A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis

NCT ID: NCT06058000

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2024-09-30

Brief Summary

The purpose of this study is to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.

Detailed Description

This study is a Phase 2, randomized, double-blind,placebo controlled, parallel group study to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

QLM3003 Low Dose

2% cream applied once daily (QD)

Group Type: EXPERIMENTAL

2% QLM3003

Intervention Type: DRUG

QLM3003 topical cream

QLM3003 Middle Dose

1.5% cream applied twice daily (BID)

Group Type: EXPERIMENTAL

1.5% QLM3003

Intervention Type: DRUG

QLM3003 topical cream

QLM3003 High Dose

2% cream applied twice daily (BID)

Group Type: EXPERIMENTAL

2% QLM3003

Intervention Type: DRUG

QLM3003 topical cream

Placebo Comparator: Vehicle

Vehicle cream applied twice daily (BID)

Group Type: PLACEBO_COMPARATOR

Vehicle (Placebo)

Intervention Type: DRUG

Vehicle topical cream

High Placebo Comparator: Vehicle

Vehicle cream applied twice daily (BID)

Group Type: PLACEBO_COMPARATOR

Vehicle (Placebo)

Intervention Type: DRUG

Vehicle topical cream

Interventions

1.5% QLM3003

QLM3003 topical cream

Intervention Type: DRUG

2% QLM3003

QLM3003 topical cream

Intervention Type: DRUG

Vehicle (Placebo)

Vehicle topical cream

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.
• Ages at ≥18 and ≤ 65 years.
• The diagnosis of atopic dermatitis will be confirmed according to the criteria of Hanifin and Rajka at the Screening Visit and Have a clinical diagnosis of atopic dermatitis for at least 6 months.
• Have an Investigator's Global Assessment (IGA) score of 2, or3 at screening and at baseline.
• Have atopic dermatitis on the head (excluding hair-bearing scalp), neck, trunk, or limbs, covering at least 2% of total BSA and up to and including 20% of total BSA at Screening and at baseline.

Exclusion Criteria

• Subjects with other dermatologic disease besides AD whose presence or treatments could interfere the assessment of disease (eg, psoriasis).
• In the opinion of the investigator, have any clinically significant laboratory abnormality that would affect the participant's participation in the study.
• Use of topical treatments for AD within 2 weeks of baseline.
• Vaccinated or exposed to a live or attenuated vaccine within the 12 weeks of baseline, or is expected to be vaccinated these vaccines during treatment.
• A history of alcohol or substance abuse within 12 months prior to Screening that in the opinion of the investigator will preclude participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinghua Gao, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Furen zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Dermatology Hospital of Shandong First Medical University

Locations

The First Hospital of China Medical University

Shenyang, Liaoning, China

Dermatology Hospital of Shandong First Medical University

Jinan, Shandong, China

Countries

China

Other Identifiers

QLM3003-201

Identifier Type: -

Identifier Source: org_study_id