Clinical Trial Title
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 TreatmentContact Information
Clinical Trial Protocol Description:
Individuals living with CSU, a condition characterized by persistent and unpredictable hives, face numerous challenges, including mild to extreme itchiness, embarrassment, and a reduced quality of life.
This research study (also known as a clinical trial) is being conducted to assess an investigational study medication (called barzolvolimab) that is administered subcutaneously (i.e., injected under the skin). Researchers are evaluating what effects it has on CSU symptoms, as well as collecting information about how safe it is and how well it’s tolerated by patients at different dose levels compared to placebo
By participating in EMBARQ-CSU, you can play a vital role in advancing medical knowledge and helping us develop more effective therapies. Through rigorous scientific investigation, we aim to alleviate the burden of CSU and hopefully improve the quality of life for those with CSU. EMBARQ-CSU will consist of approximately 19 total clinic visits over about 72 weeks (about 1 year and 5 months). This includes a 2-4-week screening period for the study team to determine if you qualify to participate. During visits, study doctors and staff examine volunteers, perform study related procedures, and ask questions. Participants fill out standardized medical questionnaires and receive the investigational study medication. Visits are scheduled to last two hours or more. Between visits, you will be asked to track your condition using an eDiary, which is an app on your smartphone. If you do not have a smartphone, or do not want to use your smartphone, an eDiary device will be provided at no cost to you.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a confirmed (documented) CSU diagnosis ≥ 6 months prior to Screening
- Have symptoms that have not been adequately controlled with commonly prescribed treatments like antihistamines.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.