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Chronic urticaria affects approximately 1% of the world's population
.
It occurs in all age groups of men and women, but mainly occurs in young/middle-aged women
Spontaneous chronic urticaria (chronic spontaneous urticaria, CSU) refers to six weeks or more continuous recurrent urticaria, vascular edema, or both
.
About half of CSU patients are accompanied by angioedema, often involving lips, cheeks, periorbital area, limbs and genitals
Blood vessel
Novartis announced on Monday that in the Phase III PEARL 1 and 2 studies of patients with chronic spontaneous urticaria, the experimental drug ligelizumab failed to show an advantage over Xolair (omalizumab)
.
The company said it will further evaluate the data before deciding on the next steps of the plan
These two identical trials started in 2018, and more than 2,000 adult and adolescent patients with chronic spontaneous urticaria were randomly assigned to receive two doses of ligelizumab, Xolair or placebo, and treatment every four weeks for continuous One year
.
The main results of the study examined the change in the urticaria activity score (UAS7) from baseline at week 12
The top-line results showed that although the high-affinity monoclonal anti-IgE antibody ligelizumab achieved better than placebo effects at week 12, it was not as significant as Xolair
.
Novartis said that once the study is completed in the second half of 2022, it will provide complete data on PEARL 1 and 2
The top-line results showed that although the high-affinity monoclonal anti-IgE antibody ligelizumab achieved better than placebo effects at week 12, it was not as significant as Xolair
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