A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Key facts
- Who runs it
- Celldex Therapeutics
- Where
- Bakersfield, Birmingham, Boise, Centennial, Chevy Chase, Little Rock, Omaha, Owensboro, Redwood City, Scottsdale, The Bronx, White Marsh, and Ypsilanti, United StatesSee the 13 sitesAlso in 8 other countries, 43 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 208 people enrolled
- Started
- 19 May 2022
- Ended
- 20 Dec 2024
- Type of study
- Interventional, 6 groups
- Treatments tested
- barzolvolimab
- Matching Placebo
- Record updated
- 26 March 2025
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 14 criteriaShow less
Who can take part
- Males and females, >/= 18 years of age
- Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months
- Diagnosis of 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 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 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
Who cannot take part
- Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or 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
- Active, pruritic skin condition in addition to CSU
- Medical condition that would cause additional risk or interfere with study procedures
- Known active HIV, hepatitis B or hepatitis C infection
- History of anaphylaxis
- Women who are pregnant or nursing
- Clearly defined cause for chronic urticaria
Where in United States
Also in 8 other countries, 43 sites
- Kern Research, IncBakersfield, United States
- Clinical Research Center of Alabama dba Allervie Clinical ResearchBirmingham, United States
- Treasure Valley Medical ResearchBoise, United States
- IMMUNOe Research CentersCentennial, United States
- Institute for Asthma and AllergyChevy Chase, United States
- Little Rock Allergy & Asthma CRCLittle Rock, United States
- University of Nebraska Medical CenterOmaha, United States
- Allergy & Asthma Specialists, PSCOwensboro, United States
- Allergy & Asthma ConsultantsRedwood City, United States
- Medical Research of ArizonaScottsdale, United States
- Montefiore Medical Center/Subspeciality-Allergy and ImmunologyThe Bronx, United States
- Chesapeake Clinical ResearchWhite Marsh, United States
- Respiratory Medicine Research Institute of Michigan, PLCYpsilanti, United States
About the trial
What the trial wants to find out
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria
The 6 groups in the trial
- barzolvolimab 75 mg then 150 mgTreatment being tested
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks
Treatment: barzolvolimab
- barzolvolimab 75 mg then 300 mgTreatment being tested
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks
Treatment: barzolvolimab
- barzolvolimab 150 mgTreatment being tested
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks
Treatment: barzolvolimab
- barzolvolimab 300 mgTreatment being tested
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks
Treatment: barzolvolimab
- Placebo then barzolvolimab 150 mgTreatment being tested
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks
Treatment: barzolvolimab and Matching Placebo
- Placebo then barzolvolimab 300 mgTreatment being tested
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks
Treatment: barzolvolimab and Matching Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Spontaneous Urticaria
- Publications
- Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria.The Journal of allergy and clinical immunology, 2026
- Record updated
- 26 March 2025