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

Sponsor
Eric Simpson
Study ID
NCT04520308
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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

Study Details

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

Key Dates

Start date
Sep 1, 2020
Status verified
Aug 2020
Primary completion
Feb 26, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: dupilumab

Primary Outcome Measure

Mean change from baseline in nerve length at week 24 in patients with AD [ Time Frame: 24 weeks ]

Central Contacts

Related Studies