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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162899
• Other study ID #: RSJ10303
• Status: Completed
• Phase: Phase 2
• Start date: November 6, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2022
• Source: Reistone Biopharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 31, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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