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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: SHR0302 Ointment; Drug: Vehicle

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 Type: Interventional
• Enrollment (Actual): 645
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Changsha, China, 410013
    • The Third Xiangya Hospital of Central South University
  • Guangzhou, China, 51000
    • Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
  • Hangzhou, China, 310014
    • Zhejiang Province People's Hospital
  • Shanghai, China
    • Huashan Hospital Fudan University
  • Anhui
    • Hefei, Anhui, China
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • Chongqing Traditional Chinese Medicine Hospital
    • Chongqing, Chongqing, China
      • The First Hospital Affiliated to AMU (Southwest Hospital)
    • Chongqing, Chongqing, China
      • Xinqiao Hospital of AMU
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital Of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital Sun Yat-Sen University
  • Guizhou
    • Guiyang, Guizhou, China
      • Affiliated Hospital of Guizhou Medical University
  • Henan
    • Nanyang, Henan, China
      • Nanyang First People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan No.1 hospital
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital Of Central South University
  • Jiangsu
    • Wuxi, Jiangsu, China
      • The Second People's Hospital of Wuxi
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial Hospital of Dermatology
  • Jilin
    • Chang chun, Jilin, China
      • The Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • Shengjing Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Shanghai skin disease hospital
    • Shanghai, Shanghai, China
      • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300120
      • Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Hangzhou Third People's Hospital
    • Ningbo, Zhejiang, China
      • Hwa Mei Hospital
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 0.5%
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 0.5%
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Reistone Biopharma Company Limited
• Investigators: Study Director: Yanhong Cheng, Reistone Pharma

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Estimated): September 8, 2023
• Study Completion (Estimated): July 14, 2024

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: RSJ10431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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