A Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult and Adolescent Patients With Mild-to-Moderate Atopic Dermatitis

Who is this study for? Adult and adolescent patients with Moderate to Severe Atopic Dermatitis
What treatments are being studied? SHR0302
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This is a Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult and Adolescent Patients with Mild-to-Moderate Atopic Dermatitis. It will consist of phase II and phase III parts, phase II will be a dose-ranging part and phase III will be a pivotal study part.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: No
View:

• Male or female subject at ≥12 years of age at time of informed consent.

• Have mild-to- moderate AD (Atopic Dermatitis), as determined by all of the following:

• Were diagnosed with AD (defined by the Hanifin and Rajka criteria)

• With AD history at least 6 months

• Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

• All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from signing of informed consent, throughout the duration of the study, and for 28 days after last dose of study medication.

Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
Not yet recruiting
Beijing
Beijing Hospital
Not yet recruiting
Beijing
The Third Xiangya Hospital of Central South University
Not yet recruiting
Changsha
West China Hospital of Sichuan University
Not yet recruiting
Chengdu
Chongqing Traditional Chinese Medicine Hospital
Not yet recruiting
Chongqing
The First Hospital Affiliated to AMU (Southwest Hospital)
Not yet recruiting
Chongqing
Xinqiao Hospital of AMU
Not yet recruiting
Chongqing
The First Affiliated Hospital of Fujian Medical University
Not yet recruiting
Fuzhou
Dermatology Hospital of Southern Medical University
Not yet recruiting
Guangzhou
Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
Not yet recruiting
Guangzhou
The First Affiliated Hospital Sun Yat-sen University
Not yet recruiting
Guangzhou
Affiliated Hospital of Guizhou Medical University
Not yet recruiting
Guiyang
Hangzhou First People's Hospital
Not yet recruiting
Hangzhou
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
Not yet recruiting
Hangzhou
Zhejiang province People's Hospital
Recruiting
Hangzhou
Hwa Mei Hospital
Recruiting
Ningbo
Huashan Hospital Affiliated To Fudan University
Recruiting
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Not yet recruiting
Shanghai
Shanghai Skin Disease Hospital
Not yet recruiting
Shanghai
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Not yet recruiting
Tianjin
Affiliated Hospital of Jiangsu University
Recruiting
Zhenjiang
Contact Information
Primary
Lingyu Guo
lingyu.guo@reistonebio.com
847.293.7866
Backup
Imran Ghiasuddin
imran.ghiasuddin@reistonebio.com
847.293.7866
Time Frame
Start Date: December 30, 2020
Estimated Completion Date: June 30, 2024
Participants
Target number of participants: 461
Treatments
Active Comparator: Active Comparator: SHR0302 Ointment Dose#1
Drug: SHR0302 Ointment Twice a day (BID)
Active Comparator: Active Comparator: SHR0302 Ointment Dose#2
Drug: SHR0302 Ointment Twice a day (BID)
Active Comparator: Active Comparator: SHR0302 Ointment Dose#3
Drug: SHR0302 Ointment Twice a day (BID)
Placebo Comparator: Placebo Comparator: Placebo
Drug: Vehicle Twice a day (BID)
Related Therapeutic Areas

This content was sourced from clinicaltrials.gov