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A Multi Dose, Phase 2 Study of YH35324 in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Sponsor: Yuhan Corporation
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-03-31
Completion Date
2027-07-24
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Lesigercept
Subcutaneous injection of Lesigercept
Placebo
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