NCT06880276

Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess Efficacy and Safety of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (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-blind, placebo-controlled, parallel-group phase 3 clinical trial to evaluate the efficacy of QLM3003 ointment at week 8 based on the primary endpoint (EASI 75) and key secondary endpoint (IGA-TS).in patients with mild to moderate atopic dermatitis. A total of 360 patients with mild to moderate atopic dermatitis are planned to be included and randomized at a ratio of 1:1:1 to receive 1.5% QLM3003 ointment、2% QLM3003 ointment and placebo, twice a day.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	1.5% QLM3003 ointment	QLM3003 topical cream; 1.5% cream applied twice daily (BID)
DRUG	2% QLM3003 ointment	QLM3003 topical cream; 2% cream applied twice daily (BID)
DRUG	QLM3003 Placebo	vehicle; vehicle applied twice daily (BID)

Timeline

• Start date: 2025-05-16
• Primary completion: 2027-03-01
• Completion: 2027-05-01
• First posted: 2025-03-17
• Last updated: 2025-08-26

Locations

1 site across 1 country: China