Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

PHASE3CompletedINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

August 12, 2022

Study Completion Date

May 23, 2023

Conditions
Atopic Dermatitis
Interventions
DRUG

Core Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

DRUG

Core Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks

DRUG

Core Treatment Placebo Comparator: Placebo

Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks

DRUG

Extension Treatment Active Experimental: SHR0302 Dose#1

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

DRUG

Extension Treatment Active Experimental: SHR0302 Dose#2

Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks

Trial Locations (52)

100044

Peking University People's Hospital, Beijing

100045

Beijing Children's Hospital, Capital Medical University, Beijing

100191

Peking University third hospital, Beijing

100730

Peking union medical college hospital, Beijing

110001

The first hospital of China medical university, Shenyang

300120

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin

310003

The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

310014

Zhejiang province People's Hospital, Hangzhou

410008

Xiangya Hospital of Central South University, Changsha

410013

The Third Xiangya Hospital of Central South University, Changsha

T2J 7E1

Dermatology Research Institute Inc., Calgary

V3R 6A7

Dr Chih-ho Hong Medical Inc., Surrey

V3V 0C6

Enverus Medical Research, Surrey

R3M 3Z4

Wiseman Dermatology Research, Winnipeg

L1S 7K8

CCA Medical Research, Ajax

K9A 0Z4

SKiN Health, Cobourg

N6H 5L5

DermEffects, London

M2M 4J5

North York Research Inc., North York

L4B 1A5

The Centre for Dermatology, Richmond Hill

L4C 9M7

York Dermatology, Richmond Hill

M3H 5Y8

Toronto Research Centre, Toronto

M4W 2N4

Research Toronto, Toronto

M5A 3R6

AvantDerm, Toronto

N8W 1E6

XLR8 Clinical Research, Windsor

H7N 6L2

Clinique D, Laval

Unknown

First Affiliated Hospital of Anhui Medical University, Hefei

The second Affiliated Hospital of Anhui Medical University, Hefei

First Affiliated Hospital of Fujian Medical University, Fuzhou

Zhongshan Hospital, Fudan University(Xiamen Branch), Xiamen

Dermatology Hospital of Southern Medical University, Guangzhou

Guangdong Province Traditional Chinese Medical Hospital, Guangzhou

The First affiliated Hospital, Sun Yat-sen University, Guangzhou

Wuhan No.1 Hospital, Wuhan

The Second Xiangya Hospital of Central South University, Changsha

Hospital for Skin Diseases, Chinese Academy of medical sciences, Nanjing

Jiangsu province people's hospital, Nanjing

Wuxi No.2 People's Hospital, Wuxi

Affiliated Hospital of Jiangsu University, Zhenjiang

Jiangxi Provincial Hospital of Dermatology, Nanchang

The First Affiliated Hospital of Nanchang University, Nanchang

The second Affiliated Hospital of Nanchang University, Nanchang

The first hospital of jilin university, Changchun

West China Hospital of Sichuan University, Chengdu

The Children's Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou

The first people's hospital of hangzhou, Hangzhou

The fourth hospital affiliated to zhejiang university school of medicine, Yiwu

Children's Hospital Capital Institute of Pediatrics, Beijing

Chongqing Traditional Chinese medicine Hospital, Chongqing

First affiliated hospital of chongqing medical university, Chongqing

The Southwest Hospital of AMU, Chongqing

Dermatology hospital of Shanghai, Shanghai

Huashan Hospital Affiliated to Fudan University, Shanghai

All Listed Sponsors
lead

Reistone Biopharma Company Limited

INDUSTRY