drugset / Trial / NCT07816328
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU) who are inadequately controlled by second-generation H1-antihistamines (sgH1-AH).
Timeline
- Start
- 2026-09-21
- Primary completion
- 2028-06-02
- Completion
- 2028-06-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 300 mg | — |
| Subject | Remibrutinib | Small molecule | 25 mg | — |