NCT04520308UnknownPhase 4
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
Eric Simpson0 sites45 target enrollmentStarted: September 1, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 45
- Primary Endpoint
- Mean change from baseline in nerve length at week 24 in patients with AD
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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:
- •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
- •Exclusion Criteria for all patients (not all inclusive):
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
dupilumab
Experimental
Intervention: Dupilumab Only Product (Drug)
Outcomes
Primary Outcomes
Mean change from baseline in nerve length at week 24 in patients with AD
Time Frame: 24 weeks
Measured using confocal microscopy.
Secondary Outcomes
- Mean change from baseline in dermal and epidermal nerve branching at week 24 for patients with AD(24 weeks)
- Mean change from baseline in nerve substance P expression at week 24 for patients with AD(24 weeks)
- Mean change from baseline in keratinocyte TSLP expression at week 24 for patients with AD(24 weeks)
- Mean change from baseline in eosinophil number and proximity to cutaneous nerves at week 24 for patients with AD(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(24 weeks)
- Mean change from baseline in nerve IL-4 receptor alpha (IL-4Rα) expression at week 24 for patients with AD(24 weeks)
- Mean change from baseline in extracellular eosinophil peroxidase (EPX) staining at week 24 for patients with AD(24 weeks)
- Difference between normal control patients and patients with AD at baseline in mean dermal nerve branching(24 weeks)
- Difference between normal control patients and patients with AD at baseline in mean nerve substance P expression(24 weeks)
- Difference between normal control patients and patients with AD at baseline in mean nerve TSLP receptor and IL-31 receptor expression(24 weeks)
- Difference between normal control patients and patients with AD at baseline in mean nerve IL-4Rα expression(24 weeks)
- Difference between normal control patients and patients with AD at baseline in mean keratinocyte TSLP expression(24 weeks)
- Difference between normal control patients and patients with AD at baseline in mean eosinophil number and proximity to cutaneous nerves(24 weeks)
- Difference between normal control patients and patients with AD at baseline in mean extracellular EPX staining(24 weeks)
- Mean change from baseline scores in pruritus numeric rating scale (NRS) at week 24 for patients with AD(24 weeks)
- Mean change from baseline in patient global assessment (PGA) at week 24 for patients with AD(24 weeks)
- Mean change from baseline in investigator's global assessment (IGA) at week 24 for patients with AD(24 weeks)
- Mean change from baseline in Eczema Area and Severity Index (EASI) at week 24 for patients with AD(24 weeks)
- Mean change from baseline in Skindex-3 scale ratings at week 24 for patients with AD(24 weeks)
- Mean change from baseline in Sensitive Scale-10 at week 24 for patients with AD(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(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(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(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.(24 weeks)
Investigators
Eric Simpson
Professor
Oregon Health and Science University
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