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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Total Lesion Symptom Score (TLSS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
AQX-1125
1 x AQX-1125 Capsule daily
Intervention: AQX-1125 (Drug)
Placebo
1 x placebo capsule daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Total Lesion Symptom Score (TLSS)
Time Frame: 12 weeks
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 Outcomes
- Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score(12 weeks)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) Score(12 weeks)
- Change From Baseline in Investigator's Global Assessment (IGA)(12 weeks)
- Change From Baseline in Eczema Area and Severity Index (EASI) Score(12 weeks)