NCT07408219 · Novartis Pharmaceuticals
A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
(RELIEF)
What this study is about
This is a United States (US) based, forward-looking, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Healthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria:
- 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/
Exclusion criteria
- . Patients eligible for inclusion in this study must meet all of the following criteria:
- ≥ 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. Exclusion criteria: 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.
Where
- East Hanover, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations