Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

Phase 2

Completed

• Conditions: Moderate to Severe Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: SHR1819

• Registration Number: NCT05549947
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-22
• Study Start: 2022-10-08
• Primary Completion: 2023-09-15
• Study Completion: 2023-11-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

1. 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；
2. Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
3. Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening;
4. At the screening and baseline periods, EASI ≥ 16, IGA ≥3, BSA ≥ 10 %
5. The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected);
6. According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening

Exclusion Criteria

1. Pregnant or lactating women
2. Major surgeries are planned for the duration of the study
3. History of previous atopic corneal conjunctivitis involving the cornea
4. 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.
5. Subjects have had or are currently clinically significant diseases or abnormalities
6. Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening
7. The drug has been used in the previous 6 months
8. 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)
9. Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation
10. Any cause that the researchers believe would prevent the participants from participating in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group D：placebo	Placebo	-
Treatment group A：SHR-1819	SHR1819	-
Treatment group C：SHR-1819	SHR1819	-
Treatment group B：SHR-1819	SHR1819	-

Primary Outcome Measures

Name	Time	Method
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)	up to 16 weeks	EASI sore use EASI scale

Secondary Outcome Measures

Name	Time	Method
Changes in the level of CCL17 in the serum	From the beginning of administration to the 24th week	Changes in the level of biomarkers in serum
At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change.	up to 16 weeks	The quality of Life is assessed using the DLQI scale
The concentration of SHR-1819 in serum :Cmax	From the beginning of administration to the 24th week	The concentration of SHR-1819 in plasma will be determined
At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change	up to 16 weeks	The extent of lesions and pruritus is assessed using the SCORAD scale
At week 16, EASI is the percentage change from baseline and change;	up to 16 weeks	The extent of area is assessed using the EASI scale
At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change	up to 16 weeks	The BSA scale was used to assess improvement in lesion area
At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥2 points;	up to 16 weeks	The overall degree of improvement was assessed using the IGA scale
Changes in the level of TARC in the serum	From the beginning of administration to the 24th week	Changes in the level of biomarkers in serum
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819	From the beginning of administration to the 24th week	Changes in the level of immunogenicity in the body
The concentration of SHR-1819 in serum :AUC	From the beginning of administration to the 24th week	The concentration of SHR-1819 in plasma will be determined
Changes in the level of IgE in the serum	From the beginning of administration to the 24th week	Changes in the level of biomarkers in serum
At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥2 points from baseline	up to 16 weeks]	The overall degree of improvement was assessed using the IGA scale
The incidence of adverse events ranged from the first dose to 24 weeks	From the beginning of administration to the 24th week	Assess the post-medication safety of subjects from the first dose to the time they exit the group
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥90% lower than baseline);	up to 16 weeks	The extent of area is assessed using the EASI scale
At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥50% lower than baseline);	up to 16 weeks	The extent of area is assessed using the EASI scale
At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥4 points	up to 16 weeks	The extent of pruritus is assessed using the P-NRS scale
The time of metabolism of the drug in the serum	From the beginning of administration to the 24th week	The concentration of SHR-1819 in plasma will be determined

Trial Locations

Locations (1)

Huashan Sub-Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China