Recruiting

RemibrutinibRemibrutinib in Real-world Clinical Practice

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07358364

Conditions

Chronic Spontaneous Urticaria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Prospective, multi-country, non-interventional study in 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. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

Conditions

Chronic Spontaneous Urticaria

Study ID

NCT07358364

Start date

Feb 2, 2026

Status verified date

Apr, 2026

Completion date

Oct 30, 2031

Anticipated

Primary completion date

Oct 30, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3280 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision 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 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 to switch to remibrutinib treatment as per local label

Primary outcome measure

UCT7 score [ Time Frame: 12 weeks after initiating remibrutinib treatment ]
UAS7 score [ Time Frame: 12 weeks after initiating remibrutinib treatment ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Locations

Cleaver Dermatology

Recruiting

Kirksville, Missouri, United States, 63501

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

Remibrutinib
Non-Interventional Study
Chronic Spontaneous Urticaria
Second-generation H1 antihistamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-04-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.