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Not yet recruitingNCT06884891Updated Mar 21, 2025

A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

A Phase 3 interventional study of QL2108 injection and Dupixent® in Atopic Dermatitis, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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®

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic Dermatitis
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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
520 participants (estimated)

Study arms

  • Experimental
    QL2108 injection

    QL2108 injection; 300mg/2.0mL; subcutaneous injection

    Drug: QL2108 injection

  • Active comparator
    Dupixent®

    Dupixent®; 300mg/2.0mL; subcutaneous injection

    Drug: Dupixent®

Interventions

  • DrugQL2108 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

  • DrugDupixent®

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

05

What researchers measure

Primary outcomes

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

    EASI-75

    Time frame: 16 weeks

Secondary outcomes

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

    EASI-75

    Time frame: 52 weeks

  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

    IGA-TS

    Time frame: 16 weeks and 52 weeks

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Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06884891
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 19, 2025
Start date
Apr 2025 (estimated)
Primary completion
May 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Mar 21, 2025

Study contacts

Wangwang zhi, Project Manager
Contact
wangwang.zhi@qilu-pharma.com
+086-17761716313
Mengli Jiang
Contact
mengli.jiang@qilu-pharma.com
+086-15866209831

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Qilu Pharmaceutical Co., Ltd.

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