Remibrutinib for adults with chronic spontaneous urticaria in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Novartis
  East Hanover, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

  This trial tests a sequencing plan using remibrutinib and omalizumab to see if it helps adults with chronic spontaneous urticaria that isn’t well controlled by second-generation antihistamines.

  Recruiting at 10 sites Phase 3 Novartis · London, Ontario and 9 other locations · NCT07816328

• Remibrutinib in real-world care for Chronic Spontaneous Urticaria in Germany

  This study looks at how well and how safely remibrutinib works for adults with chronic spontaneous urticaria in real clinical practice after doctors decide to switch or escalate treatment.

  Recruiting Novartis · Düren · NCT07642557

• Remibrutinib use in everyday US care for chronic spontaneous urticaria

  This US sub-study will test remibrutinib's real-world safety and effectiveness for adults with chronic spontaneous urticaria who are escalating or switching from second-generation H1 antihistamines.

  Recruiting Novartis · Kirksville, Missouri · NCT07358780

• Remibrutinib use in everyday clinical care for chronic spontaneous urticaria

  This project sees if remibrutinib helps adults with chronic spontaneous urticaria who need higher‑dose second‑generation antihistamines or are switching to remibrutinib.

  Recruiting Novartis · Kirksville, Missouri · NCT07358364

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Remibrutinib for Severe Chronic Pruritus of Unknown Origin in Adults

  We’re testing whether remibrutinib can help adults with severe, unexplained itching that hasn’t gone away with moisturizers.

  Recruiting at 12 sites Phase 3 Novartis · Fremont, California and 11 other locations · NCT07811869

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.