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New pill for chronic hives tested in everyday clinics

NCT ID NCT07642557

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 1 time

Summary

This study follows 470 adults with chronic spontaneous urticaria (hives) who are starting remibrutinib, a new drug. Researchers will track how well it controls symptoms and any side effects over two years in real-world clinics. The goal is to see if remibrutinib works as well outside of strict trial settings.

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 effectively controls chronic hives in everyday practice, offering a new treatment option for patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also early in real-world testing, and effectiveness may vary across patients.

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 470 people

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

Started

Aug 2026

Expected to finish

May 2029

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

Patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib

Ages

18 years and older

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: 7.2.1 Inclusion criteria Patients must meet all the following criteria to be eligible for inclusion in this study. 1. Patients with a confirmed diagnosis of primary CSU by the treating physician. 2. Aged at least 18 years on the date of enrollment. 3. Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months. 4. Cohort-specific observational inclusion criteria: 1. Cohort 2: Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. 2. Cohort3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least 3 weeks during treatment history, they will be included in cohort 3. Exclusion Criteria: Patients are excluded if they meet any of the following criteria: 1. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib. 2. Patients within the safety follow-up phase of a previous interventional or non-interventional study. 3. Patients who received remibrutinib at any time in the past. 4. Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study. 5. Patients who are treated with remibrutinib outside of the local label.

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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 Investigative Site

    RECRUITING

    Düren, 52349, Germany

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