Clinical trial NCT05549947: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Atopic Dermatitis
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)
timeFrame: up to 16 weeks
Secondary outcomes:
measure: 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
timeFrame: up to 16 weeks]
measure: At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥2 points;
timeFrame: up to 16 weeks
measure: At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥90% lower than baseline);
timeFrame: up to 16 weeks
measure: At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥50% lower than baseline);
timeFrame: up to 16 weeks
measure: At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥4 points
timeFrame: up to 16 weeks
measure: At week 16, EASI is the percentage change from baseline and change;
timeFrame: up to 16 weeks
measure: At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change
timeFrame: up to 16 weeks
measure: At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change
timeFrame: up to 16 weeks
measure: At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change.
timeFrame: up to 16 weeks
measure: The incidence of adverse events ranged from the first dose to 24 weeks
timeFrame: From the beginning of administration to the 24th week
measure: The concentration of SHR-1819 in serum :Cmax
timeFrame: From the beginning of administration to the 24th week
measure: The time of metabolism of the drug in the serum
timeFrame: From the beginning of administration to the 24th week
measure: The concentration of SHR-1819 in serum :AUC
timeFrame: From the beginning of administration to the 24th week
measure: Changes in the level of TARC in the serum
timeFrame: From the beginning of administration to the 24th week
measure: Changes in the level of CCL17 in the serum
timeFrame: From the beginning of administration to the 24th week
measure: Changes in the level of IgE in the serum
timeFrame: From the beginning of administration to the 24th week
measure: Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
timeFrame: From the beginning of administration to the 24th week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Sub-Hospital of Fudan University
state: Shanghai
Study officials:
References: