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)

Condition studied

Chronic Spontaneous Urticaria

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from baseline in UAS7 at Week12

Endpoint detail

1. Proportion of participants achieving complete control (UAS7=0) at Week 12, 2. Proportion of participants achieving well-controlled urticaria (UAS7≤6) at Week 12, 3. Cumulative number of weeks with an AAS7=0 response between baseline and Week 12, 4. Change from baseline in DLQI score at Week 12, 5. Safety endpoints will be included but not be limited to: - Occurrence of treatment emergent adverse events during the study; - Occurrence of treatment emergent serious adverse events during the study