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

RecruitingPhase 3Ages 18 Years - 75 YearsAllQilu Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

  • 1.5% QLM3003 ointment
  • 2% QLM3003 ointment
  • QLM3003 Placebo
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Where

1 site
The First Affiliated Hospital of China Medical University
Shenyang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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