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.
A total of 150 participants will be randomized in a 2:1 ratio to either the lesigercept or placebo group. The study will proceed with a 12-week treatment period, during which the IP will be administered every 4 weeks for a total of three doses, followed by a 4-week follow-up. In total, participants will be observed for 16 weeks to evaluate efficacy, safety, PK, PD, and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Subcutaneous injection of Lesigercept
Subcutaneous injection of None of active ingredient
Diagnostic & Consultative Centre Ascendent EOOD
Sofia, Sofia, Bulgaria
NOT_YET_RECRUITINGUMHAT "Aleksandrovska"
Sofia, Sofia, Bulgaria
NOT_YET_RECRUITINGMedical Center Hera EOOD
Sofia, Sofia, Bulgaria
NOT_YET_RECRUITINGUMHATEM "N. I. Pirogov"
Sofia, Sofia, Bulgaria
NOT_YET_RECRUITINGChange from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12
Urticaria Activity Score over 7 days- minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Time frame: From first dose to Week 12
Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12
Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Time frame: From first dose to Week 12
Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12
Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
Time frame: From first dose to Week 12
Cumulative number of weeks with an Angioedema Activity Score over 7 days (AAS7)=0 response between baseline and Week 12
Angioedema Activity Score over 7 days (AAS7) - minimum value: 0 / maximum value: 105 - Higher scores indicate higher disease activity (worse outcome).
Time frame: From first dose to Week 12
Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12
Dermatology Life Quality Index(DLQI)- minimum value: 0 / maximum value: 30 - Higher scores indicate greater impairment of quality of life (worse outcome).
Time frame: From first dose to Week 12
Occurrence and severity of adverse events (AEs)
• Safety endpoints will be included but not be limited to: * Occurrence of treatment emergent adverse events during the study * Occurrence of treatment emergent serious adverse events during the study
Time frame: Through study completion, approximately 113days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGAlergologia Plus Sp. z o. o.
Poznan, Greater Poland Voivodeship, Poland
NOT_YET_RECRUITINGCentrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, Poland
NOT_YET_RECRUITINGCentrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
NOT_YET_RECRUITINGAlergo-Med Ośrodek Badań Klinicznych Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, Poland
NOT_YET_RECRUITING...and 20 more locations