Chronic Hives Clinical Study at Advanced ENT & Allergy

If you’re living with chronic hives that continue to affect your daily life, you may be interested in a clinical study at Advanced ENT & Allergy.

Advanced ENT & Allergy is participating in REASSERT, a clinical study evaluating remibrutinib in adults with chronic spontaneous urticaria (CSU) in real-world clinical practice.

The study is sponsored by Novartis, with Kali Gerace, M.D. serving as the Primary Investigator. 

What Is Chronic Spontaneous Urticaria?

Chronic spontaneous urticaria, also called chronic hives or CSU, is a condition that causes recurring hives, itching, and sometimes swelling without a specific external trigger.

For some people, symptoms can continue for months or longer and may interfere with sleep, work, activities, and overall quality of life.

Treatment often begins with antihistamines. However, some people continue to experience symptoms even with treatment, which may lead their physician to consider adjusting or changing their treatment plan.

About the REASSERT Clinical Study

The REASSERT study is designed to learn more about the effectiveness and safety of remibrutinib in people with CSU in everyday clinical practice.

Unlike an interventional clinical trial where the study may determine which treatment a participant receives, REASSERT is a prospective, non-interventional study. This means the decision about a patient's treatment is made by the patient and their treating physician independently of participation in the study.

The study follows patients over time to collect information about their CSU, treatment, symptoms, and overall experience with their condition.

The U.S. study is part of a larger, multi-country REASSERT program designed to collect real-world information about the use of remibrutinib in people with CSU.

What Is Remibrutinib?

Remibrutinib is an oral medication being studied in several immune-mediated conditions, including chronic spontaneous urticaria.

The REASSERT study is evaluating how remibrutinib performs in real-world clinical practice, including its effectiveness and safety in adults with CSU.

Because this is a clinical study, participation does not guarantee that a participant will experience a particular result or benefit.

What Does Participation Involve?

Participants in REASSERT will be followed over time as part of their normal clinical care and study requirements.

The study collects information about factors such as:

• CSU symptoms and disease control
• Treatment history and changes in treatment
• Patient-reported symptoms and quality of life
• Effectiveness of treatment in real-world clinical practice
• Safety and potential side effects

Participants are expected to complete follow-up for up to 24 months.

Some study information is collected through electronic patient-reported outcomes, allowing participants to provide information about their symptoms and experience over time. 

Download the REASSERT Study Information Brochure

Who May Qualify?

The study may be an option for adults who have been diagnosed with chronic spontaneous urticaria.

Key eligibility requirements include:

• Being at least 18 years old
• Having a confirmed diagnosis of primary chronic spontaneous urticaria
• Having CSU that is not adequately controlled with current treatment, depending on the study cohort
• Being willing to provide informed consent
• Being able to complete the required follow-up and electronic study assessments

The study includes different participant groups based on their current treatment and their physician's planned treatment approach.

Additional eligibility requirements apply, and the study team will determine whether you qualify.

Why Participate in a Real-World Clinical Study?

Clinical studies like REASSERT can help researchers better understand how treatments perform in real-world clinical practice.

By collecting information directly from patients and their treating physicians, researchers can learn more about treatment effectiveness, safety, disease control, and the day-to-day experience of people living with chronic spontaneous urticaria.

Participation is voluntary, and the study team will explain the study requirements and answer your questions before you decide whether to participate.

Interested in Learning More?

If you have chronic spontaneous urticaria and would like to learn more about the REASSERT clinical study, the team at Advanced ENT & Allergy can help you understand the study and determine whether you may qualify.

Primary Investigator:
Kali Gerace, M.D.

Study:
REASSERT: Remibrutinib in Real-World Clinical Practice

Sponsor:
Novartis

ClinicalTrials.gov Identifier:
NCT07358780

If you’re interested in learning more, contact Rhonda Dase, Study Coordinator, at (502) 399-1885 x 80071 or rdase@advancedentandallergy.com to discuss the study and whether you may qualify.

Participation in a clinical study is voluntary. Eligibility is determined by the study team based on the study's requirements.