Actively Recruiting
RELIEF: Remibrutinib in Chronic Spontaneous Urticaria Early Real World Effectiveness and Satisfaction Survey
Led by Novartis Pharmaceuticals · Updated on 2026-05-11
350
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world effectiveness and patient-centered outcomes of remibrutinib in adults with chronic spontaneous urticaria (CSU), a condition characterized by spontaneous hives and itching. This prospective, non-interventional study compares patients starting remibrutinib treatment to those starting dupilumab, using validated patient reported outcome tools to measure results. The study is based in the United States and sponsored by Novartis Pharmaceuticals. Participants include adult patients diagnosed with CSU who have been prescribed remibrutinib or dupilumab and are expected to start treatment. The study observes two groups: one receiving remibrutinib and the other dupilumab. The treatments are not administered by the study but are prescribed by healthcare providers as part of routine care. The study does not involve drug administration or placebo controls, focusing instead on real-world outcomes and patient satisfaction. During the study, participants use electronic devices to complete assessments including the Urticaria Control Test (UCT-7) at baseline, week 1, and week 4 to measure symptom control. Treatment satisfaction is measured with the Treatment Satisfaction Questionnaire for Medication (TSQM-9) at baseline and week 4. Researchers will monitor changes in these scores to understand treatment impact and patient satisfaction. The study requires participants to be able to read English and provide consent, with ongoing data collection continuing until the study ends in September 2026.
CONDITIONS
Brief Title
A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthcare providers must have an active medical license and be board certified or eligible allergists, dermatologists, nurse practitioners, or physician assistants practicing allergy or dermatology in the US.
- Providers must manage CSU patients and agree to participate in the study.
- Patients must be 18 years or older.
- Patients must have a diagnosis of chronic spontaneous urticaria by a healthcare provider.
- Patients must have a prescription for remibrutinib or dupilumab and be expected to start treatment.
- Patients must have access to an electronic device with internet.
- Patients must be able to read and understand English.
- Patients must be willing and able to provide consent for participation.
You will not qualify if you...
- Patients unable to obtain remibrutinib or dupilumab through samples, commercial means, or assistance programs.
- Patients who used oral corticosteroids within 14 days before consent.
- Patients who used oral corticosteroids within 14 days before starting treatment with remibrutinib or dupilumab.
- Patients who have previously participated in a remibrutinib or dupilumab clinical trial.
- Patients with cognitive impairment that affects their ability to participate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 4 weeks
Participants who are prescribed and initiating treatment with remibrutinib or dupilumab are observed to assess treatment effectiveness and satisfaction.
Baseline visit and follow-up visits at Week 1 and Week 4
Trial Site Locations
Total: 1 location
1
Novartis
East Hanover, New Jersey, United States, 07936
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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