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

Primary Purpose

Atopic Dermatitis

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
1.5% QLM3003
2% QLM3003
Vehicle (Placebo)
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Hospital of China Medical University
  • Dermatology Hospital of Shandong First Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

QLM3003 Low Dose

QLM3003 Middle Dose

QLM3003 High Dose

Placebo Comparator: Vehicle

High Placebo Comparator: Vehicle

Arm Description

2% cream applied once daily (QD)

1.5% cream applied twice daily (BID)

2% cream applied twice daily (BID)

Vehicle cream applied twice daily (BID)

Vehicle cream applied twice daily (BID)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.

Full Information

First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06058000
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLM3003 Low Dose
Arm Type
Experimental
Arm Description
2% cream applied once daily (QD)
Arm Title
QLM3003 Middle Dose
Arm Type
Experimental
Arm Description
1.5% cream applied twice daily (BID)
Arm Title
QLM3003 High Dose
Arm Type
Experimental
Arm Description
2% cream applied twice daily (BID)
Arm Title
Placebo Comparator: Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cream applied twice daily (BID)
Arm Title
High Placebo Comparator: Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cream applied twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
1.5% QLM3003
Intervention Description
QLM3003 topical cream
Intervention Type
Drug
Intervention Name(s)
2% QLM3003
Intervention Description
QLM3003 topical cream
Intervention Type
Drug
Intervention Name(s)
Vehicle (Placebo)
Intervention Description
Vehicle topical cream
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8
Description
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.
Time Frame
Baseline, Weeks 8
Secondary Outcome Measure Information:
Title
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
Description
IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Time Frame
Baseline, Weeks 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingxia Lv, Master
Phone
13256161060
Email
mingxia.lv@qilu-pharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghua Gao, Doctor
Phone
024-83283391
Email
gaobarry@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinghua Gao, Doctor
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Furen zhang, Doctor
Organizational Affiliation
Dermatology Hospital of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinghua Gao, Doctor
Phone
024-83283391
Email
gaobarry@hotmail.com
Facility Name
Dermatology Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furen Zhang, Doctor
Phone
13608921718
Email
zhangfuren@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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