This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines
This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebo-controlled study investigating the efficacy, safety and tolerability of six dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. The study comprised of the 7 treatment arms: LOU064 10 mg q.d., LOU064 35 mg q.d., LOU064 100 mg q.d., LOU064 10 mg b.i.d, LOU064 25 mg b.i.d., LOU064 100 mg b.i.d. and placebo.
10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
10mg bid of LOU064 orally, twice daily from Day 1 to 85
25 mg bid of LOU064 orally, twice daily from Day 1 to 85
100 mg bid of LOU064 orally, twice daily from Day 1 to 85
Matching placebo, orally, twice daily from Day 1 to 85
CABA, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Mendoza, Mendoza Province, Argentina
CABA, Argentina