search
Back to results

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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Drug: SHR0302
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:

  • 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)

Sites / Locations

  • Peking University People's Hospital
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Xuanwu Hospital Capital Medical University
  • Peking University Third Hospital
  • Peking union medical college hospital
  • Beijing Tsinghua Changgeng Hospital
  • The Second Xiangya Hospital of Central South University
  • Xiangya Hospital of Central South University
  • The Third Xiangya Hospital of Central South University
  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
  • The First Affiliated Hospital of Fujian Medical University
  • Guangdong Provincial People's Hospital
  • Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
  • The first affiliated hospital Zhejiang university
  • Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine
  • Zhejiang province People's Hospital
  • Jinan Central Hospital
  • Shanghai Skin Disease Hospital
  • The first hospital of China medical university
  • The First Affiliated Hospital of Soochow University
  • The First Hospital of Shanxi Medical University
  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
  • Henan provincial people's hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Active Comparator: SHR0302 dose A

Active Comparator: SHR0302 dose B

Placebo Comparator: Placebo

Arm Description

Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.

Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.

Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
October 15, 2019
Last Updated
June 28, 2022
Sponsor
Reistone Biopharma Company Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT04162899
Brief Title
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
August 21, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)

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
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: SHR0302 dose A
Arm Type
Active Comparator
Arm Description
Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.
Arm Title
Active Comparator: SHR0302 dose B
Arm Type
Active Comparator
Arm Description
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.
Arm Title
Placebo Comparator: Placebo
Arm Type
Active Comparator
Arm Description
Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.
Intervention Type
Drug
Intervention Name(s)
Drug: SHR0302
Intervention Description
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Primary Outcome Measure Information:
Title
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
Description
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.
Time Frame
At week 12
Secondary Outcome Measure Information:
Title
Percentage of Czema Area and Severity Index (EASI) Change.
Description
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Time Frame
Up to week 12
Title
Percentage of Subjects Achieving Investigator's Global Score (IGA) Response
Description
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.
Time Frame
Up to week 8
Title
Percent of Pruritus Numerical Rating Scale (NRS) Change
Description
The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
Time Frame
Up to week 12

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: 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)
Facility Information:
Facility Name
Peking University People's Hospital
City
Xicheng
State/Province
Beijing
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
Xuanwu Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Peking union medical college hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Tsinghua Changgeng Hospital
City
Beijing
ZIP/Postal Code
102218
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
City
Guangzhou
ZIP/Postal Code
51000
Country
China
Facility Name
The first affiliated hospital Zhejiang university
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine
City
Hangzhou
ZIP/Postal Code
310006
Country
China
Facility Name
Zhejiang province People's Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
The first hospital of China medical university
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Henan provincial people's hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34374027
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs