Clinical Trial

A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated September 23, 2025 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-09; most recent amendment 2025-09-18.
Trial Details
NCT Number NCT07175233
Lead Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions Atopic Dermatitis (AD)
Enrollment 184 participants
Start Date 2025-10-27
Primary Completion 2026-08-15 (estimated)
Study Completion 2027-08-20 (estimated)
Updated on ClinicalTrials.gov 2025-09-23