A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients

NCT07408219 | Recruiting

• 1 other identifier: CLOU064AUS05
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic spontaneous urticaria; Remibrutinib; Dupilumab; Urticaria control test; Urticaria control test 7 day recall

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib

  UCT-7 is a validated PRO tool designed to assess disease control over a 7-day recall period. It evaluates symptom burden, quality of life impact, treatment adequacy, and overall disease control. It consists of 4 questions, each of which is scored 0-4, with a total score range of 0-16. A score of \<12 indicates poor disease control, 12-15 = partial control, and 16 indicates complete control.

  Baseline and Week 4

Secondary Outcomes (6)

• Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib

  Baseline and Week 1

• Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and Week 4 in Patients Initiating Remibrutinib

  Week 1 and Week 4

• Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib

  Week 4

• Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib

  Baseline and Week 4

• Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib

  Week 4

Study Arms (2)

Remibrutinib Cohort

Adult patients with CSU who are prescribed and initiating treatment with remibrutinib.

Dupilumab Cohort

Adult patients with CSU who are prescribed and initiating treatment with dupilumab.

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

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

You may qualify if:

• 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.
• Manage CSU patients within their practice.
• Enrolled in the research network or are referred HCPs who agree to participate.

You may not qualify if:

• ≥ 18 years of age.
• Diagnosed with CSU by an HCP.
• Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment.
• Have access to an electronic device with internet capabilities.
• Able to read and understand English.
• Willing and able to provide consent for study participation.
• Patients will be excluded if they meet any of the following criteria:
• Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program).
• Exposure to oral corticosteroid treatment in 14 days prior to consent.
• Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab.
• Prior participation in a remibrutinib or dupilumab clinical trial.
• Cognitive impairment that impacts the patient's ability to participate.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, 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: February 6, 2026
• First Posted: February 13, 2026
• Study Start: January 17, 2026
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)