NCT02324972

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Aquinox Pharmaceuticals (Canada) Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	AQX-1125	Synthetic SHIP1 activator
DRUG	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2014-12-24
• Last updated: 2018-10-05
• Results posted: 2018-10-05

Locations

1 site across 1 country: Canada