A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis

This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis.

The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Drug: SHR0302

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100083
    • Peking University Third Hospital
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 100053
    • Xuanwu Hospital Capital Medical University
  • Beijing, China, 102218
    • Beijing Tsinghua Changgeng Hospital
  • Changsha, China, 410013
    • The Third Xiangya Hospital of Central South University
  • Changsha, China, 410008
    • Xiangya Hospital of Central South University
  • Changsha, China, 410008
    • The Second Xiangya Hospital of Central South University
  • Chongqing, China, 400037
    • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
  • Fuzhou, China, 350005
    • The First Affiliated Hospital of Fujian Medical University
  • Guangzhou, China, 510000
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 51000
    • Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
  • Hangzhou, China, 310014
    • Zhejiang Province People's Hospital
  • Hangzhou, China, 310003
    • The First Affiliated Hospital Zhejiang University
  • Hangzhou, China, 310006
    • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
  • Jinan, China, 250013
    • Jinan Central Hospital
  • Shanghai, China, 200050
    • Shanghai Skin Disease Hospital
  • Shenyang, China, 110001
    • The First Hospital of China Medical University
  • Suzhou, China, 215006
    • The First Affiliated Hospital of Soochow University
  • Taiyuan, China, 030001
    • The First Hospital of Shanxi Medical University
  • Wuhan, China, 430022
    • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
  • Zhengzhou, China, 450003
    • Henan provincial people's hospital
  • Beijing
    • Xicheng, Beijing, China
      • Peking University People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300120
      • Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
• Moderate to severe atopic dermatitis
• Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

• Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
• Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
• Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: SHR0302 dose A; Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.	Drug: Drug: SHR0302; The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Active Comparator: Active Comparator: SHR0302 dose B; Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.	Drug: Drug: SHR0302; The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Active Comparator: Placebo Comparator: Placebo; Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.	Drug: Drug: SHR0302; The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.	The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.	At week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Achieving Investigator's Global Score (IGA) Response	The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.	Up to week 8
Percentage of Czema Area and Severity Index (EASI) Change.	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).	Up to week 12
Percent of Pruritus Numerical Rating Scale (NRS) Change	The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.	Up to week 12

Collaborators and Investigators

• Sponsor: Reistone Biopharma Company Limited

Publications and helpful links

General Publications

• Zhao Y, Zhang L, Ding Y, Tao X, Ji C, Dong X, Lu J, Wu L, Wang R, Lu Q, Goh AH, Liu R, Zhang Z, Zhang J. Efficacy and Safety of SHR0302, a Highly Selective Janus Kinase 1 Inhibitor, in Patients with Moderate to Severe Atopic Dermatitis: A Phase II Randomized Clinical Trial. Am J Clin Dermatol. 2021 Nov;22(6):877-889. doi: 10.1007/s40257-021-00627-2. Epub 2021 Aug 9.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): August 21, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

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: RSJ10303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No