A Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients With Mild-to-Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 645
- 试验地点
- 31
- 主要终点
- Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8
研究概览
简要总结
This is a Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients with Mild-to-Moderate Atopic Dermatitis.
It will consist of phase II and phase III parts, phase II will be a dose-ranging part and phase III will be a pivotal study part.
详细描述
This study will evaluate the topical SHR0302 ointment, a JAK (Janus Kinase) inhibitor, in atopic dermatitis patients. The EASI (Eczema Area and Severity Index), IGA (immunoglobulin A), SCORAD (Scoring of Atopic Dermatitis),DLQI (Dermatology Life Quality Index)and NRS (Numeric Rating Score) will be applied to assesses to the efficacy, and other safety measurements will be also collected within the whole study duration.
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
- •Male or female subject at least at ≥18 and ≤75years of age at time of informed consent.
- •Have mild-to- moderate AD (Atopic Dermatitis), as determined by all of the following:
- •Were diagnosed with AD (defined by the Hanifin and Rajka criteria)
- •With AD history at least 6 months
- •Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study
- •All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from signing of informed consent, throughout the duration of the study, and for 28 days after last dose of study medication.
排除标准
- •Subjects currently have active forms of other skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with evaluation of the effect of study medication on atopic dermatitis, or skin infections (bacteria, fungi, or viruses), or diseases that can cause skin itching (such as itching caused by diabetes), or subjects who are allergic to topical skin drugs
- •Subjects with serious concomitant illness that could require administering of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g. unstable chronic asthma)
- •Subjects who have a history of mental illness or disease such as anxiety and depression, and are not suitable to participate in this study
- •Subjects with serious and uncontrolled disease that may affect the safety of the subject, compliance, affect the evaluation of the endpoint, or require the use of drugs that are not allowed in the protocol
- •Subjects with Human immunodeficiency virus (HIV), or hepatitis B virus ,or hepatitis C virus ,or syphilis related laboratory test positive (subjects positive for hepatitis B surface antigen, HBV (hepatitis B virus) DNA must be greater than lower limit of detection
- •Subjects with malignant tumors or a history of malignant tumors, except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma
- •Pregnant female subjects, breastfeeding female subjects, or male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in protocol for the duration of the study and for at least 28 days after last dose of investigational product.
- •The investigators determined that there were conditions that affected the safety and efficacy of the investigational drug
- •Subjects who, in the opinion of the investigator or Reistone, will be unsuitable for inclusion in the study.
研究组 & 干预措施
Active Comparator: SHR0302 Ointment Dose#1
Drug: SHR0302 Ointment Twice a day (BID)
干预措施: SHR0302 Ointment (Drug)
Active Comparator: SHR0302 Ointment Dose#2
Drug: SHR0302 Ointment Twice a day (BID)
干预措施: SHR0302 Ointment (Drug)
Active Comparator: SHR0302 Ointment Dose#3
Drug: SHR0302 Ointment Twice a day (BID)
干预措施: SHR0302 Ointment (Drug)
Placebo Comparator: Placebo
Drug: Vehicle Twice a day (BID)
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8
时间窗: 8 weeks
The percentage of subjects achieving the Investigator's Global Assessment（IGA）of clear (0) or almost clear (1) with a ≥2 points improvement from baseline at Week 8
次要结局
未报告次要终点