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

Phase 2

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT04162899
• Lead Sponsor: Reistone Biopharma Company Limited

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-15
• Study Start: 2019-11-06
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Primary Completion: 2020-08-21
• Study Completion: 2020-08-31
• Status Verified: 2022-06
• Results First Submitted: 2022-06-28
• Results First Submitted QC: 2022-06-28
• Last Update Submitted: 2022-06-28
• Results First Posted: 2023-05-09
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.	At week 12	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

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

Trial Locations

Locations (23)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, China

Beijing Tsinghua Changgeng Hospital; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Xicheng, Beijing, China

Jinan Central Hospital; 🇨🇳 Jinan, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Peking union medical college hospital; 🇨🇳 Beijing, China

Shanghai Skin Disease Hospital; 🇨🇳 Shanghai, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, China

Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University; 🇨🇳 Guangzhou, China

The First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, China

Henan provincial people's hospital; 🇨🇳 Zhengzhou, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital; 🇨🇳 Tianjin, Tianjin, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Second Affiliated Hospital of Army Medical University (Xinqiao Hospital); 🇨🇳 Chongqing, China

The first affiliated hospital Zhejiang university; 🇨🇳 Hangzhou, China

Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine; 🇨🇳 Hangzhou, China

Zhejiang province People's Hospital; 🇨🇳 Hangzhou, China

The first hospital of China medical university; 🇨🇳 Shenyang, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, China