A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (NCT06445023) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
United States963 participantsStarted 2024-07-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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✓. 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.
Exclusion criteria
✕. Women who are pregnant or nursing.
✕. Chronic urticaria whose predominant manifestation is due to CIndU.
✕. 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.
What they're measuring
1
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Timeframe: From Day 1 (first dose) to Day 85 (Week 12)
✕. Known HIV, hepatitis B or hepatitis C infection.
✕. 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.