Remibrutinib in Real-world Clinical Practice - a US Sub-study

NCT07358780 | Recruiting

• 1 other identifier: CLOU064AUS04
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• UAS7 score

  Urticaria Activity Score over 7 days UAS7 is based on 2 daily questions scored 0-3 per day, ranging from 0 (complete control) to 42 (poor control)

  12 weeks after initiating remibrutinib treatment

Secondary Outcomes (32)

• UCT7 score

  12 weeks after initiating remibrutinib treatment

• Number and proportion of participants with well-controlled disease and complete disease

  Up to 24 months

• Change from baseline (CFB) in UCT score

  Up to 24 months

• Change from Baseline in UAS7 score ≥ minimal important difference

  Up to 24 months

• Change in angioedema activity score (AAS7) from baseline

  Up to 24 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Cleaver Dermatology

Kirksville, Missouri, 63501, United States

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)