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NCT Number: NCT06884891

A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

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®

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QL2108 injection

Drug

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

Dupixent®

Drug

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 outcomes

  1. Proportion of patients achieving EASI-75 at week 16.

    Time frame: 16 weeks

    EASI-75

Secondary outcomes

  1. Proportion of patients achieving EASI-75 at week 52

    Time frame: 52 weeks

    EASI-75

  2. 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

    IGA-TS

Study contacts

Contact information is provided by the study sponsor or research team.

Mengli Jiang

CONTACT

[email protected]

+086-15866209831

Wangwang zhi, Project Manager

CONTACT

[email protected]

+086-17761716313

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 19, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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