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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Allergic Diseases, Chronic Spontaneous Urticaria (CSU)

In brief

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.

Key facts

Study ID

NCT07415551

Run by

Yuhan Corporation

People needed

150

Starts

2026-03-26

Expected to finish

2027-07-24

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul, Seocho-gu, South Korea (enrolling)
• Keimyung University Dongsan Hospital — Daegu, Dalseo-gu, South Korea (enrolling)
• Chung-Ang University Hospital — Seoul, Dongjak-gu, South Korea (enrolling)
• 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
• Korea University Ansan Hospital — Gyeonggi-do, Danwon-gu, South Korea
• Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea
• Inha University Hospital — Incheon, Incheon, 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

Full record on ClinicalTrials.gov

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