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

Atopic Dermatitis Clinical Trial

— MARBLE-23  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04717310
• Other study ID #: RSJ10431
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: December 30, 2020
• Est. completion date: July 14, 2024

Study information

• Verified date: August 2023
• Source: Reistone Biopharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 645
• Est. completion date: July 14, 2024
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• SHR0302 Ointment
SHR0302 Ointment Twice a day (BID)
• SHR0302 Ointment
SHR0302 Ointment Twice a day (BID)
• SHR0302 Ointment
SHR0302 Ointment Twice a day (BID)
• Vehicle
Twice a day (BID)

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Chang chun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing Traditional Chinese Medicine Hospital	Chongqing	Chongqing
China	The First Hospital Affiliated to AMU (Southwest Hospital)	Chongqing	Chongqing
China	Xinqiao Hospital of AMU	Chongqing	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University	Guangzhou
China	The First Affiliated Hospital Sun Yat-sen University	Guangzhou	Guangdong
China	Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Hangzhou Third People's Hospital	Hangzhou	Zhejiang
China	SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang province People's Hospital	Hangzhou
China	Anhui Provincial Hospital	Hefei	Anhui
China	Jiangxi Provincial Hospital of Dermatology	Nanchang	Jiangxi
China	Nanyang first people's Hospital	Nanyang	Henan
China	Hwa Mei Hospital	Ningbo	Zhejiang
China	Huashan Hospital Fudan University	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Skin Disease Hospital	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan NO.1 Hospital	Wuhan	Hubei
China	The Second People's Hospital of Wuxi	Wuxi	Jiangsu
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8	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	8 weeks