NCT02324972: KINSHIP

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

Completed Phase 2 Results posted Last updated 8 December 2017

What this trial tests

Phase 2 trial testing AQX-1125 in Atopic Dermatitis in 54 participants. Completed in 1 December 2015.

Timeline

1 December 2014

Primary endpoint
1 November 2015

1 December 2015

Quick facts

Lead sponsor	Aquinox Pharmaceuticals (Canada) Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	54
Start date	1 December 2014
Primary completion	1 November 2015
Estimated completion	1 December 2015
Sites	1 location across Canada

Drugs / interventions tested

• AQX-1125 — full drug profile →
• Placebo

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Aquinox Pharmaceuticals (Canada) Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. PI3K inhibitors in inflammation, autoimmunity and cancer.
   Stark AK, Sriskantharajah S, Hessel EM, Hessel EM, et al · · 2015 · cited 236× · PMID 26093105 · DOI 10.1016/j.coph.2015.05.017
2. Skin-Associated B Cells in the Pathogenesis of Cutaneous Autoimmune Diseases-Implications for Therapeutic Approaches.
   Fetter T, Niebel D, Braegelmann C, Wenzel J. · · 2020 · cited 43× · PMID 33297481 · DOI 10.3390/cells9122627
3. Systemic treatments for eczema: a network meta-analysis.
   Sawangjit R, Dilokthornsakul P, Lloyd-Lavery A, Lai NM, et al · · 2020 · cited 30× · PMID 32927498 · DOI 10.1002/14651858.cd013206.pub2
4. Looking forward to new targeted treatments for chronic spontaneous urticaria.
   Kocatürk E, Maurer M, Metz M, Grattan C. · · 2017 · cited 29× · PMID 28078079 · DOI 10.1186/s13601-016-0139-2
5. Targeting the FcεRI Pathway as a Potential Strategy to Prevent Food-Induced Anaphylaxis.
   Dispenza MC, Bochner BS, MacGlashan DW. · · 2020 · cited 25× · PMID 33391286 · DOI 10.3389/fimmu.2020.614402