Back to resultsEfficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
Primary Purpose
Moderate to Severe Atopic Dermatitis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR1819
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Atopic Dermatitis
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；
- Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
- 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;
- At the screening and baseline periods, EASI ≥ 16, IGA ≥3, BSA ≥ 10 %
- 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);
- According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment group A：SHR-1819
Treatment group B：SHR-1819
Treatment group C：SHR-1819
Treatment group D：placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
At week 16, EASI is the percentage change from baseline and change;
The extent of area is assessed using the EASI scale
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
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
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
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
The concentration of SHR-1819 in serum :Cmax
The concentration of SHR-1819 in plasma will be determined
The time of metabolism of the drug in the serum
The concentration of SHR-1819 in plasma will be determined
The concentration of SHR-1819 in serum :AUC
The concentration of SHR-1819 in plasma will be determined
Changes in the level of TARC in the serum
Changes in the level of biomarkers in serum
Changes in the level of CCL17 in the serum
Changes in the level of biomarkers in serum
Changes in the level of IgE in the serum
Changes in the level of biomarkers in serum
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
Changes in the level of immunogenicity in the body
Full Information
NCT ID
NCT05549947
First Posted
September 19, 2022
Last Updated
September 21, 2022
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05549947
Brief Title
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 12, 2022 (Anticipated)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
November 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A：SHR-1819
Arm Type
Experimental
Arm Title
Treatment group B：SHR-1819
Arm Type
Experimental
Arm Title
Treatment group C：SHR-1819
Arm Type
Experimental
Arm Title
Treatment group D：placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR1819
Intervention Description
Treatment group A：SHR-1819 injection dose 1， Treatment group B：SHR-1819 injection dose 2， Treatment group C：SHR-1819 injection dose 3，
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment group D：placebo
Primary Outcome Measure Information:
Title
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)
Description
EASI sore use EASI scale
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
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
Description
The overall degree of improvement was assessed using the IGA scale
Time Frame
up to 16 weeks]
Title
At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥2 points;
Description
The overall degree of improvement was assessed using the IGA scale
Time Frame
up to 16 weeks
Title
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥90% lower than baseline);
Description
The extent of area is assessed using the EASI scale
Time Frame
up to 16 weeks
Title
At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥50% lower than baseline);
Description
The extent of area is assessed using the EASI scale
Time Frame
up to 16 weeks
Title
At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥4 points
Description
The extent of pruritus is assessed using the P-NRS scale
Time Frame
up to 16 weeks
Title
At week 16, EASI is the percentage change from baseline and change;
Description
The extent of area is assessed using the EASI scale
Time Frame
up to 16 weeks
Title
At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change
Description
The extent of lesions and pruritus is assessed using the SCORAD scale
Time Frame
up to 16 weeks
Title
At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change
Description
The BSA scale was used to assess improvement in lesion area
Time Frame
up to 16 weeks
Title
At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change.
Description
The quality of Life is assessed using the DLQI scale
Time Frame
up to 16 weeks
Title
The incidence of adverse events ranged from the first dose to 24 weeks
Description
Assess the post-medication safety of subjects from the first dose to the time they exit the group
Time Frame
From the beginning of administration to the 24th week
Title
The concentration of SHR-1819 in serum :Cmax
Description
The concentration of SHR-1819 in plasma will be determined
Time Frame
From the beginning of administration to the 24th week
Title
The time of metabolism of the drug in the serum
Description
The concentration of SHR-1819 in plasma will be determined
Time Frame
From the beginning of administration to the 24th week
Title
The concentration of SHR-1819 in serum :AUC
Description
The concentration of SHR-1819 in plasma will be determined
Time Frame
From the beginning of administration to the 24th week
Title
Changes in the level of TARC in the serum
Description
Changes in the level of biomarkers in serum
Time Frame
From the beginning of administration to the 24th week
Title
Changes in the level of CCL17 in the serum
Description
Changes in the level of biomarkers in serum
Time Frame
From the beginning of administration to the 24th week
Title
Changes in the level of IgE in the serum
Description
Changes in the level of biomarkers in serum
Time Frame
From the beginning of administration to the 24th week
Title
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
Description
Changes in the level of immunogenicity in the body
Time Frame
From the beginning of administration to the 24th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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；
Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
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;
At the screening and baseline periods, EASI ≥ 16, IGA ≥3, BSA ≥ 10 %
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);
According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuling Lian, M.D.
Phone
0518-82342973
Email
yuling.lian@hengrui.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
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