Image

A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

Comparing Remibrutinib and Dupilumab for chronic hives relief.

Recruiting
18 years and older
All
Phase 3
This study is looking at two medicines, **remibrutinib** and **dupilumab**, for adults with *Chronic Spontaneous Urticaria (CSU)*, a condition causing itchy hives not controlled by *H1-antihistamines*, a common allergy medicine. The study has different parts: a screening period lasting up to 4 weeks, a 12-week treatment period, and an optional 12-week follow-up. During the treatment, participants will take either remibrutinib pills or dupilumab shots, along with their usual H1-antihistamines. **Key Points:** - The **study lasts up to 24 weeks**, including treatment and follow-up. - Participants will need to take medicines **daily and visit the study center regularly**. - There are **screening** and **eligibility requirements**, including age and previous treatments. Participants should not have used remibrutinib or dupilumab before and must be able to keep a daily diary of symptoms. The study checks if these treatments help when H1-antihistamines alone don't work. Participants will be monitored for safety, and if the study medicine becomes available commercially, they may continue using it.
Study details
    Chronic Spontaneous Urticaria (CSU)

NCT06868212

Novartis Pharmaceuticals

2 August 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race
Ethnicity
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.