Atopic DermatitisPhase 4NCT04520308
An Open-label, Single-arm Longitudinal Study With Dupilumab for Patients With Atopic Dermatitis
A Phase 4 study testing Dupilumab Only Product in people with Atopic Dermatitis and AD, run by Eric Simpson.
Trial summary
24-week, open-label, single-arm longitudinal study of patients with AD, including a comparison between baseline values for adult patients with moderate-to-severe AD and untreated normal control patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, AD, Eczema
- What is being tested?
- Dupilumab Only Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Mar 2021
- Phase
- Phase 4
- 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
Who may be able to join
- All patients:
- Male or female, 18 years or older
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Have applied a stable dose of topical emollient (moisturizer) once daily for at least 7 days before the day 1 visit
- AD patients only:
Show all 11Show fewer
- Chronic AD
- Eczema Area and Severity Index (EASI) ≥16 at screening and day 1 visits
- Investigator's global assessment (IGA) ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and day 1 visits
- Body surface area of involvement of AD (BSA) ≥10% at screening and day 1 visits
- Documented recent history (within 6 months before screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
Who cannot join
- Prior use of dupilumab or other anti-IL-4 treatments (prescription or as part of a clinical study) within 1 year of screening
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) before the day 1 visit, whichever is longer
- Having used immunosuppressive drugs or phototherapy within the last 4 weeks
- Treatment with TCS or TCI within 1 week before the day 1 visit
- Regular use (>2 visits/week) of a tanning booth/parlor within 4 weeks before the screening visit
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Interleukin (IL)-4/IL-13 Blockade on the Structure and Function of Cutaneous Sensory Nerves: An Open-label, Single-arm Longitudinal Study With Dupilumab
24-week, open-label, single-arm longitudinal study of patients with AD, including a comparison between baseline values for adult patients with moderate-to-severe AD and untreated normal control patients.
Patients with AD: ≤24 to 29 weeks, including the screening period Normal control patients: ≤2 days to 5 weeks, including the screening period.
Patients with AD: adults with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable (eg, intolerance, other important side effects or safety risks)
Normal control patients: adults without AD or other atopic disease
- Conditions
- Atopic Dermatitis, AD, Eczema
- Being tested
- Dupilumab Only Product
- 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.
Dupilumab Only ProductDrug
Also called dupixent
SC injections of 300 mg dupilumab every 2 weeks for 24 weeks following a loading dose of 600 mg on day 1
| Study group | Role | What they receive |
|---|---|---|
| dupilumab | Experimental | Not described Receives: Drug: Dupilumab Only Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in nerve length at week 24 in patients with AD
Measured using confocal microscopy.
Measured: 24 weeks
Secondary outcomes (24)
Mean change from baseline in dermal and epidermal nerve branching at week 24 for patients with AD
Measured using confocal microscopy.
Measured: 24 weeks
Mean change from baseline in nerve substance P expression at week 24 for patients with AD
Tissue whole mounts will be used to quantify neuronal expression of substance P.
Measured: 24 weeks
Mean change from baseline in nerve thymic stromal lymphopoietin (TSLP) receptor and IL-31 receptor expression at week 24 for patients with AD
Tissue whole mounts will be used to quantify neuronal expression of TSLP.
Measured: 24 weeks
Mean change from baseline in nerve IL-4 receptor alpha (IL-4Rα) expression at week 24 for patients with AD
Tissue whole mounts will be used to quantify neuronal expression of IL-31R and IL-4Rα.
Measured: 24 weeks
Mean change from baseline in keratinocyte TSLP expression at week 24 for patients with AD
Tissue whole mounts will be used to quantify keratinocyte TSLP expression via microscopic examination..
Measured: 24 weeks
Mean change from baseline in eosinophil number and proximity to cutaneous nerves at week 24 for patients with AD
Tissue whole mounts will be used to quantify eosinophil number and proximity to nerves via microscopic examination..
Measured: 24 weeks
Mean change from baseline in extracellular eosinophil peroxidase (EPX) staining at week 24 for patients with AD
Tissue whole mounts will be used to quantify EPX staining via microscopic examination.
Measured: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean dermal nerve branching
Measured using confocal microscopy. Control patients will be compared with AD patients.
Measured: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean nerve substance P expression
Tissue whole mounts will be used to quantify neuronal expression of substance P. Control patients will be compared with AD patients.
Measured: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean nerve TSLP receptor and IL-31 receptor expression
Tissue whole mounts will be used to quantify neuronal expression of TSLP and IL-31R. Control patients will be compared with AD patients.
Measured: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean nerve IL-4Rα expression
Tissue whole mounts will be used to quantify neuronal expression of IL-4Rα via microscopic examination. Control patients will be compared with AD patients.
Measured: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean keratinocyte TSLP expression
Tissue whole mounts will be used to quantify keratinocyte TSLP expression via microscopic examination. Control patients will be compared with AD patients.
Measured: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean eosinophil number and proximity to cutaneous nerves
Tissue whole mounts will be used to quantify eosinophil number and proximity to nerves via microscopic examination. Control patients will be compared with AD patients.
Measured: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean extracellular EPX staining
Tissue whole mounts will be used to quantify EPX staining via microscopic examination. Control patients will be compared with AD patients.
Measured: 24 weeks
Mean change from baseline scores in pruritus numeric rating scale (NRS) at week 24 for patients with AD
Patients will report the intensity of their pruritus using the pruritus numeric scale (NRS), a 0-10 scale (0 being 'no itch' and 10 being the 'worst itch imaginable'). This scale captures rate of itch overall (average itch intensity) during the previous 24 hours and rate of itch at the worst moment (maximum itch intensity) during the previous 24 hours.
Measured: 24 weeks
Mean change from baseline in patient global assessment (PGA) at week 24 for patients with AD
Patients will rate their overall well-being (poor, fair, good, very good, excellent) using the patient global assessment (PGA). Patients will also rate their atopic dermatitis/eczema as: clear, almost clear, mild, moderate, or severe.
Measured: 24 weeks
Mean change from baseline in investigator's global assessment (IGA) at week 24 for patients with AD
Investigators will rate the severity of AD globally, based on a 5 point scale ranging from 0 (clear) to 4 (severe).
Measured: 24 weeks
Mean change from baseline in Eczema Area and Severity Index (EASI) at week 24 for patients with AD
Investigators will assess the severity and extent of AD with the EASI composite index. Severity scores range from 0 to 72 for AD disease characteristics, which will be assessed by the investigator on a scale of "0" (absent) through "3" (severe). The area of AD involvement will be assessed as a percentage by body area and converted to a score of 0 to 6.
Measured: 24 weeks
Mean change from baseline in Skindex-3 scale ratings at week 24 for patients with AD
The Skindex-3 is a 3-question quality of life assessment, which will assess patients' current state of activity (going out, work activities or relationships with others), emotion (worry, embarrassment, frustration), and skin symptoms (itching, stinging, burning, hurting or skin irritation). Each question is graded on a scale of 0 "never bothered" to 6 "always bothered".
Measured: 24 weeks
Mean change from baseline in Sensitive Scale-10 at week 24 for patients with AD
Patients will self-report degree and severity of overall skin irritation on a scale of 1-10 (0 = absence of irritation, 10 = intolerable irritation).
Measured: 24 weeks
Mean change from baseline in non-lesional skin sensitivity (stinger assay, measured with skin symptom scale) at week 24 for patients with AD
Non-lesional skin sensitivity will be assessed via the stinger assay using 5% lactic acid with patient-reported stinging. The scale of stinging skin symptoms will be used: 0 = none; 1 = slight; 2 = moderate; and 3 = severe.
Measured: 24 weeks
Mean change from baseline in lesional and non-lesional skin hydration (Trans-Epidermic Water Loss, measured in g/h·m2) at week 24 for patients with AD
Trans-Epidermic Water Loss of lesional and non-lesional skin will also be assessed using non-invasive skin probe (g/h·m2).
Measured: 24 weeks
Mean change from baseline in lesional and non-lesional skin hydration scores (corneometry, measured in units) at week 24 for patients with AD
Hydration of lesional and non-lesional skin will be assessed via non-invasive probes.
Measured: 24 weeks
Mean change from baseline scores in lesional and non-lesional at-home skin barrier testing (measuring skin hydration by Trans-Epidermic Water Loss and Stratum Corneum Hydration, assessed in units) using a GP device at 24 weeks for patients with AD.
Lesional and non-lesional skin hydration (Trans-Epidermic Water Loss and Stratum Corneum Hydration, assessed in units) by patients using an at-home GP skin barrier device.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion26 Feb 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
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.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Simpson
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Eric Simpson, Oregon Health and Science University
- Investigators
- Eric Simspon, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520308
- Sponsor's protocol ID
- STUDY00021061
- Status last verified
- Aug 2020
- First submitted
- 24 Jul 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interleukin (IL)-4/IL-13 Blockade on the Structure and Function of Cutaneous Sensory Nerves: An Open-label, Single-arm Longitudinal Study With Dupilumab
- ClinicalTrials.gov ID
- NCT04520308
- Acronym / sponsor ID
- STUDY00021061
- Conditions
- Atopic Dermatitis, AD, Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Eric SimpsonUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 26 Feb 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 20 Aug 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.
24-week, open-label, single-arm longitudinal study of patients with AD, including a comparison between baseline values for adult patients with moderate-to-severe AD and untreated normal control patients.
Patients with AD: ≤24 to 29 weeks, including the screening period Normal control patients: ≤2 days to 5 weeks, including the screening period.
Patients with AD: adults with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable (eg, intolerance, other important side effects or safety risks)
Normal control patients: adults without AD or other atopic disease
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dupilumab | Experimental | Drug: Dupilumab Only Product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, 18 years or older
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Have applied a stable dose of topical emollient (moisturizer) once daily for at least 7 days before the day 1 visit
- Chronic AD
Key exclusion criteria (5 listed)
- Prior use of dupilumab or other anti-IL-4 treatments (prescription or as part of a clinical study) within 1 year of screening
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) before the day 1 visit, whichever is longer
- Having used immunosuppressive drugs or phototherapy within the last 4 weeks
- Treatment with TCS or TCI within 1 week before the day 1 visit
- Regular use (>2 visits/week) of a tanning booth/parlor within 4 weeks before the screening visit
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 |
|---|---|---|
| Dupilumab Only ProductAlso: dupixentSC injections of 300 mg dupilumab every 2 weeks for 24 weeks following a loading dose of 600 mg on day 1 | Drug | dupilumab |
Primary outcome
Mean change from baseline in nerve length at week 24 in patients with AD
Time frame: 24 weeks
Measured using confocal microscopy.
24 secondary outcomes
Mean change from baseline in dermal and epidermal nerve branching at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in nerve substance P expression at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in nerve thymic stromal lymphopoietin (TSLP) receptor and IL-31 receptor expression at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in nerve IL-4 receptor alpha (IL-4Rα) expression at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in keratinocyte TSLP expression at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in eosinophil number and proximity to cutaneous nerves at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in extracellular eosinophil peroxidase (EPX) staining at week 24 for patients with AD
Time frame: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean dermal nerve branching
Time frame: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean nerve substance P expression
Time frame: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean nerve TSLP receptor and IL-31 receptor expression
Time frame: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean nerve IL-4Rα expression
Time frame: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean keratinocyte TSLP expression
Time frame: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean eosinophil number and proximity to cutaneous nerves
Time frame: 24 weeks
Difference between normal control patients and patients with AD at baseline in mean extracellular EPX staining
Time frame: 24 weeks
Mean change from baseline scores in pruritus numeric rating scale (NRS) at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in patient global assessment (PGA) at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in investigator's global assessment (IGA) at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in Eczema Area and Severity Index (EASI) at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in Skindex-3 scale ratings at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in Sensitive Scale-10 at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in non-lesional skin sensitivity (stinger assay, measured with skin symptom scale) at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in lesional and non-lesional skin hydration (Trans-Epidermic Water Loss, measured in g/h·m2) at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline in lesional and non-lesional skin hydration scores (corneometry, measured in units) at week 24 for patients with AD
Time frame: 24 weeks
Mean change from baseline scores in lesional and non-lesional at-home skin barrier testing (measuring skin hydration by Trans-Epidermic Water Loss and Stratum Corneum Hydration, assessed in units) using a GP device at 24 weeks for patients with AD.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- 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.
Eric Simspon, MD principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab Only Product in people with Atopic Dermatitis and AD, run by Eric Simpson.
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 11 inclusion and 5 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 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cody Blankenship (503-494-0171, blankeco@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in nerve length at week 24 in patients with AD (time frame: 24 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 20 Aug 2020; AzTrials last refreshed its copy on 1 Nov 2026.