Remibrutinib for adults with chronic spontaneous urticaria in routine care

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

This prospective US study will see if remibrutinib helps adults with chronic spontaneous urticaria in real-world clinical practice using patient-reported outcome questionnaires.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: dupilumab, remibrutinib
• Locations: 1 site (East Hanover, New Jersey)
• Trial ID: NCT07408219 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-interventional, provider-referral study run in the United States that collects real-world outcomes from adults with chronic spontaneous urticaria who are prescribed remibrutinib (and in some cases dupilumab). Participating clinicians refer eligible patients who then complete validated patient-reported outcome (PRO) tools, including the Urticaria Control Test with 7-day recall, via electronic devices. The study captures symptom control and other patient-centered measures during routine care without altering clinical management. Data are aggregated to describe effectiveness and patient experience outside of controlled clinical trials.

Who should consider this trial

Good fit: Adults (≥18) in the US diagnosed with chronic spontaneous urticaria who have a prescription for remibrutinib or dupilumab, can read English, have internet-capable devices, and can give consent are ideal candidates.

Not a fit: People under 18, those not prescribed remibrutinib or dupilumab, non-English speakers, or those without internet access are unlikely to be eligible or benefit from participation in this US-based, PRO-focused study.

Why it matters

Potential benefit: If successful, the study could show whether remibrutinib improves symptom control and quality of life for people with CSU in everyday clinical practice, helping patients and clinicians make more informed treatment choices.

How similar studies have performed: Randomized trials of remibrutinib have reported promising efficacy signals, but real-world observational evidence on patient-reported outcomes for this drug remains limited.

Eligibility criteria

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.

Where this trial is running

East Hanover, New Jersey

• Novartis — East Hanover, New Jersey, United States (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

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