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.

Official 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®

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 75 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 520 participants

Study Arms

• QL2108 injection (EXPERIMENTAL)
  QL2108 injection; 300mg/2.0mL; subcutaneous injection
• Dupixent® (ACTIVE_COMPARATOR)
  Dupixent®; 300mg/2.0mL; subcutaneous injection

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 Outcomes

• Proportion of patients achieving EASI-75 at week 16. (16 weeks)

Secondary Outcomes

• Proportion of patients achieving EASI-75 at week 52 (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 (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.

Contact Information

• Wangwang zhi, Project Manager — CONTACT
  Phone: +086-17761716313
  Email: wangwang.zhi@qilu-pharma.com
• Mengli Jiang — CONTACT
  Phone: +086-15866209831
  Email: mengli.jiang@qilu-pharma.com

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