New drug for chronic hives tested in everyday practice
NCT ID NCT07358780
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows about 500 adults with chronic spontaneous urticaria (CSU) who are either starting remibrutinib or sticking with standard antihistamines. Researchers will track how well the drug controls hives and itching over 24 months, and monitor for side effects. The goal is to see if remibrutinib works as well in real-world settings as it does in controlled trials.
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 is a safe and effective option for people with chronic hives that are not controlled by standard antihistamines.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less reliable. Remibrutinib is still new, and long-term risks are not fully known.
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 505 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
-
Sep 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 either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib
- 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 Hide 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: * Patients with a confirmed diagnosis of primary CSU by the treating physician. * Aged at least 18 years on the date of enrolment. * Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months. * Cohort-specific observational inclusion criteria: * Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision (independent of study enrolment) to escalate sgH1-AH treatment. * 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 enrolment) to switch to remibrutinib treatment as per local label. * Cohort 3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrolment) 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 three weeks during treatment history, they will be included in cohort 3. Note: Candidate patients must not have initiated the next escalated treatment step (i.e. up dosed AH for cohort 1, or remibrutinib for cohorts 2 and 3) prior to their enrolment to ensure the baseline visit captures their clinical status before treatment escalation. Exclusion Criteria: * Currently enrolled in a clinical trial or on any experimental treatment. * Patients within the safety follow-up phase of a previous interventional or non-interventional study. * Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or MAP/PSDS at any time in the past. * Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study. * Patients who are treated with remibrutinib outside of the local label.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic spontaneous urticaria are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Cleaver Dermatology
RECRUITINGKirksville, Missouri, 63501, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a diet tame chronic hives in teens?
- Can a new pill silence the itch of chronic hives?
- New drug aims to quiet chronic hives
- New pill for chronic hives enters first human tests
- New pill for chronic hives tested in everyday clinics
- New hope for chronic hive sufferers: phase 3 drug trial shows promise