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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.