Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05549947
Other study ID # SHR-1819-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06012812 - A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis Phase 2
Recruiting NCT06136741 - A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis Phase 2
Recruiting NCT06099704 - Observational Study of Canadian Patients (6 Years or Older) Receiving Dupixent® for Moderate to Severe Atopic Dermatitis
Completed NCT03568162 - Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT00148746 - Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis N/A
Recruiting NCT05702268 - Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis Phase 2
Not yet recruiting NCT06468956 - Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis Phase 3
Recruiting NCT05997927 - Efficacy and Safety Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis Phase 2
Not yet recruiting NCT05197023 - A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS Phase 1
Recruiting NCT06239311 - Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis. Phase 3
Terminated NCT01286220 - Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis N/A
Completed NCT02426359 - Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients Phase 2