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

NCT04520308 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-08-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Eric Simspon, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-02-26
Completion
2021-03-31
FDA Drug
Yes

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04520308 on ClinicalTrials.gov