An Open-label, Single-arm Longitudinal Study With Dupilumab for Patients With Atopic Dermatitis

NCT04520308 | Unknown Phase 4 FDA Drug

• 1 other identifier: STUDY00021061
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Atopic Dermatitis; AD; Eczema

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in nerve length at week 24 in patients with AD

  Measured using confocal microscopy.

  24 weeks

Secondary Outcomes (24)

• 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 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 keratinocyte TSLP expression at week 24 for patients with AD

  24 weeks

Study Arms (1)

dupilumab

EXPERIMENTAL

Drug: Dupilumab Only Product

Interventions

Dupilumab Only Product DRUG

SC injections of 300 mg dupilumab every 2 weeks for 24 weeks following a loading dose of 600 mg on day 1

Also known as: dupixent

dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eric Simpson: lead
• Regeneron Pharmaceuticals: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eric Simspon, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cody Blankenship

CONTACT

503-494-0171; blankeco@ohsu.edu

Lindsay Chandler

CONTACT

503-494-2316; chandlli@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 20, 2020
• Study Start: September 1, 2020
• Primary Completion: February 26, 2021
• Study Completion: March 31, 2021
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share