A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

Launched by QILU PHARMACEUTICAL CO., LTD. · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QL2108 for adults with moderate-to-severe atopic dermatitis, a skin condition that causes itchy and inflamed skin. The goal is to compare how well QL2108 works and how safe it is compared to a well-known medication called Dupixent®. The trial will involve 520 participants who will be randomly assigned to receive either QL2108 or Dupixent®.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of atopic dermatitis for at least a year. They should also have a specific level of severity in their skin condition, as measured by certain scores. It's important to note that people who have previously used similar treatments or participated in other clinical trials recently may not be able to join. If you decide to participate, you will receive either the new treatment or Dupixent®, and your progress will be closely monitored throughout the study to ensure safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects aged from 18 to 75 years (including the boundary value)
• • At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history of ≥1 year prior to screening.
• • During the screening period and prior to randomization: EASI score ≥16, IGA score ≥3, BSA ≥10%.
• Exclusion Criteria:
• • People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
• • Having participated in drug or device clinical trials within 12 weeks or 5 half-lives of other investigational drugs before the study administration.
• • Subjects who have received live vaccines or live-attenuated vaccines within 12 weeks prior to randomization or plan to receive such vaccines during the trial period.