Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
NCT Number: NCT06468956
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Moderate to Severe Atopic Dermatitis
Interventions: DRUG: SHR-1819|DRUG: Placebo
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 650
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-03-31
Locations: Shanghai Fudan University HuaShan Hospital, Shanghai, Shanghai, 200040, China

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

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), The extent of area is assessed using the EASI scale, up to 16 weeks|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, The overall degree of improvement was assessed using the IGA scale, up to 16 week
Secondary Outcome Measures: The proportion of subjects whose weekly mean of the daily (PP-NRS) score decreased by 4 points from baseline at Week 16, Prtch improvement was assessed using the pruritus 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|Proportion of subjects reaching EASI-75 at other visit viewpoints, The extent of area is assessed using the EASI scale, up to 52 weeks|The proportion of subjects with IGA score of 0 or 1 and 2 points from baseline, The overall degree of improvement was assessed using the IGA scale, up to 52 weeks|Proproportion of subjects with a 2 points from baseline at each iGA, The overall degree of improvement was assessed using the IGA scale, up to 52 weeks|Percentage of change and change from baseline in EASI per visit viewpoint, The extent of area is assessed using the EASI scale, up to 52 weeks|Percentage of subjects with weekly mean PP-NRS scores of 3 points from baseline, Prtch improvement was assessed using the pruritus scale, up to 52 weeks|Percentage of change and change from baseline in the Skin Quality of Life Index Questionnaire (DLQI) score at each visit viewpoint, Subject quality of life was assessed using the DLQI scale, From the beginning of administration to the 52 week|Percentage of change from baseline in eczema self-assessment (POEM) scores at each viewpoint, Subject quality of life was assessed using the POEM scale, From the beginning of administration to the 52 week|The time of SHR-1819 in the serum, The concentration of SHR-1819 in plasma will be determined, From the beginning of administration to the 52th 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 52th 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 52th week