A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
Trial Parameters
Brief Summary
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
Eligibility Criteria
Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent * CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation) * Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as: * The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1): * UAS7 score (range, 0-42) ≥ 16, and * ISS7 score (range, 0-21) ≥ 6, and * HSS7 score (range, 0-21) ≥ 6 * Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants medical history * Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol * Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7