Clinical trial NCT02324972: Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Eczema
AD
AQX-1125
SHIP1
Lead sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Sponsor class: INDUSTRY
Collaborators: name: Innovaderm Research Inc.
First posted: 2014-12-24
Enrollment: 54
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Total Lesion Symptom Score (TLSS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Investigator's Global Assessment (IGA)
timeFrame: 12 weeks
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: 12 weeks
measure: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
timeFrame: 12 weeks
measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: AQX-Innovaderm site
state: Quebec
Study officials:
affiliation: Aquinox Pharamceuticals Inc
name: Maggie Wang, MD
role: STUDY_DIRECTOR
References: