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

RELIEF: Remibrutinib in Chronic Spontaneous Urticaria: Early Real World Effectiveness and Satisfaction Survey

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Spontaneous Urticaria

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: Novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Recruiting
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria:

Healthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria:

1. 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.
2. Manage CSU patients within their practice.
3. Enrolled in the research network or are referred HCPs who agree to participate.

4. Have the requisite patient population based on study inclusion/exclusion criteria.

   Patients eligible for inclusion in this study must meet all of the following criteria:

5. ≥ 18 years of age.
6. Diagnosed with CSU by an HCP.
7. Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment.
8. Have access to an electronic device with internet capabilities.
9. Able to read and understand English.
10. Willing and able to provide consent for study participation.

Exclusion criteria:

Patients will be excluded if they meet any of the following criteria:

1. Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program).
2. Exposure to oral corticosteroid treatment in 14 days prior to consent.
3. Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab.
4. Prior participation in a remibrutinib or dupilumab clinical trial.
5. Cognitive impairment that impacts the patient's ability to participate.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in UCT-7 Score at Week 1 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 1
Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and 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.	Week 1 and Week 4
Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib	The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.	Week 4
Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib	The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.	Baseline and Week 4
Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib	The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. Scores are produced for each domain, and total scores are calculated and used to assess overall medication satisfaction.	Week 4
Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib	The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. Scores are produced for each domain, and total scores are calculated and used to assess overall medication satisfaction. A positive change from baseline indicates improvement.	Baseline and Week 4

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dupilumab; Chronic spontaneous urticaria; Remibrutinib; Urticaria control test; Urticaria control test 7 day recall
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: CLOU064AUS05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO