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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06058000
Recruitment Status : Not yet recruiting
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Qilu Pharmaceutical Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: 1.5% QLM3003 Drug: 2% QLM3003 Drug: Vehicle (Placebo) Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: QLM3003 Low Dose
2% cream applied once daily (QD)
 Drug: 2% QLM3003
QLM3003 topical cream
Experimental: QLM3003 Middle Dose
1.5% cream applied twice daily (BID)
 Drug: 1.5% QLM3003
QLM3003 topical cream
Experimental: QLM3003 High Dose
2% cream applied twice daily (BID)
 Drug: 2% QLM3003
QLM3003 topical cream
Placebo Comparator: Placebo Comparator: Vehicle
Vehicle cream applied twice daily (BID)
 Drug: Vehicle (Placebo)
Vehicle topical cream
Placebo Comparator: High Placebo Comparator: Vehicle
Vehicle cream applied twice daily (BID)
 Drug: Vehicle (Placebo)
Vehicle topical cream


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8 [ Time Frame: Baseline, 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 :
  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 [ Time Frame: Baseline, Weeks 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06058000


Contacts
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Contact: Mingxia Lv, Master 13256161060 mingxia.lv@qilu-pharma.com
Contact: Xinghua Gao, Doctor 024-83283391 gaobarry@hotmail.com

Locations
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China, Liaoning
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Contact: Xinghua Gao, Doctor    024-83283391    gaobarry@hotmail.com   
China, Shandong
Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, China, 276000
Contact: Furen Zhang, Doctor    13608921718    zhangfuren@hotmail.com   
Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Xinghua Gao, Doctor First Hospital of China Medical University
Principal Investigator: Furen zhang, Doctor Dermatology Hospital of Shandong First Medical University
More Information
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Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT06058000    
Other Study ID Numbers: QLM3003-201
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases