A Phase Ⅲ Comparative Study of QL2108 to Dupixent®

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Dupixent®; Drug: QL2108 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06884891

QL2108-301

Details and patient eligibility

About

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®

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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520 participants in 2 patient groups

QL2108 injection

Experimental group

Description:

QL2108 injection; 300mg/2.0mL; subcutaneous injection

Treatment:

Drug: QL2108 injection

Dupixent®

Active Comparator group

Description:

Dupixent®; 300mg/2.0mL; subcutaneous injection

Treatment:

Drug: Dupixent®