A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Spontaneous Urticaria
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 226
- 主要终点
- Outcome Measure
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor control of second-generation H1 antihistamines.
详细描述
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor control of second-generation H1 antihistamines. A total of 226 patients with chronic spontaneous urticaria (CSU) are planned to be enrolled in this study and randomly assigned to either the experimental group or the control group at a 1:1 ratio. The study consists of a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a continuous treatment period (24 weeks), and a follow-up period (8 weeks).
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥12 and ≤75 years, body weight ≥30 kg, voluntarily sign ICF.
- •Diagnosed with CSU for ≥6 months, with pruritus and wheals for >6 weeks despite using second-generation H1 antihistamines.
- •Within 7 days prior to randomization: UAS7 score ≥16, ISS7 score ≥8, and at least one UAS ≥
- •3.Willing to maintain stable background antihistamine dose during the study (up to 4 times standard dose allowed).
- •4.Agree to use effective contraception during the study and for 6 months after last dose.
排除标准
- •Inducible urticaria (e.g., dermographism, cold, heat, cholinergic) or other chronic pruritic skin diseases (e.g., atopic dermatitis) affecting study assessment.
- •Active tuberculosis, or untreated latent TB; serious active infections.
- •Known or suspected immunodeficiency, or history of invasive opportunistic infections.
- •Known allergy to study drug or excipients.
- •Prior use of MG-K10 or other biologics (anti-IL-4Rα, anti-IgE, etc.) within 16 weeks or 5 half-lives.
- •Use of immunosuppressants, systemic corticosteroids, phototherapy, or Chinese herbal medicine within 4 weeks prior to first UAS assessment.
- •Clinically significant laboratory abnormalities at screening: ANC <1.2×10⁹/L, platelets <90×10⁹/L, ALT/AST/total bilirubin >2×ULN, creatinine >1.5×ULN.
- •Positive for HBsAg, or HBcAb positive with HBV-DNA ≥1×10³ copies/ml; HCV-Ab positive with HCV-RNA positive; HIV antibody positive.
- •QTcF >500 msec or other clinically significant ECG abnormalities.
- •Pregnant, breastfeeding, or planning pregnancy during the study.
- •History of malignant tumors within 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ).
- •Participated in another clinical study and used investigational drug within 12 weeks or 5 half-lives prior to first UAS assessment.
研究组 & 干预措施
MG-K10 humanized monoclonal antibody injection
Usage and dosage: Administer once every 4 weeks, with an initial dose of 600mg (4.0 ml) and subsequent doses of 300mg (2.0 ml)
干预措施: MG-K10 Humanized Monoclonal Antibody Injection (Biological)
placebo
Medication schedule: placebo received on Day 1 (D1) and Week 24 (W24), MG-K10 300mg Q4W received from Week 24 (W24) to Week 48 (W48)
干预措施: Placebo (Biological)
结局指标
主要结局
Outcome Measure
时间窗: 24 weeks
Change from baseline in UAS7 at Week 24
次要结局
- The changes in ISS7 compared(Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56)
- The changes in USA7 compared(Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48, 52, 56)
- Outcome Measure(Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56)
- Proportion of participants with UAS7 ≤6(Weeks 4,8,12,16,20,24,28,32,36,40,44,48,52,56)
- Outcome Measure(Up to 56 weeks)
- DLQI/CDLQI scores change(each visit)