Allergic Diseases, Chronic Spontaneous Urticaria (CSU)
Conditions
Keywords
CSU, YH35324, Allergic disease, Chronic Spontaneous Urticaria, Yuhan, GI-301, Lesigercept, M9010
Brief 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.
Detailed description
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.
Interventions
DRUGLesigercept
Subcutaneous injection of Lesigercept
DRUGPlacebo
Subcutaneous injection of None of active ingredient
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12 | From first dose to Week 12 | Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome) |
| Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12 | From first dose to Week 12 | Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome) |
| Cumulative number of weeks with an Angioedema Activity Score over 7 days (AAS7)=0 response between baseline and Week 12 | From first dose to Week 12 | Angioedema Activity Score over 7 days (AAS7) - minimum value: 0 / maximum value: 105 - Higher scores indicate higher disease activity (worse outcome). |
| Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12 | From first dose to Week 12 | Dermatology Life Quality Index(DLQI)- minimum value: 0 / maximum value: 30 - Higher scores indicate greater impairment of quality of life (worse outcome). |
| Occurrence and severity of adverse events (AEs) | Through study completion, approximately 113days | • 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 |
Countries
Bulgaria, China, Poland, South Korea
Contacts
CONTACTJinHyun Choi
CONTACTJeungJin Yoon
Outcome results
None listed