RecruitingPhase 2NCT07415551

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)

Sponsor

Yuhan Corporation

Enrollment

150 participants

Start Date

Mar 26, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Spontaneous Urticaria (CSU)Allergic Diseases

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lesigercept and a drug called Placebo for people with allergic diseases and chronic spontaneous urticaria (csu). The study is currently recruiting participants at 30 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLesigercept

Subcutaneous injection of Lesigercept

DRUGPlacebo

Subcutaneous injection of None of active ingredient

Locations(30)

Diagnostic & Consultative Centre Ascendent EOOD

Sofia, Sofia, Bulgaria

UMHAT "Aleksandrovska"

Sofia, Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Sofia, Bulgaria

UMHATEM "N. I. Pirogov"

Sofia, Sofia, Bulgaria

Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)

Guangzhou, Guangdong, China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

Alergologia Plus Sp. z o. o.

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne ALL-MED

Krakow, Lesser Poland Voivodeship, Poland

Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland

Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o.

Tarnów, Lesser Poland Voivodeship, Poland

ALL-MED Specjalistyczna Opieka Medyczna

Wroclaw, Lower Silesian Voivodeship, Poland

DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne

Wroclaw, Lower Silesian Voivodeship, Poland

Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny

Lublin, Lublin Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Opolskie Voivodeship, Poland

Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko

Bialystok, Podlaskie Voivodeship, Poland

Bio Zdrowie sp. z o.o.

Bialystok, Podlaskie Voivodeship, Poland

NZOZ GynCentrum Oddział Libero

Katowice, Silesian Voivodeship, Poland

Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)

Katowice, Silesian Voivodeship, Poland

Seoul National University Bundang Hospital

Gyeonggi-do, Bundang-gu, South Korea

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, South Korea

Korea University Ansan Hospital

Gyeonggi-do, Danwon-gu, South Korea

Chung-Ang University Hospital

Seoul, Dongjak-gu, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Inha University Hospital

Incheon, Incheon, South Korea

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, Seocho-gu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seodaemun-gu, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Songpa-gu, South Korea

Ajou University Hospital

Gyeonggi-do, Suwon, South Korea

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NCT07415551

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