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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

915 patients around the world
Available in United States, Chile
This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
Celldex Therapeutics
5Research sites
915Patients around the world

This study is for people with

Urticaria
Chronic spontaneous urticaria

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Males and females, >/= 18 years of age.
Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months.
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 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.
Participants with and without prior biologic experience are eligible.
Women who are pregnant or nursing.
Chronic inducible urticaria that would confound the study endpoints.
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.
Known HIV, hepatitis B or hepatitis C infection.
Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
History of anaphylaxis.
Prior treatment with barzolvolimab.

Sites

Clínica Dermacross S.A. - Vitacura - Santiago
Clínica Dermacross S.A. - Vitacura - Santiago
Recruiting
Av. Manquehue Norte 2051 C, Vitacura, Metropolitana, 7640881
Centro Internacional de Estudios Clínicos - CIEC
Centro Internacional de Estudios Clínicos - CIEC
Recruiting
Calle Manzano 343, Oficina 410-411, Comuna de Recoleta, Región Metropolitana, 8420383
BIOCINETIC SpA
Recruiting
Serafín Zamora 190, Torre B, piso 4, Oficina 14. Clínica Vespucio, La Florida
Clínica MEDS
Clínica MEDS
Recruiting
Av. José Alcalde Délano 10581, 7691236 Lo Barnechea, Región Metropolitana, Chile
Clínica de Inmunología y Genética - CIGE
Recruiting
Cl. 54 #46-27, La Candelaria, Medellín, La Candelaria, Medellín, Antioquia, Colombia
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