Hidradenitis SuppurativaNCT04440410
Evaluation of Cutaneous and Circulating Inflammatory Biomarkers in Hidradenitis Suppurativa and Atopic Dermatitis
An observational study of Hidradenitis Suppurativa and Dermatitis, Atopic, run by Kymera Therapeutics, Inc. at 1 site in Canada.
Trial summary
This non-intervention study will identify the biomarker profiles in hidradenitis suppurativa (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in interventional studies evaluating efficacy during therapeutic intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa, Dermatitis, Atopic
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 28 May 2020to 24 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with active mild, moderate, or severe HS or active moderate or severe AD disease.
Who may be able to join
- Age 18 or older
- Active HS or AD disease, diagnosed by PI
- Patients with mild (HS only), moderate, or severe disease using the HS-PGA or PGA assessment.
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study.
Who cannot join
- Patient is currently on a biologic or other immunosuppressive treatment for HS or AD.
- Use of biologic treatment for HS or AD within 3 months or 5 half-lives, whichever is longer
- Use of non-biologic immunosuppressive treatment (eg. Cyclosporin) in the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
Canada1 site
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4C 9M7
About this study
Official title: Non-interventional Study to Evaluate Cutaneous and Circulating Inflammatory Biomarkers for a Novel IRAK4-targeted Therapeutic in Hidradenitis Suppurativa and Atopic Dermatitis Patient Samples
This non-intervention study will identify the biomarker profiles in hidradenitis suppurativa (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in interventional studies evaluating efficacy during therapeutic intervention. Study data will also be used to correlate cellular/molecular changes in blood (cells and serum), and tissue, with clinical/histopathological phenotypes.
Read the detailed description
This study is an exploratory correlative study in subjects with HS or AD. Blood samples and skin biopsies will be collected from all subjects and used to assess the following: cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples, correlations between cutaneous and circulating inflammatory biomarkers and disease severity, effects of IRAK4 degradation on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients.
De-identified routine clinical data that is collected will be correlated with the research findings.
- Conditions
- Hidradenitis Suppurativa, Dermatitis, Atopic
- Keywords
- IRAK4
- Medical subject headings
- Hidradenitis Suppurativa, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hidradenitis suppurativa | Subjects with active mild, moderate, or severe HS disease using the HS-PGA assessment | |
| Atopic Dermatitis | Subjects with active moderate or severe AD disease using the PGA assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Identification
Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples
Measured: Day 1
Determination of Biomarker Correlations
Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity
Measured: Day 1
Examination of IRAK4 Degradation Effects Ex Vivo
Examine effect of IRAK4 degrader on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start28 May 2020
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- York Dermatology Clinic and Research Centre
- Responsible party
- Sponsor
- Investigators
- Afsaneh Alavi, MD, Principal investigator, York Dermatology Clinic and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440410
- Sponsor's protocol ID
- YDC-2
- Status last verified
- Apr 2021
- First submitted
- 1 Jun 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Evaluate Cutaneous and Circulating Inflammatory Biomarkers for a Novel IRAK4-targeted Therapeutic in Hidradenitis Suppurativa and Atopic Dermatitis Patient Samples
- ClinicalTrials.gov ID
- NCT04440410
- Acronym / sponsor ID
- YDC-2
- Conditions
- Hidradenitis Suppurativa, Dermatitis, Atopic
- Keywords
- IRAK4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kymera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- York Dermatology Clinic and Research Centre
- Study start
- 28 May 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 19 Jun 2020 (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.
This non-intervention study will identify the biomarker profiles in hidradenitis suppurativa (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in interventional studies evaluating efficacy during therapeutic intervention. Study data will also be used to correlate cellular/molecular changes in blood (cells and serum), and tissue, with clinical/histopathological phenotypes.
Detailed description
This study is an exploratory correlative study in subjects with HS or AD. Blood samples and skin biopsies will be collected from all subjects and used to assess the following: cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples, correlations between cutaneous and circulating inflammatory biomarkers and disease severity, effects of IRAK4 degradation on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients.
De-identified routine clinical data that is collected will be correlated with the research findings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hidradenitis suppurativa | – | –Subjects with active mild, moderate, or severe HS disease using the HS-PGA assessment |
| Atopic Dermatitis | – | –Subjects with active moderate or severe AD disease using the PGA assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active mild, moderate, or severe HS or active moderate or severe AD disease.
Key inclusion criteria (4 listed)
- Age 18 or older
- Active HS or AD disease, diagnosed by PI
- Patients with mild (HS only), moderate, or severe disease using the HS-PGA or PGA assessment.
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study.
Key exclusion criteria (3 listed)
- Patient is currently on a biologic or other immunosuppressive treatment for HS or AD.
- Use of biologic treatment for HS or AD within 3 months or 5 half-lives, whichever is longer
- Use of non-biologic immunosuppressive treatment (eg. Cyclosporin) in the last 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarker Identification
Time frame: Day 1
Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples
Determination of Biomarker Correlations
Time frame: Day 1
Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity
Examination of IRAK4 Degradation Effects Ex Vivo
Time frame: Day 1
Examine effect of IRAK4 degrader on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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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.
Afsaneh Alavi, MD principal investigator
York Dermatology Clinic and Research Centre
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 Hidradenitis Suppurativa and Dermatitis, Atopic, run by Kymera Therapeutics, 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 4 inclusion and 3 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 13 Apr 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarker Identification (time frame: Day 1). The study lists 3 primary outcomes in all. 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 13 Apr 2021.