Trial · NCT02324972
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
NCT02324972, Phase 2, Completed, Aquinox Pharmaceuticals (Canada) Inc.; results first posted 2018-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis. Trials, record NCT02324972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02324972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
- NCT number
- NCT02324972
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Conditions
- Atopic Dermatitis
- Interventions
- AQX-1125, Placebo
- First posted
- 2014-12-24
- Last updated
- 2018-10-05
- Results first posted
- 2018-10-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Lesion Symptom Score (TLSS) | 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 | Change From Baseline in Investigator's Global Assessment (IGA) | 12 weeks | The IGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe). |
| Secondary | Change From Baseline in Eczema Area and Severity Index (EASI) Score | 12 weeks | The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's atopic dermatitis based on both lesion severity and the percentage of body surface area (BSA) affected. Lesions are assessed on four domains; 1) erythema, 2) induration/papulation, 3) excoriation and 4) lichenification. Each domain is scored separately over four body regions (head/neck, upper limbs, trunk and lower limbs) on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate and 3 = severe) with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region relative to the whole body. The sum of these scores provides the EASI total score, ranging from 0 to 72 with a higher score indicating greater severity of atopic dermatitis. |
| Secondary | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | 12 weeks | The severity scoring of atopic dermatitis (SCORAD) index is a standard tool to assess the atopic dermatitis (AD) severity in clinical studies. Six items; erythema, edema/papulation, oozing/crusts, excoriation, lichenification and dryness are measured on a scale from 0-3 for a total of 18 points, with a higher score indicating greater severity. The percentage of BSA affected by AD is evaluated (percentage divided by 5) and added to the total SCORAD score. Loss of sleep and pruritus are also evaluated by subjects on a visual analog scale (scores ranging from 0-10) with a higher score indicating greater severity. The sum of these measures represents the SCORAD which ranges from 0 (absent disease) to 103 (severe disease). |
| Secondary | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | 12 weeks | The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Lesion Symptom Score (TLSS) | 12 weeks | The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Investigator's Global Assessment (IGA) | 12 weeks | The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Eczema Area and Severity Index (EASI) Score | 12 weeks | The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score | 12 weeks | The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | 12 weeks | The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Lesion Symptom Score (TLSS) | AQX-1125 | Baseline | 6.3 | Standard Deviation 1.16 | units on a scale |
| Change From Baseline in Total Lesion Symptom Score (TLSS) | Placebo | Baseline | 6.6 | Standard Deviation 1.31 | units on a scale |
| Change From Baseline in Total Lesion Symptom Score (TLSS) | AQX-1125 | Week 12 (Change from baseline) | -1.9 | Standard Deviation 2.19 | units on a scale |
| Change From Baseline in Total Lesion Symptom Score (TLSS) | Placebo | Week 12 (Change from baseline) | -1.9 | Standard Deviation 2.41 | units on a scale |
| Change From Baseline in Investigator's Global Assessment (IGA) | AQX-1125 | Baseline | 2.6 | Standard Deviation 0.50 | units on a scale |
| Change From Baseline in Investigator's Global Assessment (IGA) | Placebo | Baseline | 2.8 | Standard Deviation 0.52 | units on a scale |
| Change From Baseline in Investigator's Global Assessment (IGA) | AQX-1125 | Week 12 (Change from baseline) | -0.7 | Standard Deviation 0.98 | units on a scale |
| Change From Baseline in Investigator's Global Assessment (IGA) | Placebo | Week 12 (Change from baseline) | -0.8 | Standard Deviation 0.87 | units on a scale |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | AQX-1125 | Baseline | 5.58 | Standard Deviation 3.34 | units on a scale |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | Placebo | Baseline | 5.35 | Standard Deviation 2.24 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AQX-1125 | 26 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | COMPLETED | AQX-1125 | 19 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | AQX-1125 | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | AQX-1125 | 4 | 26 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | AQX-1125 | 2 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 28 | |
| other | Abdominal Pain | Gastrointestinal disorders | AQX-1125 | 2 | 26 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 28 | |
| other | Dyspepsia | Gastrointestinal disorders | AQX-1125 | 2 | 26 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 28 | |
| other | Nasopharyngitis | Infections and infestations | AQX-1125 | 6 | 26 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 28 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AQX-1125 | 0 | 26 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | AQX-1125 | 17 | 26 |
| Total, other adverse events | Placebo | 14 | 28 |
| Total, serious adverse events | AQX-1125 | 0 | 26 |
| Total, serious adverse events | Placebo | 0 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AQX-1125 vs Placebo: deaths from any cause | Trial comparisons |
| AQX-1125 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02324972
GET https://conductscience.org/api/trials/v1/NCT02324972/registered