Dermatology Studies

What is a clinical research study?

A clinical research study is conducted to learn if a new drug, vaccine, booster, treatment, or method is safe and effective. Clinical research studies, also known as clinical trials, follow strict scientific standards and regulations to ensure they produce the best data for health care decision making and to protect the participants.

Why do we need the EMBARQ-CSU study?

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 is why we need groundbreaking research to uncover innovative treatments. 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. Join us in our pursuit of better treatments and together, let us make a difference.

About EMBARQ-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 studyrelated 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.

The EMBARQ-CSU study has three phases:

• A 24-week placebo-controlled treatment phase where volunteers will be placed at random into one of three groups, two of which will receive different doses of the investigational product, the third receiving a placebo, which looks like the study product but does not contain the active ingredient. This means volunteers will have a 66% chance of receiving the investigational medication.
• A 28-week active treatment phase where all participants receive the study medication, meaning those who were previously in the placebo group begin receiving the active investigational medication and those in the other dose groups continue to receive the investigational medication.
• A 16-week follow-up phase where the investigational medication is discontinued, and your condition continues to be monitored.