A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

Phase 3

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: QL2108 injection; Drug: Dupixent®

• Registration Number: NCT06884891
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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®

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-21
• Study Start: 2025-04
• Primary Completion: 2027-05
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL2108 injection	QL2108 injection	QL2108 injection; 300mg/2.0mL; subcutaneous injection
Dupixent®	Dupixent®	Dupixent®; 300mg/2.0mL; subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving EASI-75 at week 16.	16 weeks	EASI-75

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving EASI-75 at week 52	52 weeks	EASI-75
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	IGA-TS