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

Qilu Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle (Placebo); Drug: 1.5% QLM3003; Drug: 2% QLM3003

Study type: Interventional

Funder types: Industry

Identifiers

NCT06058000

QLM3003-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 5 patient groups, including a placebo group

QLM3003 Low Dose

Experimental group

Description:

2% cream applied once daily (QD)

Treatment:

Drug: 2% QLM3003

QLM3003 Middle Dose

Experimental group

Description:

1.5% cream applied twice daily (BID)

Treatment:

Drug: 1.5% QLM3003

QLM3003 High Dose

Experimental group

Description:

2% cream applied twice daily (BID)

Treatment:

Drug: 2% QLM3003

Placebo Comparator: Vehicle

Placebo Comparator group

Description:

Vehicle cream applied twice daily (BID)

Treatment:

Drug: Vehicle (Placebo)

High Placebo Comparator: Vehicle

Placebo Comparator group

Description:

Vehicle cream applied twice daily (BID)

Treatment:

Drug: Vehicle (Placebo)