QLM3003 ointment for adults with mild to moderate atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial enrolling approximately 360 adults with mild to moderate atopic dermatitis. Participants are randomized 1:1:1 to receive 1.5% QLM3003 ointment, 2% QLM3003 ointment, or placebo applied twice daily for 8 weeks, with the primary efficacy endpoint of EASI 75 at week 8 and a key secondary endpoint of IGA-TS. Eligible patients are adults aged 18–75 with a history of AD of at least one year, an IGA score of 2 or 3, and 3–20% body surface area involvement. Safety and tolerability are monitored throughout the study with scheduled clinic visits and adverse event reporting.

Why it matters

Who can join: the full rules

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's running

• The First Affiliated Hospital of China Medical University
  Shenyang, China Recruiting

Study contacts

• Study coordinator: Mingxia Lv, Master
• Email: mingxia.lv@gilu-pharma.com
• Phone: 13256161060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.