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NOT YET RECRUITING
NCT07175233
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

SIM0278 injection

SIM0278 injection

OTHER

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