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

NCT ID: NCT04162899

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2020-08-31

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)

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Comparator: SHR0302 dose A

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

Group Type: ACTIVE_COMPARATOR

Drug: SHR0302

Intervention Type: DRUG

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: SHR0302 dose B

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

Group Type: ACTIVE_COMPARATOR

Drug: SHR0302

Intervention Type: DRUG

The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

Placebo Comparator: Placebo

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

Group Type: ACTIVE_COMPARATOR

Drug: SHR0302

Intervention Type: DRUG

The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

Interventions

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).

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reistone Biopharma Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Xicheng, Beijing Municipality, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, China

Xuanwu Hospital Capital Medical University

Beijing, , China

Peking University Third Hospital

Beijing, , China

Peking union medical college hospital

Beijing, , China

Beijing Tsinghua Changgeng Hospital

Beijing, , China

The Second Xiangya Hospital of Central South University

Changsha, , China

Xiangya Hospital of Central South University

Changsha, , China

The Third 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

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

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

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, , China

Henan provincial people's hospital

Zhengzhou, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34374027 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RSJ10303

Identifier Type: -

Identifier Source: org_study_id