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 States, Argentina, Belgium963 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. Active pruritic skin condition in addition to CSU.
. Medical condition that would cause additional risk or interfere with study procedures.
. 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.