Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis
MARBLE-23
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
1 other identifier
interventional
645
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2020
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2024
CompletedSeptember 5, 2023
August 1, 2023
2.7 years
January 15, 2021
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Active Comparator: SHR0302 Ointment Dose#1
ACTIVE COMPARATORDrug: SHR0302 Ointment Twice a day (BID)
Active Comparator: SHR0302 Ointment Dose#2
ACTIVE COMPARATORDrug: SHR0302 Ointment Twice a day (BID)
Active Comparator: SHR0302 Ointment Dose#3
ACTIVE COMPARATORDrug: SHR0302 Ointment Twice a day (BID)
Placebo Comparator: Placebo
PLACEBO COMPARATORDrug: Vehicle Twice a day (BID)
Interventions
SHR0302 Ointment Twice a day (BID)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, 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, 350005, 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, 200071, 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, 300120, China
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020, 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, 410013, China
Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
Guangzhou, 51000, China
Zhejiang province People's Hospital
Hangzhou, 310014, China
Huashan Hospital Fudan University
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yanhong Cheng
Reistone Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 22, 2021
Study Start
December 30, 2020
Primary Completion
September 8, 2023
Study Completion
July 14, 2024
Last Updated
September 5, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share