Clinical trial NCT04717310: Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Reistone Biopharma Company Limited
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 645
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Were diagnosed with AD (defined by the Hanifin and Rajka criteria)
  2. 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Hospital Affiliated to AMU (Southwest Hospital)
state: Chongqing
city: Chongqing
country: China
facility: Xinqiao Hospital of AMU
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Nanyang
country: China
facility: Nanyang first people's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan NO.1 Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Wuxi
country: China
facility: The Second People's Hospital of Wuxi
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Hospital of Dermatology
state: Jiangxi
city: Chang chun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Hangzhou
country: China
facility: SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Hwa Mei Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Guangzhou
country: China
facility: Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
city: Hangzhou
country: China
facility: Zhejiang province People's Hospital
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
Study officials:
affiliation: Reistone Pharma
name: Yanhong Cheng
role: STUDY_DIRECTOR
References: