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

• ClinicalTrials.gov Identifier: NCT04162899
• Recruitment Status: Completed
• First Posted: November 14, 2019
• Last Update Posted: December 2, 2020
• Sponsor: Reistone Biopharma Company Limited
• Information provided by (Responsible Party): Reistone Biopharma Company Limited

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)

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Drug: SHR0302	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 6, 2019
• Actual Primary Completion Date: August 21, 2020
• Actual Study Completion Date: August 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active Comparator: SHR0302 dose A; Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.	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).
Active Comparator: Active Comparator: SHR0302 dose B; Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.	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).
Active Comparator: Placebo Comparator: Placebo; Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.	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).

Outcome Measures

Primary Outcome Measures :

1. The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline. [ Time Frame: At week 12 ]
   The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.

Secondary Outcome Measures :

1. Percentage of czema Area and Severity Index (EASI) change. [ Time Frame: 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).
2. Percentage of Subjects Achieving Investigator's Global Score (IGA) Response [ Time Frame: 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.
3. Percent of pruritus numerical rating scale (NRS) change [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

China, Beijing

Peking University People's Hospital

Xicheng, Beijing, China

China, Tianjin

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin, China, 300120

China

Xuanwu Hospital Capital Medical University

Beijing, China, 100053

Peking University Third Hospital

Beijing, China, 100083

Peking union medical college hospital

Beijing, China, 100730

Beijing Tsinghua Changgeng Hospital

Beijing, China, 102218

The Second Xiangya Hospital of Central South University

Changsha, China, 410008

Xiangya Hospital of Central South University

Changsha, China, 410008

The Third Xiangya Hospital of Central South University

Changsha, China, 410013

Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, China, 400037

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China, 350005

Guangdong Provincial People's Hospital

Guangzhou, China, 510000

Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University

Guangzhou, China, 51000

The first affiliated hospital Zhejiang university

Hangzhou, China, 310003

Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine

Hangzhou, China, 310006

Zhejiang province People's Hospital

Hangzhou, China, 310014

Jinan Central Hospital

Jinan, China, 250013

Shanghai Skin Disease Hospital

Shanghai, China, 200050

The first hospital of China medical university

Shenyang, China, 110001

The First Affiliated Hospital of Soochow University

Suzhou, China, 215006

The First Hospital of Shanxi Medical University

Taiyuan, China, 030001

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

Wuhan, China, 430022

Henan provincial people's hospital

Zhengzhou, China, 450003

Sponsors and Collaborators

Reistone Biopharma Company Limited

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Reistone Biopharma Company Limited
• ClinicalTrials.gov Identifier: NCT04162899
• Other Study ID Numbers: RSJ10303
• First Posted: November 14, 2019
• Last Update Posted: December 2, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases