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A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult patients (18-75 years) with moderate to severe AD suitable for systemic therapy. Approximately 184 subjects with moderate to severe AD are planned to be randomized in a 1: 1: 1: 1 ratio to SIM0278 low dose, SIM0278 medium dose, SIM0278 high dose, or placebo. Subjects were stratified at randomization by baseline disease severity (moderate \[IGA = 3\] VS severe \[IGA = 4\]). The study consisted of 4 phases: screening, double-blind induction, open-label maintenance, and safety follow-up.
Official title: A Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
184
Start Date
2025-10-27
Completion Date
2027-08-20
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
SIM0278 injection
SIM0278 injection
Placebo
placebo
Locations (2)
Affiliated Hangzhou First People's Hospital, School of Medicine , West Lake University
Hangzhou, China
The First Hospital of China Medical University
Shenyang, China