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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1.5% QLM3003 ointment

QLM3003 ointment; 1.5%

Group Type EXPERIMENTAL

1.5% QLM3003 ointment

Intervention Type DRUG

QLM3003 topical cream; 1.5% cream applied twice daily (BID)

2% QLM3003 ointment

QLM3003 ointment; 2%

Group Type EXPERIMENTAL

2% QLM3003 ointment

Intervention Type DRUG

QLM3003 topical cream; 2% cream applied twice daily (BID)

Placebo

Vehicle

Group Type PLACEBO_COMPARATOR

QLM3003 Placebo

Intervention Type DRUG

vehicle; vehicle applied twice daily (BID)

Interventions

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1.5% QLM3003 ointment

QLM3003 topical cream; 1.5% cream applied twice daily (BID)

Intervention Type DRUG

2% QLM3003 ointment

QLM3003 topical cream; 2% cream applied twice daily (BID)

Intervention Type DRUG

QLM3003 Placebo

vehicle; vehicle applied twice daily (BID)

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No