NCT02324972

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2018

Completed
Last Updated

October 5, 2018

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

December 19, 2014

Results QC Date

May 8, 2017

Last Update Submit

December 8, 2017

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisEczemaADAQX-1125SHIP1

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (4)

  • Change From Baseline in Investigator's Global Assessment (IGA)

    12 weeks

  • Change From Baseline in Eczema Area and Severity Index (EASI) Score

    12 weeks

  • Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score

    12 weeks

  • Change From Baseline in Patient Oriented Eczema Measure (POEM) Score

    12 weeks

Study Arms (2)

AQX-1125

EXPERIMENTAL

1 x AQX-1125 Capsule daily

Drug: AQX-1125

Placebo

PLACEBO COMPARATOR

1 x placebo capsule daily

Drug: Placebo

Interventions

AQX-1125DRUG

Synthetic SHIP1 activator

AQX-1125
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Female subject who is pregnant or breast-feeding
  • Unstable or clinically infected atopic dermatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AQX-Innovaderm site

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Clinical
Organization
Aquinox Pharmaceuticals (Canada) Inc.
clinical@aqxpharma.com
+1 604-629-9223

Study Officials

  • Maggie Wang, MD

    Aquinox Pharamceuticals Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

October 5, 2018

Results First Posted

October 5, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)