Psoriasis VulgarisNEUTROPRONCT04750161
The Role Of Neutrophil Proteases As Global Regulators Of Il-1 Family Cytokine Activity In Skin Disorders
An observational study of Psoriasis Vulgaris and Atopic Dermatitis, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial summary
Pro-inflammatory cytokines are critically important drivers of inflammatory and autoimmune diseases and cytokine-targeted biologics have been transformative in the treatment of several inflammatory and autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris, Atopic Dermatitis, Ichthyosis Vulgaris
- How many people
- 80 participants
- Where
- 1 siteIreland
- Study dates
- 2 Mar 2021to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A mix of participants from all ages and genders, 20 from each inflammatory skin disorders: psoriasis, atopic dermatitis and ichthyosis vulgaris as well as 20 healthy controls.
Who may be able to join
- Have psoriasis, atopic Dermatitis or ichthyosis vulgaris with visible skin lesions, preferably on the forearm which are amenable to sampling.
- Healthy control group without any skin disease.
Who cannot join
- Under 18 years old
- Fully treated skin disease without active lesions
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Clinical Research Facility, St James Hospital
Dublin
Matthew Coalter, 0858351212, coalterm@tcd.ie
About this study
Pro-inflammatory cytokines are critically important drivers of inflammatory and autoimmune diseases and cytokine-targeted biologics have been transformative in the treatment of several inflammatory and autoimmune diseases. As the diversity of approved cytokine-targeted biologic therapies grows, it will become increasingly important to stratify patients on the basis of specific genetic or disease biomarker phenotypes to ensure that patients receive the appropriate cytokine-targeted biologic, at the appropriate dose, and at the appropriate time. This project aims to explore patterns of pro-inflammatory cytokine/chemokine expression within normal versus (i) psoriatic, (ii) eczematic, (iii) ichthyotic human skin, as well as in human and mouse models of skin inflammation, with the objective of identifying cytokine response profiles ('cytokine fingerprints') that will provide a molecular basis for (a) the stratification of patients into disease subtypes that (b) enable cytokine-directed biologics to be targeted towards patients that are most likely to benefit from them. The investigators anticipate that 'cytokine fingerprinting' will aid in the selection of the most appropriate biologics in patients that are most likely to benefit from such therapies.
Read the detailed description
Neutrophils, the 'first responder' cells of the immune system are recruited rapidly to sites of infection or inflammation. Neutrophil granule proteases, cathepsin G, elastase and proteinase-3, are thought to function as anti-microbial effectors, cooperatively working to kill microorganisms during infection. However, evidence also suggests that these enzymes play an important role in the coordination and escalation of inflammatory reactions, but how this is achieved has remained obscure. IL-1 family cytokines are important initiators of inflammation but require processing by enzymes for activation. The IL-1 cytokine family is made up of 11 members, but this study will focus on the processing and activation of 7 of these pro-inflammatory cytokines (IL-1a, IL-1b, IL-18, IL-33, IL-36a, IL-36b and IL-36g). Members of the extended IL-1 family are found at high levels in barrier surfaces such as the skin, and thought to play a role in conditions such as psoriasis, atopic dermatitis/eczema and ichthyosis. Psoriasis particularly is associated with massive neutrophil influx. This study aims to investigate the physiological relevance of neutrophil proteases in the activation of IL-1 family cytokines in skin disorders.
The investigators plan to study the contribution of neutrophil proteases to inflammation in normal skin versus lesions from areas of skin affected by the conditions described above. The investigators are interested in measuring the levels of active neutrophil proteases in normal healthy skin versus skin lesions from affected sites compared to non-lesional, unaffected skin. The investigators also are interested to see if levels of neutrophil proteases found in lesions from affected skin sites are able to process and activate IL-1 family cytokines and contribute to inflammation in this way.
The investigators plan to include up to 80 participants; 20 healthy volunteers, 20 participants who will have a diagnosis of psoriasis, 20 participants who have a diagnosis of atopic dermatitis and 20 patients who have a diagnosis of ichthyosis with active lesions on their arms. Skin samples from normal versus lesional and non-lesional, unaffected skin will be taken by tape stripping method.
- Conditions
- Psoriasis Vulgaris, Atopic Dermatitis, Ichthyosis Vulgaris
- Being tested
- No intervention
- Medical subject headings
- Dermatitis, Atopic, Ichthyosis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be given to participants. It is purely observational.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis Vulgaris | Not described Receives: Other: No intervention | |
| Atopic Dermatitis | Not described Receives: Other: No intervention | |
| Ichthyosis Vulgaris | Not described Receives: Other: No intervention | |
| Healthy Controls | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine Profiles
The generation of a large dataset of cytokine profiles from uninvolved versus involved areas of skin from approximately 80 patients displaying heterogenous clinical symptoms.
Measured: 6 months
Secondary outcomes (1)
Develop sampling techniques
To develop practical and minimally invasive ways of generating 'cytokine fingerprints' using tape-stripped skin samples from psoriasis patients, with the ultimate goal of developing such tests into companion diagnostics.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start2 Mar 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Science Foundation Ireland, University of Dublin, Trinity College
- Responsible party
- Principal investigator, Matthew Coalter, St. James's Hospital, Ireland
- Investigators
- Alan Irvine, Principal investigator, St. James Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750161
- Sponsor's protocol ID
- CRFSJ0133
- Acronym
- NEUTROPRO
- Status last verified
- Mar 2021
- First submitted
- 6 Feb 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Neutrophil Proteases As Global Regulators Of Il-1 Family Cytokine Activity In Skin Disorders
- ClinicalTrials.gov ID
- NCT04750161
- Acronym / sponsor ID
- NEUTROPRO / CRFSJ0133
- Conditions
- Psoriasis Vulgaris, Atopic Dermatitis, Ichthyosis Vulgaris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Collaborators
- Science Foundation Ireland, University of Dublin, Trinity College
- Study start
- 2 Mar 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pro-inflammatory cytokines are critically important drivers of inflammatory and autoimmune diseases and cytokine-targeted biologics have been transformative in the treatment of several inflammatory and autoimmune diseases. As the diversity of approved cytokine-targeted biologic therapies grows, it will become increasingly important to stratify patients on the basis of specific genetic or disease biomarker phenotypes to ensure that patients receive the appropriate cytokine-targeted biologic, at the appropriate dose, and at the appropriate time. This project aims to explore patterns of pro-inflammatory cytokine/chemokine expression within normal versus (i) psoriatic, (ii) eczematic, (iii) ichthyotic human skin, as well as in human and mouse models of skin inflammation, with the objective of identifying cytokine response profiles ('cytokine fingerprints') that will provide a molecular basis for (a) the stratification of patients into disease subtypes that (b) enable cytokine-directed biologics to be targeted towards patients that are most likely to benefit from them. The investigators anticipate that 'cytokine fingerprinting' will aid in the selection of the most appropriate biologics in patients that are most likely to benefit from such therapies.
Detailed description
Neutrophils, the 'first responder' cells of the immune system are recruited rapidly to sites of infection or inflammation. Neutrophil granule proteases, cathepsin G, elastase and proteinase-3, are thought to function as anti-microbial effectors, cooperatively working to kill microorganisms during infection. However, evidence also suggests that these enzymes play an important role in the coordination and escalation of inflammatory reactions, but how this is achieved has remained obscure. IL-1 family cytokines are important initiators of inflammation but require processing by enzymes for activation. The IL-1 cytokine family is made up of 11 members, but this study will focus on the processing and activation of 7 of these pro-inflammatory cytokines (IL-1a, IL-1b, IL-18, IL-33, IL-36a, IL-36b and IL-36g). Members of the extended IL-1 family are found at high levels in barrier surfaces such as the skin, and thought to play a role in conditions such as psoriasis, atopic dermatitis/eczema and ichthyosis. Psoriasis particularly is associated with massive neutrophil influx. This study aims to investigate the physiological relevance of neutrophil proteases in the activation of IL-1 family cytokines in skin disorders.
The investigators plan to study the contribution of neutrophil proteases to inflammation in normal skin versus lesions from areas of skin affected by the conditions described above. The investigators are interested in measuring the levels of active neutrophil proteases in normal healthy skin versus skin lesions from affected sites compared to non-lesional, unaffected skin. The investigators also are interested to see if levels of neutrophil proteases found in lesions from affected skin sites are able to process and activate IL-1 family cytokines and contribute to inflammation in this way.
The investigators plan to include up to 80 participants; 20 healthy volunteers, 20 participants who will have a diagnosis of psoriasis, 20 participants who have a diagnosis of atopic dermatitis and 20 patients who have a diagnosis of ichthyosis with active lesions on their arms. Skin samples from normal versus lesional and non-lesional, unaffected skin will be taken by tape stripping method.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psoriasis Vulgaris | – | Other: No intervention |
| Atopic Dermatitis | – | Other: No intervention |
| Ichthyosis Vulgaris | – | Other: No intervention |
| Healthy Controls | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A mix of participants from all ages and genders, 20 from each inflammatory skin disorders: psoriasis, atopic dermatitis and ichthyosis vulgaris as well as 20 healthy controls.
Key inclusion criteria (2 listed)
- Have psoriasis, atopic Dermatitis or ichthyosis vulgaris with visible skin lesions, preferably on the forearm which are amenable to sampling.
- Healthy control group without any skin disease.
Key exclusion criteria (2 listed)
- Under 18 years old
- Fully treated skin disease without active lesions
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 |
|---|---|---|
| No interventionNo intervention will be given to participants. It is purely observational. | Other | Atopic Dermatitis, Healthy Controls, Ichthyosis Vulgaris, Psoriasis Vulgaris |
Primary outcome
Cytokine Profiles
Time frame: 6 months
The generation of a large dataset of cytokine profiles from uninvolved versus involved areas of skin from approximately 80 patients displaying heterogenous clinical symptoms.
1 secondary outcome
Develop sampling techniques
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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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.
Alan Irvine principal investigator
St. James Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris and Atopic Dermatitis, run by St. James's Hospital, Ireland at 1 site in Ireland.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Mar 2021. 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 Ireland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Coalter, MB BCh BAO MSc (0858351212, coalterm@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine Profiles (time frame: 6 months). 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 Mar 2021.