Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12 — From first dose to Week 12
Urticaria Activity Score over 7 days- minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Yuhan Corporation trials in South Korea
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 South Korea