A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

March 18, 2025 updated by: Qilu Pharmaceutical Co., Ltd.

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.

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®

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL2108 injection
QL2108 injection; 300mg/2.0mL; subcutaneous injection
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
Active Comparator: Dupixent®
Dupixent®; 300mg/2.0mL; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving EASI-75 at week 16.
Time Frame: 16 weeks
EASI-75
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving EASI-75 at week 52
Time Frame: 52 weeks
EASI-75
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
Time Frame: 16 weeks and 52 weeks
IGA-TS
16 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL2108-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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