A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients with Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)

INTERVENTION: Placebo:Placebo;Lesigercept:Lesigercept 150mg;Group 2:Lesigercept 195mg; CONDITION: Chronic Spontaneous Urticaria PRIMARY OUTCOME: the change in UAS7 score from baseline to Week 12; SECONDARY OUTCOME: Proportion of participants achieving well‐controlled urticaria (UAS7=6) at Week 12;Proportion of participants achieving complete control (UAS7=0) at Week 12;Cumulative number of weeks with an AAS7=0 response between baseline and Week 12;Change from baseline in DLQI score at Week 12;Change from baseline in UAS7 in participants naïve to omalizumab at Week 12;Change from baseline in UAS7 in participants refractory to omalizumab at Week 12; INCLUSION CRITERIA: 1.Diagnosis of CSU for at least 6 months prior to screening; 2.Diagnosis of CSU inadequately controlled on 2 nd ‐generation H1‐antihistamines at the time of randomization (Day 1) defined as meeting all of the following: • Presence of itch and hives for > 6 consecutive weeks at any time point prior to screening despite use of 2nd‐generation H1‐antihistamines • Stable dose of 2nd‐generation H1‐antihistamines for at least 7 days prior screening and able to continue on the same H1‐antihistamine maintenance therapy at the daily stable dose during the study • UAS7=16, ISS7=8 (at least 1 point/day) and HSS7=8 (at least 1 point/day), each during the 7 consecutive days prior to randomization Note: UAS7 will be captured once daily at an individual determined adequate time, which must be maintained consistently within ±2 hours throughout the study. Daily symptom diary compliance must be =80%. 3.Participants must meet the criteria for either omalizumab‐naïve or omalizumab