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
1 other identifier
interventional
105
1 country
23
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2019
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2019
CompletedStudy Start
First participant enrolled
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedResults Posted
Study results publicly available
May 9, 2023
CompletedMay 9, 2023
June 1, 2022
10 months
October 15, 2019
June 28, 2022
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentage of Czema Area and Severity Index (EASI) Change.
Up to week 12
Percentage of Subjects Achieving Investigator's Global Score (IGA) Response
Up to week 8
Percent of Pruritus Numerical Rating Scale (NRS) Change
Up to week 12
Study Arms (3)
Active Comparator: SHR0302 dose A
ACTIVE COMPARATORParticipants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.
Active Comparator: SHR0302 dose B
ACTIVE COMPARATORParticipants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.
Placebo Comparator: Placebo
ACTIVE COMPARATORParticipants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.
Interventions
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Peking University People's Hospital
Xicheng, Beijing Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Peking University Third Hospital
Beijing, 100083, China
Peking union medical college hospital
Beijing, 100730, China
Beijing Tsinghua Changgeng Hospital
Beijing, 102218, China
The Second Xiangya Hospital of Central South University
Changsha, 410008, China
Xiangya Hospital of Central South University
Changsha, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, 410013, China
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, 400037, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005, China
Guangdong Provincial People's Hospital
Guangzhou, 510000, China
Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
Guangzhou, 51000, China
The first affiliated hospital Zhejiang university
Hangzhou, 310003, China
Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine
Hangzhou, 310006, China
Zhejiang province People's Hospital
Hangzhou, 310014, China
Jinan Central Hospital
Jinan, 250013, China
Shanghai Skin Disease Hospital
Shanghai, 200050, China
The first hospital of China medical university
Shenyang, 110001, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
The First Hospital of Shanxi Medical University
Taiyuan, 030001, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022, China
Henan provincial people's hospital
Zhengzhou, 450003, China
Related Publications (1)
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.
PMID: 34374027DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roger Liu, Medical Director
- Organization
- ReistoneBiopharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2019
First Posted
November 14, 2019
Study Start
November 6, 2019
Primary Completion
August 21, 2020
Study Completion
August 31, 2020
Last Updated
May 9, 2023
Results First Posted
May 9, 2023
Record last verified: 2022-06