NCT07175233

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	SIM0278 injection	SIM0278 injection
OTHER	Placebo	placebo

Timeline

• Start date: 2025-10-27
• Primary completion: 2026-08-15
• Completion: 2027-08-20
• First posted: 2025-09-16
• Last updated: 2025-09-23

Locations

2 sites across 1 country: China