Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04520308
Other study ID # STUDY00021061
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date March 31, 2021

Study information

Verified date August 2020
Source Oregon Health and Science University
Contact Cody Blankenship
Phone 503-494-0171
Email blankeco@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date March 31, 2021
Est. primary completion date February 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dupilumab Only Product
SC injections of 300 mg dupilumab every 2 weeks for 24 weeks following a loading dose of 600 mg on day 1

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Eric Simpson Regeneron Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in nerve length at week 24 in patients with AD Measured using confocal microscopy. 24 weeks
Secondary Mean change from baseline in dermal and epidermal nerve branching at week 24 for patients with AD Measured using confocal microscopy. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary Mean change from baseline in nerve IL-4 receptor alpha (IL-4Ra) expression at week 24 for patients with AD Tissue whole mounts will be used to quantify neuronal expression of IL-31R and IL-4Ra. 24 weeks
Secondary 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.. 24 weeks
Secondary 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.. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary Difference between normal control patients and patients with AD at baseline in mean nerve IL-4Ra expression Tissue whole mounts will be used to quantify neuronal expression of IL-4Ra via microscopic examination. Control patients will be compared with AD patients. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
Secondary 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). 24 weeks
Secondary 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. 24 weeks
Secondary 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". 24 weeks
Secondary 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). 24 weeks
Secondary 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. 24 weeks
Secondary 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). 24 weeks
Secondary 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. 24 weeks
Secondary 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. 24 weeks
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2