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 Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacokinetics of SHR-1819 Injection in Adults With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549947
• Other study ID #: SHR-1819-201
• Status: Completed
• Phase: Phase 2
• Start date: October 8, 2022
• Est. completion date: November 23, 2023

Study information

• Verified date: January 2024
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• 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: Completed
• Enrollment: 158
• Est. completion date: November 23, 2023
• Est. primary completion date: September 15, 2023
• 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. 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• SHR1819
Treatment group A:SHR-1819 injection dose 1, Treatment group B:SHR-1819 injection dose 2, Treatment group C:SHR-1819 injection dose 3,
• Placebo
Treatment group D:placebo

Locations

Country	Name	City	State
China	Huashan Sub-Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

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