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RECRUITING
NCT06880276
PHASE3

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2025-05-16

Completion Date

2027-05

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

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)

Locations (1)

The First Affiliated Hospital of China Medical University

Shenyang, China