Atopic DermatitisEarly Phase 1NCT05372003
IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
A Early Phase 1 study testing Dupilumab and Photo therapy in people with Atopic Dermatitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab and Photo therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to 23 Feb 2024
- Phase
- Early Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to sign informed consent form.
- Body mass index (BMI), 22-29 kg/m^2.
- Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.
- Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.
Who cannot join
- Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.
- Evidence of diabetes mellitus.
- Morning Cortisol < 5 mg/dl (collected before 10.30 am).
- Presence of acute illness.
- Low hemoglobin or hematocrit.
- Current participation in a weight-loss regimen, with a weight loss > 10% total body weight in the last 6 months).
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- Smoking history in the last 6 months (tobacco, nicotine-containing products including e-cigarettes).
- Pregnant or breastfeeding.
- Personal history of gastric bypass surgery.
- Previous participation in a clinical trial with an investigational product in the past 30 days, or 5 half-lives, or twice the duration of the biological effect of the investigational drug (whichever is longest).
- Exposed to more than 4 new chemical entities within 12 months before study enrollment.
- Any other condition or event considered exclusionary by the PI and the study physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IL-4 & Insulin Resistance in Patients With Atopic Dermatitis
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.
Read the detailed description
Patients with a body mass index (BMI) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. Researchers will compare in vivo evaluations of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and BMI, with atopic dermatitis, but without dupilumab therapy (phototherapy).
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab, Photo therapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
dupilumab injections will be prescribed and managed by dermatology as standard of care
Photo therapyOther
Also called light therapy
light therapy will be prescribed and managed by dermatology as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Subjects on Dupilumab | Experimental | individuals with atopic dermatitis placed on dupilumab for more than 6 months will be eligible to this study. Their metabolic profile will be compared to the group of "Subjects on Phototherapy" Receives: Drug: Dupilumab |
| Subjects on Phototherapy | Active comparator | individuals with atopic dermatitis placed on phototherapy for more than 6 months will be eligible to this study to serve as an active comparator to the "Subjects with Dupilumab" Receives: Other: Photo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homa IR
Homeostatic Model Assessment of Insulin Resistance will be calculated by multiplying the fasting glucose concentration (mg/dl) by the fasting insulin concentration (mmol/L).
Measured: baseline
Matsuda Index
The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.
Measured: baseline
Secondary outcomes (4)
Adipo-IR
Adipo-IR will be calculated by multiplying the fasting FFA concentration (mmol/L) by the fasting insulin concentration (pmol/L) obtained during the baseline blood collection during the oral glucose tolerance test
Measured: baseline
Systemic inflammatory markers
Circulating plasma levels of inflammatory markers interleukin 1 (IL1), Tumor necrosis factor alpha (TNFa), highly sensitive C-reactive protein (hs-CRP), Monocyte Chemoattractant Protein 1 (MCP1), interleukin 6 (IL-6), Interleukin 4 (IL-4) and interleukin 13 (IL13)
Measured: baseline
Adipokines
We will measure the plasma levels of adipokines (leptin and adiponectin) by radioimmunoassay and ELISA in all subjects recruited and compared across study group
Measured: baseline
Fasting Free Fatty Acid
During the OGTT, we will collect fasting blood to assess levels of plasma free fatty acid (mmol/L). These values will be compared across the 2 different group studied.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start9 Aug 2022
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Anna (Eleanna) De Filippis, M.D., Ph.D., Mayo Clinic
- Investigators
- Elena Anna De Filippis, MD, PhD, Principal investigator, Mayo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372003
- Sponsor's protocol ID
- 22-002567
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-4 & Insulin Resistance in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05372003
- Acronym / sponsor ID
- 22-002567
- Conditions
- Atopic Dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 12 May 2022 (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.
The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.
Detailed description
Patients with a body mass index (BMI) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. Researchers will compare in vivo evaluations of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and BMI, with atopic dermatitis, but without dupilumab therapy (phototherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects on Dupilumab | Experimental | Drug: Dupilumabindividuals with atopic dermatitis placed on dupilumab for more than 6 months will be eligible to this study. Their metabolic profile will be compared to the group of "Subjects on Phototherapy" |
| Subjects on Phototherapy | Active comparator | Other: Photo therapyindividuals with atopic dermatitis placed on phototherapy for more than 6 months will be eligible to this study to serve as an active comparator to the "Subjects with Dupilumab" |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to sign informed consent form.
- Body mass index (BMI), 22-29 kg/m^2.
- Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.
- Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.
Key exclusion criteria (12 listed)
- Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.
- Evidence of diabetes mellitus.
- Morning Cortisol < 5 mg/dl (collected before 10.30 am).
- Presence of acute illness.
- Low hemoglobin or hematocrit.
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 |
|---|---|---|
| Dupilumabdupilumab injections will be prescribed and managed by dermatology as standard of care | Drug | Subjects on Dupilumab |
| Photo therapyAlso: light therapylight therapy will be prescribed and managed by dermatology as standard of care | Other | Subjects on Phototherapy |
Primary outcome
Homa IR
Time frame: baseline
Homeostatic Model Assessment of Insulin Resistance will be calculated by multiplying the fasting glucose concentration (mg/dl) by the fasting insulin concentration (mmol/L).
Matsuda Index
Time frame: baseline
The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.
4 secondary outcomes
Adipo-IR
Time frame: baseline
Systemic inflammatory markers
Time frame: baseline
Adipokines
Time frame: baseline
Fasting Free Fatty Acid
Time frame: baseline
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 26 Feb 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Elena Anna De Filippis, MD, PhD principal investigator
Mayo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dupilumab and Photo therapy in people with Atopic Dermatitis, run by Mayo Clinic at 1 site in United States.
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 12 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 26 Feb 2024. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Homa IR (time frame: baseline). The study lists 2 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 26 Feb 2024.