Atopic DermatitisPhase 2KINSHIPNCT02324972
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
A Phase 2 study testing AQX-1125 in people with Atopic Dermatitis, run by Aquinox Pharmaceuticals (Canada) Inc. at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- AQX-1125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Female subject who is pregnant or breast-feeding
- Unstable or clinically infected atopic dermatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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
- Being tested
- AQX-1125, Placebo
- Keywords
- Atopic dermatitis, Eczema, AD, AQX-1125, SHIP1
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQX-1125Drug
Synthetic SHIP1 activator
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AQX-1125 | Experimental | 1 x AQX-1125 Capsule daily Receives: Drug: AQX-1125 |
| Placebo | Placebo comparator | 1 x placebo capsule daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
Change From Baseline in Investigator's Global Assessment (IGA)
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).
Measured: 12 weeks
Change From Baseline in Eczema Area and Severity Index (EASI) Score
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.
Measured: 12 weeks
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
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).
Measured: 12 weeks
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Responsible party
- Sponsor
- Investigators
- Maggie Wang, MD, Study director, Aquinox Pharamceuticals Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324972
- Sponsor's protocol ID
- AQX-1125-204
- Acronym
- KINSHIP
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2014
- Last updated
- 5 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02324972
- Acronym / sponsor ID
- KINSHIP / AQX-1125-204
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Eczema, AD, AQX-1125, SHIP1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 5 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQX-1125 | Experimental | Drug: AQX-11251 x AQX-1125 Capsule daily |
| Placebo | Placebo comparator | Drug: Placebo1 x placebo capsule daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- Female subject who is pregnant or breast-feeding
- Unstable or clinically infected atopic dermatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQX-1125Synthetic SHIP1 activator | Drug | AQX-1125 |
| Placebo | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Change From Baseline in Investigator's Global Assessment (IGA)
Time frame: 12 weeks
Change From Baseline in Eczema Area and Severity Index (EASI) Score
Time frame: 12 weeks
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Time frame: 12 weeks
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie Wang, MD study director
Aquinox Pharamceuticals Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AQX-1125 in people with Atopic Dermatitis, run by Aquinox Pharmaceuticals (Canada) Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Lesion Symptom Score (TLSS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.