Spontaneous Urticaria Clinical Study (18yrs+)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)

Study Description

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 participatns receive barzolvolimab follwed by a 16-week treatment free period.

Brief 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.

Condition or Disease

Chronic Spontaneous Urticaria

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	915
Primary Outcome Measures	1. Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Actual Study Start Date:	July 2024
Estimated Primary Completion Date:	July 2027

Eligibility Criteria

Ages Eligible for Study:	18 & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Chronic Spontaneous Urticaria

Inclusion Criteria

Males and females, >/= 18 years of age
Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1)
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
f. Willing and able to complete a daily symptom electronic diary and comply with study visits.
g. Participants with and without prior biologic experience are eligible

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
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
History of anaphylaxis
Prior treatment with barzolvolimab

ADDITIONAL DETAILS

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Chronic Spontaneous Urticaria Study (18 Years+)