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Clinical Trials in China / NCT07415551
Recruiting Phase 2

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

NCT07415551 · tracked via the Priya Life Science China tracker
Sponsor
Yuhan Corporation
Phase
Phase 2
Started
2026-03-26
Last updated
2026-04-15

Condition(s) studied

Allergic DiseasesChronic Spontaneous Urticaria (CSU)

Investigational drug(s) / intervention(s)

LesigerceptPlacebo

Lesigercept: Subcutaneous injection of Lesigercept

Placebo: Subcutaneous injection of None of active ingredient

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug/alcohol abuse within 6 months.

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Diagnostic & Consultative Centre Ascendent EOOD Sofia Sofia Not Yet Recruiting
UMHAT "Aleksandrovska" Sofia Sofia Not Yet Recruiting
Medical Center Hera EOOD Sofia Sofia Not Yet Recruiting
UMHATEM "N. I. Pirogov" Sofia Sofia Not Yet Recruiting
Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital) Guangzhou Guangdong Not Yet Recruiting
The University of Hong Kong-Shenzhen Hospital Shenzhen Guangdong Not Yet Recruiting
Alergologia Plus Sp. z o. o. Poznan Greater Poland Voivodeship Not Yet Recruiting
Centrum Medyczne ALL-MED Krakow Lesser Poland Voivodeship Not Yet Recruiting
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o. Krakow Lesser Poland Voivodeship Not Yet Recruiting
Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o. Tarnów Lesser Poland Voivodeship Not Yet Recruiting
ALL-MED Specjalistyczna Opieka Medyczna Wroclaw Lower Silesian Voivodeship Not Yet Recruiting
DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne Wroclaw Lower Silesian Voivodeship Not Yet Recruiting
Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny Lublin Lublin Voivodeship Not Yet Recruiting
Uniwersytecki Szpital Kliniczny w Opolu Opole Opolskie Voivodeship Not Yet Recruiting
Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko Bialystok Podlaskie Voivodeship Not Yet Recruiting
Bio Zdrowie sp. z o.o. Bialystok Podlaskie Voivodeship Not Yet Recruiting
NZOZ GynCentrum Oddział Libero Katowice Silesian Voivodeship Not Yet Recruiting
Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita) Katowice Silesian Voivodeship Not Yet Recruiting
Seoul National University Bundang Hospital Gyeonggi-do Bundang-gu Not Yet Recruiting
Keimyung University Dongsan Hospital Daegu Dalseo-gu Recruiting
Korea University Ansan Hospital Gyeonggi-do Danwon-gu Not Yet Recruiting
Chung-Ang University Hospital Seoul Dongjak-gu Recruiting
Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do Not Yet Recruiting
Inha University Hospital Incheon Incheon Not Yet Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea Seoul Seocho-gu Recruiting
Severance Hospital, Yonsei University Health System Seoul Seodaemun-gu Not Yet Recruiting
Kyung Hee University Hospital at Gangdong Seoul Seoul Not Yet Recruiting
Hallym University Kangnam Sacred Heart Hospital Seoul Seoul Not Yet Recruiting
Asan Medical Center Seoul Songpa-gu Not Yet Recruiting
Ajou University Hospital Gyeonggi-do Suwon Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07415551 on ClinicalTrials.gov ↗ ← All trials in China