Recruiting

Remibrutinib

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07408219

Conditions

Chronic Spontaneous Urticaria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Chronic Spontaneous Urticaria

Study ID

NCT07408219

Start date

Jan 17, 2026

Status verified date

May, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

Remibrutinib Cohort

Adult patients with CSU who are prescribed and initiating treatment with remibrutinib.

Dupilumab Cohort

Adult patients with CSU who are prescribed and initiating treatment with dupilumab.

Primary outcome measure

  • Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib [ Time Frame: Baseline and Week 4 ]

Central Contacts and Locations

Central contacts

Locations

Novartis

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Chronic spontaneous urticaria
  • Remibrutinib
  • Dupilumab
  • Urticaria control test
  • Urticaria control test 7 day recall

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-05-11.