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Not yet recruiting NCT06884891

A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

Phase III Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QL2108 injection, Dupixent®.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter Randomized, Double-blinded, Parallel, Positive-controlled, Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of QL2108 to Dupixent® in Adult Subjects With Moderate-to-Severe Atopic Dermatitis.

Overview

It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase Ⅲ comparative study to evaluate the efficacy and safety of QL2108 to Dupixent® in adult subjects with moderate-to-severe atopic dermatitis. A total of 520 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2108 injection or Dupixent®

Interventions

  • Drug QL2108 injection
    300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous injection
  • Drug Dupixent®
    300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W); subcutaneous injection

Primary outcome measures

  • Proportion of patients achieving EASI-75 at week 16. [Time frame: 16 weeks]
Secondary outcome measures (2)
  • Proportion of patients achieving EASI-75 at week 52 [Time frame: 52 weeks]
  • Proportion of patients achieving IGA-TS (IGA score was 0 or 1 and decreased by ≥2 points from baseline) at week 16 and week 52 [Time frame: 16 weeks and 52 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06884891 · QL2108-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗