QLM3003 ointment for adults with mild to moderate atopic dermatitis

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

This trial will test whether applying QLM3003 ointment (1.5% or 2%) twice daily for 8 weeks helps adults with mild to moderate atopic dermatitis compared with a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: Dupilumab, Tofacitinib, Ruxolitinib, Upadacitinib, Baricitinib, Abrocitinib, Ivarmacitinib, Gecacitinib
• Locations: 1 site (Shenyang)
• Trial ID: NCT06880276 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with a diagnosis of atopic dermatitis per Hanifin-Rajka, disease duration of one year or more, an IGA score of 2 or 3, and 3–20% BSA affected are the ideal candidates.

Not a fit: Patients with severe or unstable atopic dermatitis, significant comorbidities that interfere with assessment, or recent use of biologic therapies are unlikely to receive benefit from this study.

Why it matters

Potential benefit: If successful, QLM3003 ointment could provide a new topical option to reduce inflammation and improve skin clearing in adults with mild to moderate atopic dermatitis.

How similar studies have performed: Other topical anti-inflammatory agents, including recent phase 3 topical JAK inhibitors, have shown benefit in mild to moderate atopic dermatitis, while QLM3003 itself represents a novel formulation being tested.

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).

Where this trial is running

Shenyang

• The First Affiliated Hospital of China Medical University — Shenyang, China (RECRUITING)

Study contacts

• Study coordinator: Mingxia Lv, Master

Conditions: Atopic Dermatitis