Actively Recruiting
Phase 2 Study of Lesigercept in Adults with Chronic Spontaneous Urticaria Not Controlled by H1-Antihistamines
Led by Yuhan Corporation · Updated on 2026-04-15
150
Participants Needed
30
Research Sites
5 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of lesigercept in adults with chronic spontaneous urticaria CSU who do not respond adequately to H1-antihistamines, including those previously treated with omalizumab. This phase 2 trial aims to provide evidence on lesigercepts clinical usefulness and better understand its benefit and risk profile in this patient group. About 150 participants will be randomly assigned in a 21 ratio to receive either lesigercept or a placebo. The treatment phase lasts 12 weeks, with lesigercept or placebo given by subcutaneous injection every 4 weeks for a total of three doses. Following treatment, participants will be monitored for an additional 4 weeks. During the 16-week study, participants will have their urticaria activity scores tracked along with safety evaluations, pharmacokinetics, pharmacodynamics, and immune response monitoring. Researchers will assess symptom control, quality of life, and adverse events. The study includes regular symptom diaries, clinical assessments, and laboratory tests to gather comprehensive data on lesigercepts effects.
CONDITIONS
Brief Title
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Research Team
J
JinHyun Choi
J
JeungJin Yoon
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