The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods: * Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility. * Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks. * Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.
Liquid in vial
Lyophilized powder for solution in vial
Liquid in vial
CABA, Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
Ciudad Autonoma de Bs As, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Buenos Aires, Nueve De Julio, Argentina
Bahía Blanca, Argentina
Buenos Aires, Argentina
Capital Federal, Argentina