MedTrace Logo

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

NCT06477835 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Simcere Pharmaceutical Co., Ltd

    lead OTHER

Principal Investigators

  • Jianzhong Zhang · Peking University People's Hospital

  • Cheng Zhou · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-04
Primary Completion
2025-11-04
Completion
2025-12-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06477835 on ClinicalTrials.gov