Status:
RECRUITING
Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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) ...
Eligibility Criteria
Inclusion
- Male or female, 18-75 years old
- The diagnosis of atopic dermatitis (AD) during screening meets the Hanifin⁃Rajka standard, and the history of AD/ eczema ≥1 year before screening. All of the following conditions must be met during the screening and baseline periods:Number of participants with IGA score of "2" or "3".AD involving the head and neck (scalp excluded), trunk, and extremities, with a total affected BSA of 3-20% (inclusive)
Exclusion
- Subjects with comorbidities or other conditions that may interfere with the assessment of the investigational drug or the study disease, as determined by the investigator to be ineligible for participation
- Patients whose current AD disease status was assessed by the investigators to be unstable (spontaneous improvement or rapid deterioration) were not eligible to participate in the study.
- Patients who have received a marketed or investigational biologic for the treatment of AD, such as Dupilumab, within 3 months before baseline or within 5 half-lives of the drug (whichever was longer).
- Patients who had received systemic or topical JAK inhibitor therapy, including but not limited to Tofacitinib, Ruxolitinib, Upadacitinib, Baricitinib, Abrocitinib, Ivarmacitinib, and Gecacitinib, within 4 weeks before baseline or within 5 half-lives of the drug (whichever was longer).
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06880276
Start Date
May 16 2025
End Date
May 1 2027
Last Update
August 26 2025
Active Locations (1)
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1
The First Affiliated Hospital of China Medical University
Shenyang, China