Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT06468956
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Moderate to Severe Atopic Dermatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1819 — DRUG
    SHR-1819 injection
  • Placebo — DRUG
    placebo

Study Details

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

Key Dates

Start date
Jun 14, 2024
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
652 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1819 injection dose 1
  • Experimental: SHR-1819 injection dose 2
  • Placebo Comparator: placebo

Primary Outcome Measure

At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline) [ Time Frame: up to 16 weeks ]

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