Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis

NCT ID: NCT04717310

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 645 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2024-07-14

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Comparator: SHR0302 Ointment Dose#1

Drug: SHR0302 Ointment Twice a day (BID)

Group Type: ACTIVE_COMPARATOR

SHR0302 Ointment

Intervention Type: DRUG

SHR0302 Ointment Twice a day (BID)

Active Comparator: SHR0302 Ointment Dose#2

Drug: SHR0302 Ointment Twice a day (BID)

Group Type: ACTIVE_COMPARATOR

SHR0302 Ointment

Intervention Type: DRUG

SHR0302 Ointment Twice a day (BID)

Active Comparator: SHR0302 Ointment Dose#3

Drug: SHR0302 Ointment Twice a day (BID)

Group Type: ACTIVE_COMPARATOR

SHR0302 Ointment

Intervention Type: DRUG

SHR0302 Ointment Twice a day (BID)

Placebo Comparator: Placebo

Drug: Vehicle Twice a day (BID)

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Twice a day (BID)

Interventions

SHR0302 Ointment

SHR0302 Ointment Twice a day (BID)

Intervention Type: DRUG

SHR0302 Ointment

SHR0302 Ointment Twice a day (BID)

Intervention Type: DRUG

SHR0302 Ointment

SHR0302 Ointment Twice a day (BID)

Intervention Type: DRUG

Vehicle

Twice a day (BID)

Intervention Type: DRUG

Other Intervention Names

SHR0302 Ointment 2%; SHR0302 Ointment 1%; SHR0302 Ointment 0.5%; Placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reistone Biopharma Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhong Cheng

Role: STUDY_DIRECTOR

Reistone Pharma

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China

The First Hospital Affiliated to AMU (Southwest Hospital)

Chongqing, Chongqing Municipality, China

Xinqiao Hospital of AMU

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital Sun Yat-sen University

Guangzhou, Guangdong, China

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Nanyang first people's Hospital

Nanyang, Henan, China

Wuhan NO.1 Hospital

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The Second People's Hospital of Wuxi

Wuxi, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Jiangxi Provincial Hospital of Dermatology

Nanchang, Jiangxi, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, China

SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Hwa Mei Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

The Third Xiangya Hospital of Central South University

Changsha, , China

Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University

Guangzhou, , China

Zhejiang province People's Hospital

Hangzhou, , China

Huashan Hospital Fudan University

Shanghai, , China

Countries

China

Other Identifiers

RSJ10431

Identifier Type: -

Identifier Source: org_study_id