Clinical trial NCT06058000: A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8
timeFrame: Baseline, Weeks 8
Secondary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 8
timeFrame: Baseline, Weeks 8
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Dermatology Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: First Hospital of China Medical University
name: Xinghua Gao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Hospital of Shandong First Medical University
name: Furen zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: