NCT06884891

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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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®

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-05-01
• Completion: 2028-04-01
• First posted: 2025-03-19
• Last updated: 2025-03-21