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.
1 other identifier
interventional
520
0 countries
N/A
Brief 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®
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2025
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 21, 2025
March 1, 2025
2.1 years
March 13, 2025
March 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving EASI-75 at week 16.
EASI-75
16 weeks
Secondary Outcomes (2)
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
Study Arms (2)
QL2108 injection
EXPERIMENTALQL2108 injection; 300mg/2.0mL; subcutaneous injection
Dupixent®
ACTIVE COMPARATORDupixent®; 300mg/2.0mL; subcutaneous injection
Interventions
300mg/2.0mL; an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W);subcutaneous 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
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2025
First Posted
March 19, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
March 21, 2025
Record last verified: 2025-03