Phase 2
N=54
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02324972 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Change From Baseline in Total Lesion Symptom Score (TLSS) — 6.3; 6.6; -1.9; -1.9 units on a scale — p=0.636
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AQX-1125 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Lesion Symptom Score (TLSS) |
6.3; 6.6; -1.9; -1.9 | 0.636 |
| SECONDARY Change From Baseline in Investigator's Global Assessment (IGA) |
2.6; 2.8; -0.7; -0.8 | 0.677 |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) Score |
5.58; 5.35; -2.84; -2.12 | 0.802 |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score |
36.19; 37.21; -12.06; -11.54 | 0.976 |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) Score |
16.7; 15.9; -5.6; -6.5 | 0.233 |
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
Eligibility Criteria
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 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.
Exclusion Criteria
- Female subject who is pregnant or breast-feeding
- Unstable or clinically infected atopic dermatitis
Data sourced from ClinicalTrials.gov (NCT02324972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.