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

Moderate to Severe Atopic Dermatitis Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468956
• Other study ID #: SHR-1819-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: Guangdong Hengrui Pharmaceutical Co., Ltd
• Contact: Xiaoyan Bai
• Phone: 0518-82342973
• Email: xiaoyan.bai[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 650
• Est. completion date: March 31, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. The age was =18 at the time of signing the informed consent and gender is unlimited;

3. 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;

4. EASI = 16, IGA = 3, BSA = 10% during the screening and baseline periods;

5. TCS was not optimal or not tolerated by the investigator.

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate to Severe Atopic Dermatitis

Intervention

Drug:
• SHR-1819
SHR-1819 injection
• Placebo
placebo

Locations

Country	Name	City	State
China	Shanghai Fudan University HuaShan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Hengrui Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	At week 16, the proportion of subjects who achieved EASI-90 (EASI score =90% lower than baseline)	The extent of area is assessed using the EASI scale	up to 16 weeks
Secondary	Proportion of subjects reaching EASI-75 at other visit viewpoints	The extent of area is assessed using the EASI scale	up to 52 weeks
Secondary	The proportion of subjects with IGA score of 0 or 1 and 2 points from baseline	The overall degree of improvement was assessed using the IGA scale	up to 52 weeks
Secondary	Proproportion of subjects with a 2 points from baseline at each iGA	The overall degree of improvement was assessed using the IGA scale	up to 52 weeks
Secondary	Percentage of change and change from baseline in EASI per visit viewpoint	The extent of area is assessed using the EASI scale	up to 52 weeks
Secondary	Percentage of subjects with weekly mean PP-NRS scores of 3 points from baseline	Prtch improvement was assessed using the pruritus scale	up to 52 weeks
Secondary	Percentage of change and change from baseline in the Skin Quality of Life Index Questionnaire (DLQI) score at each visit viewpoint	Subject quality of life was assessed using the DLQI scale	From the beginning of administration to the 52 week
Secondary	Percentage of change from baseline in eczema self-assessment (POEM) scores at each viewpoint	Subject quality of life was assessed using the POEM scale	From the beginning of administration to the 52 week
Secondary	The time of SHR-1819 in the serum	The concentration of SHR-1819 in plasma will be determined	From the beginning of administration to the 52th week
Secondary	The concentration of SHR-1819 in serum: AUC	The concentration of SHR-1819 in plasma will be determined	From the beginning of administration to the 52th week
Secondary	Changes in the level of IgE in the serum	Changes in the level of biomarkers in serum	From the beginning of administration to the 52th week