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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 30
- 主要终点
- Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
- A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.
- Q4W
干预措施: Placebo (Drug)
Lesigercept
- A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.
- Active Dose, Q4W
干预措施: Lesigercept (Drug)
结局指标
主要结局
Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12
时间窗: 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)
Change from baseline in UAS7 at Week 12
时间窗: From first dose to Week 12
次要结局
- Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12(From first dose to Week 12)
- Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12(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(From first dose to Week 12)
- Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12(From first dose to Week 12)
- Occurrence and severity of adverse events (AEs)(Through study completion, approximately 113days)
- Proportion of participants achieving complete control (UAS7=0) at Week 12(From first dose to Week 12)
- Proportion of participants achieving well-controlled urticaria (UAS7≤6) at Week 12(From first dose to Week 12)
- Cumulative number of weeks with an AAS7=0 response between baseline and Week 12(From first dose to Week 12)
- Change from baseline in DLQI score at Week 12(From first dose to Week 12)
- Safety endpoints(Through study completion, approximately 113days)