About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Have the requisite patient population based on study inclusion/

Disqualifiers

≥ 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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

350 Participants

are grouped into 2 trial groups

Group A: Remibrutinib Cohort

Group B: Dupilumab Cohort

Trial outcomes

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.

Time frame

Baseline and Week 4

Secondary outcomes

1

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.

Time frame

Baseline and Week 1

2

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.

Time frame

Week 1 and Week 4

3

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.

Time frame

Week 4

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.

Time frame

Baseline and Week 4

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Trial groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts