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

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

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

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Atopic Dermatitis
• Intervention / Treatment: Drug: SHR1819; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yuling Lian, M.D.; Phone Number: 0518-82342973; Email: yuling.lian@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Sub-Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A：SHR-1819	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，
Experimental: Treatment group B：SHR-1819	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，
Experimental: Treatment group C：SHR-1819	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 Comparator: Treatment group D：placebo	Drug: Placebo; Treatment group D：placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	EASI sore use EASI scale	up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: SHR-1819-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No