NCT07415551

Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A total of 150 participants will be randomized in a 2:1 ratio to either the lesigercept or placebo group. The study will proceed with a 12-week treatment period, during which the IP will be administered every 4 weeks for a total of three doses, followed by a 4-week follow-up. In total, participants will be observed for 16 weeks to evaluate efficacy, safety, PK, PD, and immunogenicity.

Conditions

• Allergic Diseases
• Chronic Spontaneous Urticaria (CSU)

Interventions

Type	Name	Description
DRUG	Lesigercept	Subcutaneous injection of Lesigercept
DRUG	Placebo	Subcutaneous injection of None of active ingredient

Timeline

• Start date: 2026-03-26
• Primary completion: 2027-06-19
• Completion: 2027-07-24
• First posted: 2026-02-17
• Last updated: 2026-04-15

Locations

30 sites across 4 countries: Bulgaria, China, Poland, South Korea