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)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Bulgaria
Diagnostic & Consultative Centre Ascendent EOOD
NOT_YET_RECRUITING
Sofia
Medical Center Hera EOOD
NOT_YET_RECRUITING
Sofia
UMHAT Aleksandrovska
NOT_YET_RECRUITING
Sofia
UMHATEM N. I. Pirogov
NOT_YET_RECRUITING
Sofia
China
Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)
NOT_YET_RECRUITING
Guangzhou
The University of Hong Kong-Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
Poland
Bio Zdrowie sp. z o.o.
NOT_YET_RECRUITING
Bialystok
Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko