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

NCT06058000 | Completed Phase 2

• 1 other identifier: QLM3003-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8

  EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

  Baseline, Weeks 8

Secondary Outcomes (1)

• 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

  Baseline, Weeks 8

Study Arms (5)

QLM3003 Low Dose

EXPERIMENTAL

2% cream applied once daily (QD)

Drug: 2% QLM3003

QLM3003 Middle Dose

EXPERIMENTAL

1.5% cream applied twice daily (BID)

Drug: 1.5% QLM3003

QLM3003 High Dose

EXPERIMENTAL

2% cream applied twice daily (BID)

Drug: 2% QLM3003

Placebo Comparator: Vehicle

PLACEBO COMPARATOR

Vehicle cream applied twice daily (BID)

Drug: Vehicle (Placebo)

High Placebo Comparator: Vehicle

PLACEBO COMPARATOR

Vehicle cream applied twice daily (BID)

Drug: Vehicle (Placebo)

Interventions

1.5% QLM3003 DRUG

QLM3003 topical cream

QLM3003 Middle Dose

2% QLM3003 DRUG

QLM3003 topical cream

QLM3003 High Dose; QLM3003 Low Dose

Vehicle (Placebo) DRUG

Vehicle topical cream

High Placebo Comparator: Vehicle; Placebo Comparator: Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Dermatology Hospital of Shandong First Medical University

Jinan, Shandong, 276000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Xinghua Gao, Doctor

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• Furen zhang, Doctor

  Dermatology Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: November 13, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)