Living with chronic hives?
Learn about a research study.

This research study is testing an investigational drug for Chronic Spontaneous Urticaria (CSU), sometimes called chronic hives, that may not go away with antihistamines. Study participants could be assigned to receive the investigational drug OR an approved medication called DUPIXENT® (dupilumab). The investigational drug is a pill taken by mouth twice a day and dupilumab is an injection taken every 2 weeks.

During the study, participants will take a stable dose of antihistamines provided by the study doctor.

Hives, also called urticaria, is a skin reaction that causes itchy welts. Chronic hives are welts that last for more than six weeks and return often over months or years. Often, the cause of chronic hives isn't clear.

The welts often start as itchy patches that turn into swollen welts that vary in size. These welts appear and fade at random as the reaction runs its course.

Chronic hives can be very uncomfortable and interfere with sleep and daily activities.¹

Study Overview

We are looking for adults with Chronic Spontaneous Urticaria (CSU) to participate in this research study.

Many people who have CSU continue to experience symptoms despite taking antihistamines like Zyrtec® (cetirizine), Claritin® (loratadine), Allegra® (fexofenadine), or others.

This study is evaluating an investigational drug for people with Chronic Spontaneous Urticaria (CSU) who continue to have symptoms while taking antihistamines. The investigational drug, a pill taken twice a day,  is being compared to DUPIXENT® (dupilumab), an injection given every two weeks, which is already approved by the FDA.

Learn more and complete a short questionnaire to see if you may qualify. 
Take the pre-screening questionnaire.

What is Chronic Spontaneous Urticaria?

CSU is also called chronic hives without a known cause. People who have this condition can get hives, swelling, or both that last for more than 6 weeks.²

Who can join the study?

We are looking for adults diagnosed with Chronic Spontaneous Urticaria (CSU) to participate in this research study.  

If you have CSU and your symptoms don’t go away with your current medications, this study may be an opportunity to explore another option!

You may qualify for this Novartis research study if you: 

  • Are at least 18 years old 

  • Have been diagnosed with Chronic Spontaneous Urticaria (CSU) 

  • Are still having symptoms even after taking antihistamines 

If you pre-qualify, there are other study requirements that the study team will discuss with you. 

Participating in this study is always your choice and you can stop taking part at any time, for any reason.  

What to expect if you join this Novartis study:

  • Meet with a study doctor to see if you meet requirements to participate

  • Attend 7 study visits over 4 months

  • Answering questions about your symptoms in a daily diary

  • You may be reimbursed for reasonable expenses that you may incur as a result of taking part in this study. These expenses may include parking, meals, transportation or other travel-related expenses.

Learn more and complete a short questionnaire to see if you may qualify.
Take the pre-screening questionnaire.

¹ Mayo Clinic: Chronic hives
² American Academy of Dermatology. Hives: Overview

What to expect:

The pre-screening process
If you are interested in joining a research study, the first step is to learn about the study and see if you meet the initial qualifications. All you’ll have to do is fill out the short online pre-screening questionnaire below to see if you may qualify for this study.

If you pass the online pre-screening questionnaire, you'll be connected to a research study site near you. The research study site will reach out to you directly.

Take the pre-screening questionnaire.

Finding a research study site
The study doctor and research team at the study site will provide additional information and guide you through the next steps.

Study sites conducting the study can be found here: ClinicalTrials.gov

You do not have to join the study if you do not want to, and you can change your mind at any time. 

The screening and informed consent process 
If you meet the pre-qualifications, you’ll be invited to the research study site for an in-person visit to learn more about the study.  

At your appointment, the study doctor and research team will explain all the details about the study, including possible risks and what participation involves. They will also answer any questions you may have.  

If you are interested in joining the study after speaking with a study doctor and research team, you will be asked to sign an informed consent document, which confirms you have agreed to participate in the study and go through all the necessary study assessments, which begins with a screening process. The purpose of the screening process is to determine if you meet the study requirements. Based on all the information collected and test results, the doctor will decide if you qualify for the study. 

The study treatment period 
The treatment period for this study will last 12 weeks. During this time, you will receive either an investigational pill taken twice a day or DUPIXENT® (dupilumab), an injection given every two weeks that is already approved by the FDA. You will also take a stable daily dose of an antihistamine, which will be provided by the study doctor.

Study activities and tests will vary at each visit, but may include: 

  • Health-related questions 

  • Routine physical exam 

  • Heart activity check (ECG) 

  • Blood and urine sample collection 

Frequently Asked Questions

  • Clinical research is the process of testing and developing medicines to potentially prevent, treat, or manage diseases. Before any medicine becomes FDA-approved and available, it must undergo clinical trials to ensure safety and effectiveness.

  • The goal of this study is to test how effective the investigational drug is at helping with symptoms of CSU compared to DUPIXENT® (dupilumab).

  • You’ll help us learn about the study drug to see if it could potentially be an option for treating CSU. 

  • Yes. Participating in a study is always your choice. You can change your mind or stop taking part at any time, for any reason. 

  • Here are some useful links to find more important information about this condition: