NCT06477835

A Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- \< 18 years) and adults (18-75 years) with moderate to severe AD.

Detailed description

This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy and safety of SIM0718 in adolescents (12- \< 18 years) and adults (18-75 years) with moderate to severe AD. Subjects who meet entry criteria will be randomized to receive either SIM0718 or matching placebo.The study includes a screening period, a treatment period and a follow-up period.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	SIM0718 Injection	Subjects who meet entry criteria will be randomized in a 1:1 ratio to receive either SIM0718 or matching placebo,Q2W, SC until Week 16. At the Week 16 visit, subjects in the placebo group will be transferred to SIM0718 300 mg Q2W after completing safety and efficacy assessments. Subjects who were originally treated with 300 mg Q2W of SIM0718 will continue on their original treatment regimen.

Timeline

• Start date: 2024-07-04
• Primary completion: 2025-11-04
• Completion: 2025-12-23
• First posted: 2024-06-27
• Last updated: 2026-03-31

Locations

1 site across 1 country: China