Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Recruiting · NCT06880276 · Interventional (participants receive a specific treatment) · Lead sponsor: Qilu Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
1.5% QLM3003 ointment2% QLM3003 ointmentQLM3003 Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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).
Where it is running
1 location listed.
- The First Affiliated Hospital of China Medical University - Shenyang, China