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NCT06884891Not yet recruitingPhase 3

A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

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.

Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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®

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
520 (estimated)
First submitted
13 Mar 2025
Start date
Apr 2025
Primary completion date
May 2027
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
NCT number
NCT06884891

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 520
  • From Apr 2025 to the primary completion date, May 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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%.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.