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New drug remibrutinib tested for chronic hives relief in Real-World study

NCT ID NCT07408219

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 350 people with chronic spontaneous urticaria (hives) who are starting remibrutinib, a new drug. Researchers will survey patients and their doctors to see how well the drug controls symptoms and how satisfied patients are. The goal is to understand real-world effectiveness, not to prove the drug works in a controlled setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remibrutinib
What this could lead to
If successful, this could show that remibrutinib helps control hives and improves quality of life in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is early-stage real-world data, not a definitive test of effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

CSU patients who are prescribed and initiating treatment with remibrutinib or dupilumab, and who are invited to participate following a referral from their HCP.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Healthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria: 1. Have an active medical license and be board certified/board eligible allergist or dermatologist in the US. Nurse practitioners and physician assistant practicing in allergy and dermatology are eligible. 2. Manage CSU patients within their practice. 3. Enrolled in the research network or are referred HCPs who agree to participate. 4. Have the requisite patient population based on study inclusion/exclusion criteria. Patients eligible for inclusion in this study must meet all of the following criteria: 5. ≥ 18 years of age. 6. Diagnosed with CSU by an HCP. 7. Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment. 8. Have access to an electronic device with internet capabilities. 9. Able to read and understand English. 10. Willing and able to provide consent for study participation. Exclusion criteria: Patients will be excluded if they meet any of the following criteria: 1. Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program). 2. Exposure to oral corticosteroid treatment in 14 days prior to consent. 3. Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab. 4. Prior participation in a remibrutinib or dupilumab clinical trial. 5. Cognitive impairment that impacts the patient's ability to participate.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic spontaneous urticaria

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis

    RECRUITING

    East Hanover, New Jersey, 07936, United States

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