Clinical trial NCT04162899: A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Reistone Biopharma Company Limited
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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)

Primary outcomes:
measure: The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
timeFrame: At week 12
Secondary outcomes:
measure: Percentage of Czema Area and Severity Index (EASI) Change.
timeFrame: Up to week 12
measure: Percentage of Subjects Achieving Investigator's Global Score (IGA) Response
timeFrame: Up to week 8
measure: Percent of Pruritus Numerical Rating Scale (NRS) Change
timeFrame: Up to week 12
Other outcomes:
Locations:
city: Xicheng
country: China
facility: Peking University People's Hospital
state: Beijing
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking union medical college hospital
city: Beijing
country: China
facility: Beijing Tsinghua Changgeng Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
city: Hangzhou
country: China
facility: The first affiliated hospital Zhejiang university
city: Hangzhou
country: China
facility: Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine
city: Hangzhou
country: China
facility: Zhejiang province People's Hospital
city: Jinan
country: China
facility: Jinan Central Hospital
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
city: Shenyang
country: China
facility: The first hospital of China medical university
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
city: Wuhan
country: China
facility: Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
city: Zhengzhou
country: China
facility: Henan provincial people's hospital
Study officials:
References:
citation: 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.