
Ansan, , Korea, Republic Of
Taipei City, , Taiwan
Taipei City, , Taiwan
Kuching, , Malaysia
Miami, Florida, United States
Spokane, Washington, United States
Taoyuan, , Taiwan
Sarasota, Florida, United States
Leuven, Vlaams Brabant, Belgium
George Town, , Malaysia
Johor Bahru, , Malaysia
Kiel, Schleswig Holstein, Germany
Hialeah, Florida, United States
Salamanca, , Spain
Kaohsiung, , Taiwan
Athens, , Greece
Seongnam Si, , Korea, Republic Of
Sofia, , Bulgaria
Fairborn, Ohio, United States
Richmond Hill, Ontario, Canada
San Diego, California, United States
Rockville, Maryland, United States
New Taipei City, , Taiwan
Bexley, Ohio, United States
Córdoba, , Spain
Praha 1, , Czechia
Langenau, , Germany
Hsinchu, , Taiwan
Birmingham, Alabama, United States
Redwood City, California, United States
Markham, Ontario, Canada
San Miguel De Tucuman, Tucuman, Argentina
Auburn Hills, Michigan, United States
Margate, Florida, United States
Athens, , Greece
Tampa, Florida, United States
Waco, Texas, United States
Warsaw, , Poland
Vereeniging, Gauteng, South Africa
Cincinnati, Ohio, United States
Suwon Si, , Korea, Republic Of
Benoni, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Owensboro, Kentucky, United States
Mayfield Heights, Ohio, United States
Toruń, , Poland
Alicante, , Spain
Krugersdorp, Gauteng, South Africa
Maldegem, , Belgium
Milano, , Italy
Katowice, , Poland
Lisboa, , Portugal
Portland, Oregon, United States
Sofia, , Bulgaria
Fountain Valley, California, United States
Upland, California, United States
Saint Petersburg, Florida, United States
Findlay, Ohio, United States
Toronto, Ontario, Canada
Dülmen, Nordrhein Westfalen, Germany
Braga, , Portugal
Skokie, Illinois, United States
Oxnard, California, United States
Indianapolis, Indiana, United States
Metairie, Louisiana, United States
North Charleston, South Carolina, United States
Dallas, Texas, United States
Clarksville, Indiana, United States
Clackamas, Oregon, United States
Plano, Texas, United States
Kielce, , Poland
Louisville, Kentucky, United States
Coral Gables, Florida, United States
Miami, Florida, United States
Ann Arbor, Michigan, United States
Ypsilanti, Michigan, United States
Cortland, New York, United States
Oklahoma City, Oklahoma, United States
Ipoh, , Malaysia
Scottsdale, Arizona, United States
Lee's Summit, Missouri, United States
Cortland, New York, United States
Philadelphia, Pennsylvania, United States
Sofia, , Bulgaria
Boynton Beach, Florida, United States
Saint Joseph, Missouri, United States
Razgrad, , Bulgaria
Stara Zagora, , Bulgaria
Praha 6, , Czechia
Langenau, Baden Württemberg, Germany
Kiel, Schleswig Holstein, Germany
Thessaloníki, , Greece
Katowice, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wrocław, , Poland
Wrocław, , Poland
łódź, , Poland
Madrid, , Spain
Villareal, , Spain
Lisboa, , Portugal
Toronto, Ontario, Canada
Pretoria, Gauteng, South Africa
Ocean City, New Jersey, United States
Buenos Aires, , Argentina
Caba, Ciudad Autonoma De Buenos Aires, Argentina
Caba, Ciudad Autonoma De Buenos Aires, Argentina
Caba, Ciudad Autonoma De Buenos Aires, Argentina
Rosario, Sante Fe, Argentina
Rosario, Sante Fe, Argentina
Rosario, Sante Fe, Argentina
San Miguel De Tucuman, Tucuman, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Brussels, , Belgium
Haskovo, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Yambol, , Bulgaria
Praha 8, , Czechia
Nantes, , France
Nice, , France
Löhne, Niedersachsen, Germany
Bonn, Nordrhein Westfalen, Germany
Attikí, , Greece
Ancona, , Italy
Mantova, , Italy
Torino, , Italy
Verona, , Italy
Bialystok, , Poland
Bydgoszcz, , Poland
Kraków, , Poland
Poznan, , Poland
Skarzysko Kamienna, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Wrocław, , Poland
Newtown, Gauteng, South Africa
Raslouw, Gauteng, South Africa
Durban, Kwa Zulu Natal, South Africa
Mowbray, Western Cape, South Africa
Buenos Aires, , Argentina
Lobos, , Argentina
Buenos Aires, Caba, Argentina
Rosario, Sante Fe, Argentina
Edegem, Antwerpen, Belgium
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Hamilton, Ontario, Canada
Praha 10, , Czechia
Pierre Benite, Rhone, France
La Tronche, , France
Darmstadt, Hesse, Germany
Bramsche, , Germany
Mainz, , Germany
Seongdong, Seoul Teugbyesolsi, Korea, Republic Of
Białystok, , Poland
Gdańsk, , Poland
Poznań, , Poland
Warszawa, , Poland
Aveiro, , Portugal
Coimbra, , Portugal
Matosinhos, , Portugal
Porto, , Portugal
Setúbal, , Portugal
Pretoria, , South Africa
Sabadell, Barcelona, Spain
Taichung City, , Taiwan
Taipei City, , Taiwan
Murray, Utah, United States
Buenos Aires, , Argentina
Brussels, , Belgium
Edmonton, Alberta, Canada
St. John's, Newfoundland And Labrador, Canada
Rouen, , France
Elbląg, , Poland
Vila Nova De Gaia, , Portugal
Buenos Aires, Buenos Aires Province, Argentina
Buenos Aires, Buenos Aires Province, Argentina
Lobos, Buenos Aires Province, Argentina
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported