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Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis (KINSHIP)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
AQX-1125
Placebo
Sponsored by
Aquinox Pharmaceuticals (Canada) Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Eczema, AD, AQX-1125, SHIP1

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female aged from 18 to 65 years old
  2. Confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria
  3. At least a 6 months history of atopic dermatitis.
  4. Body Surface Area (BSA) covered with atopic dermatitis of 1% or more
  5. Mild or moderate atopic dermatitis (IGA score of 2 or 3).
  6. TLSS of 5 or more at Day 0.
  7. Subject must use a non-medicated emollient daily for at least (≥) 7 days prior to Day 0 and should continue using that same emollient, at the same frequency, throughout the study.

Exclusion Criteria:

  1. Female subject who is pregnant or breast-feeding
  2. Unstable or clinically infected atopic dermatitis

Sites / Locations

  • AQX-Innovaderm site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AQX-1125

Placebo

Arm Description

1 x AQX-1125 Capsule daily

1 x placebo capsule daily

Outcomes

Primary Outcome Measures

Change From Baseline in Total Lesion Symptom Score (TLSS)
The TLSS is an assessment of the severity of each of the following three signs: erythema, papulation/infiltration, excoriation and lichenification. Each of these items are rated using a 4-point scale severity where 0 is clear, 1 = mild, 2= moderate and 3 = severe. These ratings are then added to create a total score ranging from 0 to 12

Secondary Outcome Measures

Change From Baseline in Investigator's Global Assessment (IGA)
The IGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe).
Change From Baseline in Eczema Area and Severity Index (EASI) Score
The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's atopic dermatitis based on both lesion severity and the percentage of body surface area (BSA) affected. Lesions are assessed on four domains; 1) erythema, 2) induration/papulation, 3) excoriation and 4) lichenification. Each domain is scored separately over four body regions (head/neck, upper limbs, trunk and lower limbs) on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate and 3 = severe) with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region relative to the whole body. The sum of these scores provides the EASI total score, ranging from 0 to 72 with a higher score indicating greater severity of atopic dermatitis.
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
The severity scoring of atopic dermatitis (SCORAD) index is a standard tool to assess the atopic dermatitis (AD) severity in clinical studies. Six items; erythema, edema/papulation, oozing/crusts, excoriation, lichenification and dryness are measured on a scale from 0-3 for a total of 18 points, with a higher score indicating greater severity. The percentage of BSA affected by AD is evaluated (percentage divided by 5) and added to the total SCORAD score. Loss of sleep and pruritus are also evaluated by subjects on a visual analog scale (scores ranging from 0-10) with a higher score indicating greater severity. The sum of these measures represents the SCORAD which ranges from 0 (absent disease) to 103 (severe disease).
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.

Full Information

First Posted
December 19, 2014
Last Updated
December 8, 2017
Sponsor
Aquinox Pharmaceuticals (Canada) Inc.
Collaborators
Innovaderm Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02324972
Brief Title
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
Acronym
KINSHIP
Official Title
The KINSHIP Trial: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Atopic Dermatitis by Targeting the SHIP1 Pathway
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aquinox Pharmaceuticals (Canada) Inc.
Collaborators
Innovaderm Research Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo on change from baseline in Total Lesion Symptom Score in subjects with mild to moderate atopic dermatitis
Detailed Description
One of the causative factors for the inflammatory response observed in AD is the release of chemokines and other chemoattractant factors followed by recruitment of inflammatory cell subtypes (10). IL-16, a Langerhans cells (LC)-derived chemoattractant cytokine for CD4+ cells, RANTES, monocyte chemotactic protein (MCP-4) and eotaxin are overexpressed in epidermal keratinocytes from AD subjects and may contribute to the chemotaxis of eosinophils, macrophages and Th2-lymphocytes (11). Since the activation of SHIP1 by AQX-1125 results in the inhibition of inflammatory cell chemotaxis and reduction of pro-inflammatory cytokine synthesis, this study hypothesized that AQX-1125 would improve AD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Eczema, AD, AQX-1125, SHIP1

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
AQX-1125
Arm Type
Experimental
Arm Description
1 x AQX-1125 Capsule daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 x placebo capsule daily
Intervention Type
Drug
Intervention Name(s)
AQX-1125
Intervention Description
Synthetic SHIP1 activator
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Total Lesion Symptom Score (TLSS)
Description
The TLSS is an assessment of the severity of each of the following three signs: erythema, papulation/infiltration, excoriation and lichenification. Each of these items are rated using a 4-point scale severity where 0 is clear, 1 = mild, 2= moderate and 3 = severe. These ratings are then added to create a total score ranging from 0 to 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Investigator's Global Assessment (IGA)
Description
The IGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe).
Time Frame
12 weeks
Title
Change From Baseline in Eczema Area and Severity Index (EASI) Score
Description
The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's atopic dermatitis based on both lesion severity and the percentage of body surface area (BSA) affected. Lesions are assessed on four domains; 1) erythema, 2) induration/papulation, 3) excoriation and 4) lichenification. Each domain is scored separately over four body regions (head/neck, upper limbs, trunk and lower limbs) on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate and 3 = severe) with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region relative to the whole body. The sum of these scores provides the EASI total score, ranging from 0 to 72 with a higher score indicating greater severity of atopic dermatitis.
Time Frame
12 weeks
Title
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Description
The severity scoring of atopic dermatitis (SCORAD) index is a standard tool to assess the atopic dermatitis (AD) severity in clinical studies. Six items; erythema, edema/papulation, oozing/crusts, excoriation, lichenification and dryness are measured on a scale from 0-3 for a total of 18 points, with a higher score indicating greater severity. The percentage of BSA affected by AD is evaluated (percentage divided by 5) and added to the total SCORAD score. Loss of sleep and pruritus are also evaluated by subjects on a visual analog scale (scores ranging from 0-10) with a higher score indicating greater severity. The sum of these measures represents the SCORAD which ranges from 0 (absent disease) to 103 (severe disease).
Time Frame
12 weeks
Title
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
Description
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.
Time Frame
12 weeks

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: Male or female aged from 18 to 65 years old Confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria At least a 6 months history of atopic dermatitis. Body Surface Area (BSA) covered with atopic dermatitis of 1% or more Mild or moderate atopic dermatitis (IGA score of 2 or 3). TLSS of 5 or more at Day 0. Subject must use a non-medicated emollient daily for at least (≥) 7 days prior to Day 0 and should continue using that same emollient, at the same frequency, throughout the study. Exclusion Criteria: Female subject who is pregnant or breast-feeding Unstable or clinically infected atopic dermatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie Wang, MD
Organizational Affiliation
Aquinox Pharamceuticals Inc
Official's Role
Study Director
Facility Information:
Facility Name
AQX-Innovaderm site
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis

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