A Randomized, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 454
- 试验地点
- 11
- 主要终点
- The percentage of subjects who achieved at least 75% reduction in Psoriasis Area Severity Index （PASI）score from baseline (PASI 75) and the percentage of subjects with sPGA 0/1 at week 16.
研究概览
简要总结
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.
详细描述
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. The study has 2 parts: first part (randomized double-blind) and second part (open).
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
- •Male or female subjects aged ≥18 years old.
- •Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis.
- •At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥
- •Suitable for systematic therapy assessed by investigators.
- •Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational drug administration.
排除标准
- •Types of psoriasis other than chronic plaque-type psoriasis.
- •Drug-induced psoriasis.
- •Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
- •Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
- •History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
- •Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological,hematological, endocrine and other systems before randomization.
- •History of malignant tumour within 5 years before screening.
- •Previous or current autoimmune diseases.
- •Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.
研究组 & 干预措施
Experimental: AK111 regimen 1
干预措施: AK111 (Drug)
Experimental: AK111 regimen 2
干预措施: AK111 (Drug)
结局指标
主要结局
The percentage of subjects who achieved at least 75% reduction in Psoriasis Area Severity Index （PASI）score from baseline (PASI 75) and the percentage of subjects with sPGA 0/1 at week 16.
时间窗: at week 16
PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving \>= 50%, \>= 75% or \>= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.
次要结局
- The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90).(at week 16)