This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.
Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).
Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.
Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.
≥80% adherence to antihistamines during screening.
Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.
Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results.
History of malignancy within 5 years (except certain cured skin/cervical cancers) or chronic urticaria with known etiology other than CSU (e.g., inducible urticaria, autoimmune diseases).
Active or high-risk parasitic infections, chronic/recurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity/anaphylaxis to study drugs or related classes.
Parallel
Lesigercept
DrugSubcutaneous injection of Lesigercept
Placebo
DrugSubcutaneous injection of None of active ingredient
Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12
Urticaria Activity Score over 7 days- minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12
Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12
Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Cumulative number of weeks with an Angioedema Activity Score over 7 days (AAS7)=0 response between baseline and Week 12
Angioedema Activity Score over 7 days (AAS7) - minimum value: 0 / maximum value: 105 - Higher scores indicate higher disease activity (worse outcome).
Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12
Dermatology Life Quality Index(DLQI)- minimum value: 0 / maximum value: 30 - Higher scores indicate greater impairment of quality of life (worse outcome).
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