Status:
UNKNOWN
Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis
Lead Sponsor:
Reistone Biopharma Company Limited
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 Patients with Mild-to...
Detailed Description
This study will evaluate the topical SHR0302 ointment, a JAK (Janus Kinase) inhibitor, in atopic dermatitis patients. The EASI (Eczema Area and Severity Index), IGA (immunoglobulin A), SCORAD (Scoring...
Eligibility Criteria
Inclusion
- Male or female subject at least at ≥18 and ≤75years 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.
Exclusion
- Subjects currently have active forms of other skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with evaluation of the effect of study medication on atopic dermatitis, or skin infections (bacteria, fungi, or viruses), or diseases that can cause skin itching (such as itching caused by diabetes), or subjects who are allergic to topical skin drugs
- Subjects with serious concomitant illness that could require administering of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g. unstable chronic asthma)
- Subjects who have a history of mental illness or disease such as anxiety and depression, and are not suitable to participate in this study
- Subjects with serious and uncontrolled disease that may affect the safety of the subject, compliance, affect the evaluation of the endpoint, or require the use of drugs that are not allowed in the protocol
- Subjects with Human immunodeficiency virus (HIV), or hepatitis B virus ,or hepatitis C virus ,or syphilis related laboratory test positive (subjects positive for hepatitis B surface antigen, HBV (hepatitis B virus) DNA must be greater than lower limit of detection
- Subjects with malignant tumors or a history of malignant tumors, except for fully treated or resected skin non-metastatic basal cell carcinoma or squamous cell carcinoma
- Pregnant female subjects, breastfeeding female subjects, or male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in protocol for the duration of the study and for at least 28 days after last dose of investigational product.
- The investigators determined that there were conditions that affected the safety and efficacy of the investigational drug
- Subjects who, in the opinion of the investigator or Reistone, will be unsuitable for inclusion in the study.
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2024
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT04717310
Start Date
December 30 2020
End Date
July 14 2024
Last Update
September 5 2023
Active Locations (31)
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1
Anhui Provincial Hospital
Hefei, Anhui, China
2
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
3
Beijing Hospital
Beijing, Beijing Municipality, China
4
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China