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

RecruitingPhase 2Ages 18 Years - 75 YearsAllYuhan Corporation
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Lesigercept
  • Placebo
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Where

30 sites
Diagnostic & Consultative Centre Ascendent EOOD
Sofia, Bulgaria
UMHAT "Aleksandrovska"
Sofia, Bulgaria
Medical Center Hera EOOD
Sofia, Bulgaria
UMHATEM "N. I. Pirogov"
Sofia, Bulgaria
Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)
Guangzhou, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, China
Alergologia Plus Sp. z o. o.
Poznan, Poland
Centrum Medyczne ALL-MED
Krakow, Poland

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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