Efficacy and Safety Study of SHR-1819 Injection in Adult... | NCT06468956

NCT06468956

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Intervention Names
SHR-1819 injection dose 1	Experimental	Drug: SHR-1819
SHR-1819 injection dose 2	Experimental	Drug: SHR-1819
placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SHR-1819	Drug	SHR-1819 injection	SHR-1819 injection dose 1 SHR-1819 injection dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)	The extent of area is assessed using the EASI scale	up to 16 weeks
At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 and a decrease of ≥2 points from baseline	The overall degree of improvement was assessed using the IGA scale	up to 16 week

Secondary Outcomes

Measure	Description	Time Frame
The proportion of subjects whose weekly mean of the daily (PP-NRS) score decreased by 4 points from baseline at Week 16	Prtch improvement was assessed using the pruritus scale	up to 16 weeks
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥90% lower than baseline)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol；
The age was ≥18 at the time of signing the informed consent and gender is unlimited;
Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator;
EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
TCS was not optimal or not tolerated by the investigator.

Exclusion Criteria:

Pregnant or lactating women;
Major surgeries are planned for the duration of the study;
History of previous atopic corneal conjunctivitis involving the cornea;
History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;
Subjects have had or are currently clinically significant diseases or abnormalities;
Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
The drug has been used in the previous 6 months;
Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma);
Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
Any cause that the researchers believe would prevent the participants from participating in the study.