Status:
COMPLETED
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Lead Sponsor:
Celldex Therapeutics
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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
Detailed Description
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Spontaneous Urticaria. There is a scre...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- 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.
- Key exclusion criteria:
- Women who are pregnant or nursing.
- Clearly defined cause for chronic urticaria.
- 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.
- 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.
- History of anaphylaxis
- Prior treatment with barzolvolimab
- There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Exclusion
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT05368285
Start Date
May 19 2022
End Date
December 20 2024
Last Update
March 26 2025
Active Locations (56)
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1
Clinical Research Center of Alabama dba Allervie Clinical Research
Birmingham, Alabama, United States, 35249
2
Medical Research of Arizona
Scottsdale, Arizona, United States, 85251
3
Little Rock Allergy & Asthma CRC
Little Rock, Arkansas, United States, 72205
4
Kern Research, Inc
Bakersfield, California, United States, 93301