Clinical trial NCT06880276: Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
Study officials:
affiliation: First Hospital of China Medical University
name: Xinghua Gao, Doctor
role: STUDY_DIRECTOR
affiliation: Dermatology Hospital of Shandong First Medical University
name: Furen zhang, Doctor
role: STUDY_DIRECTOR
References: