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

Sponsor
Reistone Biopharma Company Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04717310
Collaborator
(none)
461
Enrollment
21
Locations
4
Arms
42
Anticipated Duration (Months)
22
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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 and Adolescent 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR0302 Ointment
  • Drug: SHR0302 Ointment
  • Drug: SHR0302 Ointment
  • Drug: Vehicle
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
461 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 and Adolescent Patients With Mild-to-Moderate Atopic Dermatitis
Actual Study Start Date :
Dec 30, 2020
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Comparator: SHR0302 Ointment Dose#1

Drug: SHR0302 Ointment Twice a day (BID)

Drug: SHR0302 Ointment
SHR0302 Ointment Twice a day (BID)
Other Names:
  • SHR0302 Ointment 2%

    		•
    Active Comparator: Active Comparator: SHR0302 Ointment Dose#2

    Drug: SHR0302 Ointment Twice a day (BID)

    Drug: SHR0302 Ointment
    SHR0302 Ointment Twice a day (BID)
    Other Names:
  • SHR0302 Ointment 1%

    		•
    Active Comparator: Active Comparator: SHR0302 Ointment Dose#3

    Drug: SHR0302 Ointment Twice a day (BID)

    Drug: SHR0302 Ointment
    SHR0302 Ointment Twice a day (BID)
    Other Names:
  • SHR0302 Ointment 0.5%

    		•
    Placebo Comparator: Placebo Comparator: Placebo

    Drug: Vehicle Twice a day (BID)

    Drug: Vehicle
    Twice a day (BID)
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8 [8 weeks]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female subject at ≥12 years 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 or equal to 500 copies/ml)

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050
    2 Beijing Hospital Beijing Beijing China
    3 Chongqing Traditional Chinese Medicine Hospital Chongqing Chongqing China
    4 The First Hospital Affiliated to AMU (Southwest Hospital) Chongqing Chongqing China
    5 Xinqiao Hospital of AMU Chongqing Chongqing China
    6 The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005
    7 Dermatology Hospital of Southern Medical University Guangzhou Guangdong China
    8 The First Affiliated Hospital Sun Yat-sen University Guangzhou Guangdong China
    9 Affiliated Hospital of Guizhou Medical University Guiyang Guizhou China
    10 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China
    11 Shanghai Skin Disease Hospital Shanghai Shanghai China 200071
    12 Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai China
    13 West China Hospital of Sichuan University Chengdu Sichuan China
    14 Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital Tianjin Tianjin China 300120
    15 SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China 310020
    16 Hangzhou First People's Hospital Hangzhou Zhejiang China
    17 Hwa Mei Hospital Ningbo Zhejiang China
    18 The Third Xiangya Hospital of Central South University Changsha China 410013
    19 Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University Guangzhou China 51000
    20 Zhejiang province People's Hospital Hangzhou China 310014
    21 Huashan Hospital Affiliated To Fudan University Shanghai China

    Sponsors and Collaborators

    • Reistone Biopharma Company Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reistone Biopharma Company Limited
    ClinicalTrials.gov Identifier:
    NCT04717310
    Other Study ID Numbers:
    • RSJ10431
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Jun 6, 2022