Clinical trial NCT06468956: Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1819 Injection in Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderate to Severe Atopic Dermatitis
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 650
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. The age was ≥18 at the time of signing the informed consent and gender is unlimited;
3. Atopic dermatitis at screening (according to the 2014 American Society of Dermatology guideline criteria, see Annex 1) and disease duration for at least 1 year before screening as judged by the investigator;
4. EASI ≥ 16, IGA ≥ 3, BSA ≥ 10% during the screening and baseline periods;
5. TCS was not optimal or not tolerated by the investigator.

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
measure: At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 and a decrease of ≥2 points from baseline
timeFrame: up to 16 week
Secondary outcomes:
measure: The proportion of subjects whose weekly mean of the daily (PP-NRS) score decreased by 4 points from baseline at Week 16
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: Proportion of subjects reaching EASI-75 at other visit viewpoints
timeFrame: up to 52 weeks
measure: The proportion of subjects with IGA score of 0 or 1 and 2 points from baseline
timeFrame: up to 52 weeks
measure: Proproportion of subjects with a 2 points from baseline at each iGA
timeFrame: up to 52 weeks
measure: Percentage of change and change from baseline in EASI per visit viewpoint
timeFrame: up to 52 weeks
measure: Percentage of subjects with weekly mean PP-NRS scores of 3 points from baseline
timeFrame: up to 52 weeks
measure: Percentage of change and change from baseline in the Skin Quality of Life Index Questionnaire (DLQI) score at each visit viewpoint
timeFrame: From the beginning of administration to the 52 week
measure: Percentage of change from baseline in eczema self-assessment (POEM) scores at each viewpoint
timeFrame: From the beginning of administration to the 52 week
measure: The time of SHR-1819 in the serum
timeFrame: From the beginning of administration to the 52th week
measure: The concentration of SHR-1819 in serum: AUC
timeFrame: From the beginning of administration to the 52th week
measure: Changes in the level of IgE in the serum
timeFrame: From the beginning of administration to the 52th week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Fudan University HuaShan Hospital
state: Shanghai
Study officials:
References: