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Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis (MARBLE-23)

Primary Purpose

Atopic Dermatitis

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR0302 Ointment
SHR0302 Ointment
SHR0302 Ointment
Vehicle
Sponsored by
Reistone Biopharma Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Provincial Hospital
  • Beijing Friendship Hospital, Capital Medical University
  • Beijing Hospital
  • Chongqing Traditional Chinese Medicine Hospital
  • The First Hospital Affiliated to AMU (Southwest Hospital)
  • Xinqiao Hospital of AMU
  • The First Affiliated Hospital of Fujian Medical University
  • Dermatology Hospital of Southern Medical University
  • The First Affiliated Hospital Sun Yat-sen University
  • Affiliated Hospital of Guizhou Medical University
  • Nanyang first people's Hospital
  • Wuhan NO.1 Hospital
  • The Second Xiangya Hospital of Central South University
  • The Second People's Hospital of Wuxi
  • Affiliated Hospital of Jiangsu University
  • Jiangxi Provincial Hospital of Dermatology
  • The Second Hospital of Jilin University
  • Shengjing Hospital of China Medical University
  • Shanghai Skin Disease Hospital
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • West China Hospital of Sichuan University
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
  • Hangzhou First People's Hospital
  • Hangzhou Third People's Hospital
  • Hwa Mei Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • The Third Xiangya Hospital of Central South University
  • Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
  • Zhejiang province People's Hospital
  • Huashan Hospital Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Active Comparator: SHR0302 Ointment Dose#1

Active Comparator: SHR0302 Ointment Dose#2

Active Comparator: SHR0302 Ointment Dose#3

Placebo Comparator: Placebo

Arm Description

Drug: SHR0302 Ointment Twice a day (BID)

Drug: SHR0302 Ointment Twice a day (BID)

Drug: SHR0302 Ointment Twice a day (BID)

Drug: Vehicle Twice a day (BID)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2021
Last Updated
August 31, 2023
Sponsor
Reistone Biopharma Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04717310
Brief Title
Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
September 8, 2023 (Anticipated)
Study Completion Date
July 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reistone Biopharma Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
645 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: SHR0302 Ointment Dose#1
Arm Type
Active Comparator
Arm Description
Drug: SHR0302 Ointment Twice a day (BID)
Arm Title
Active Comparator: SHR0302 Ointment Dose#2
Arm Type
Active Comparator
Arm Description
Drug: SHR0302 Ointment Twice a day (BID)
Arm Title
Active Comparator: SHR0302 Ointment Dose#3
Arm Type
Active Comparator
Arm Description
Drug: SHR0302 Ointment Twice a day (BID)
Arm Title
Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Vehicle Twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
SHR0302 Ointment
Other Intervention Name(s)
SHR0302 Ointment 2%
Intervention Description
SHR0302 Ointment Twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
SHR0302 Ointment
Other Intervention Name(s)
SHR0302 Ointment 1%
Intervention Description
SHR0302 Ointment Twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
SHR0302 Ointment
Other Intervention Name(s)
SHR0302 Ointment 0.5%
Intervention Description
SHR0302 Ointment Twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
Twice a day (BID)
Primary Outcome Measure Information:
Title
Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhong Cheng
Organizational Affiliation
Reistone Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Traditional Chinese Medicine Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The First Hospital Affiliated to AMU (Southwest Hospital)
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Xinqiao Hospital of AMU
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Nanyang first people's Hospital
City
Nanyang
State/Province
Henan
Country
China
Facility Name
Wuhan NO.1 Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The Second People's Hospital of Wuxi
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Provincial Hospital of Dermatology
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The Second Hospital of Jilin University
City
Chang chun
State/Province
Jilin
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300120
Country
China
Facility Name
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Hangzhou Third People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Hwa Mei Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
City
Guangzhou
ZIP/Postal Code
51000
Country
China
Facility Name
Zhejiang province People's Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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