NCT06380907终止2 期
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical Gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 20
- 主要终点
- Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.
研究概览
简要总结
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis
详细描述
This is a randomized, double-blind, vehicle-controlled, dose-ranging, phase 2 study of ZL-1102 in patients with chronic plaque psoriasis. Approximately 250 patients will be randomized at a ratio of 1:1:1:1:1 to 5 treatment arms for 16 weeks of treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age.
- •Willing and able to provide signed and dated informed consent prior to any study-related procedures, and willing and able to comply with all study procedures
- •Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by Investigator via medical records or in medical history obtained from the patient, is currently eligible for topical treatment and meets all the following criteria at screening and baseline:
- •IGA ≥ 2 (5 score system)
- •Affected BSA 3%-15% (excluding head)
- •Agree not to have prolonged sun exposure (e.g., recreational) during the study period. Tanning bed use or use of other light-emitting diodes (LEDs) is not allowed.
排除标准
- •Other types of psoriasis dominant other than plaque psoriasis (e.g., psoriatic arthritis, pustular, erythrodermic, guttate, palmar, plantar, scalp or nail disease) or the lesion is not eligible for topical treatment only.
- •Patients with any serious medical/psychiatric condition or clinically significant laboratory abnormality that would prevent study participation or place the patient at significant risk, as determined by the Investigator.
- •Known or suspected:
- •Severe renal insufficiency or hepatic insufficiency.
- •History of severe depression or suicidal ideation or behavior within 2 years prior to screening.
- •Positive for any of the following tests at screening:
- •Human immunodeficiency virus (HIV): HIV antibody
- •Hepatitis B virus (HBV): hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb)/HBV DNA
- •Hepatitis C virus (HCV): HCV RNA
- •Patients with active tuberculosis (TB) or untreated latent TB per local guidelines.
- •History of and/or concurrent condition of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn's disease), or signs/symptoms of IBD at screening that, in the opinion of the Investigator, pose an unacceptable risk to the patient if participating in the study.
- •History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to IL-17 antibodies and any human or humanized biological agents.
- •Patients who have a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 3 years before the initiation of study treatment.
- •Patients with a history of chronic alcohol or drug abuse within 6 months of the initiation of study treatment, as determined by the Investigator.
- •Prior exposure to ZL-
- •Patients who have received a live vaccine within 6 weeks prior to dosing on Day
- •Females who are pregnant, wishing to become pregnant during the study, or are breastfeeding
研究组 & 干预措施
Arm 2
Active Comparator
ZL-1102
干预措施: ZL-1102 3% w/w gel BID for 16 weeks (Drug)
Arm 1
Active Comparator
ZL-1102
干预措施: ZL-1102 1% w/w gel BID for 16 weeks (Drug)
Arm 3
Active Comparator
ZL-1102
干预措施: ZL-1102 3% w/w gel QD for 16 weeks (Drug)
Arm 4
Placebo Comparator
Vehicle
干预措施: Placebo ZL-1102 0% w/w gel BID for 16 weeks (Drug)
Arm 5
Placebo Comparator
Vehicle
干预措施: Placebo ZL-1102 0% w/w gel QD for 16 weeks (Drug)
结局指标
主要结局
Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.
时间窗: 16 weeks
The proportion of patients achieving mPASI 75 (at least a 75% reduction in mPASI score from baseline) at Week 16.
次要结局
- Time to achieve IGA score of 0 or 1.(20 Weeks)
- The proportion of patients achieving IGA score of 0 or 1.(20 Weeks)
- The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20.(20 Weeks)
- Mean local tolerability scores (LTS)(20 Weeks)
- Serum concentration of ZL-1102.(16 Weeks)
- Time to achieve 1- or 2-point improvement in IGA.(20 Weeks)
- Anti-drug antibody (ADA) of ZL-1102.(16 Weeks)
- The percent change from baseline in mPASI score.(20 Weeks)
- The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.(20 Weeks)
- The proportion of patients achieving IGA treatment success.(20 Weeks)
- Time to achieve mPASI 50/75/90.(20 Weeks)
- Incidence of Treatment Related Adverse Events through Week 20.(20 Weeks)
研究者
研究点 (20)
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