Study Design | RHAPSIDO® (remibrutinib)

RHAPSIDO^® (remibrutinib) was studied in the largest phase 3 clinical trial program for an oral CSU treatment^1–3

REMIX-1 and REMIX-2 included over 900 adult patients with moderate to severe disease.¹

925 adult patients with CSU were enrolled in 2 identical phase 3 randomized, multicenter, double-blind, placebo-controlled studies.¹

52-week study design chart with RHAPSIDO and Placebo arms for REMIX-1 and REMIX-2.

Patients were randomized in a 2:1 ratio to receive either RHAPSIDO 25 mg or placebo, respectively, for 24 weeks during the double-blind treatment period and continued in a 28-week open-label treatment period, during which all patients received RHAPSIDO 25 mg BID.¹

Second-generation H1 antihistamines started a minimum of 7 days before randomization through the end of the study. All patients were required to have a Weekly Urticaria Activity Score (UAS7) ≥16 (range 0–42), a Weekly Itch Severity Score (ISS7) ≥6 (range 0–21), and a Weekly Hives Severity Score (HSS7) ≥6 (range 0–21) for 7 days prior to randomization.^1,4,5

Baseline characteristics

Baseline characteristics were well balanced between treatment arms.^1,6

Key inclusion criteria⁴

Key exclusion criteria⁴

Baseline characteristics table for RHAPSIDO and Placebo arms in REMIX-2.

Similar baseline characteristics were seen in REMIX-1. Key subgroups in the clinical trials included CSU duration, angioedema history, CU-Index, prior exposure to anti-IgE biologics, and total IgE level.^4-6

*Percentages may not total 100 because of rounding.⁶
^aBMI is the weight in kilograms divided by the square of the height in meters.⁶
^bHSS7 ranges from 0 to 21, with higher scores indicating greater severity.⁶
^cISS7 ranges from 0 to 21, with higher scores indicating greater severity.⁶
^dUAS7 ranges from 0 to 42, with higher scores indicating greater severity.⁶
^eOf the 88 measurements that were missing in this trial, 65 were missing because the assessment was not performed in China.⁶