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

Eric Simpson

Status and phase

Unknown

Phase 4

Conditions

Atopic Dermatitis

Eczema

Treatments

Drug: Dupilumab Only Product

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04520308

STUDY00021061

Details and patient eligibility

About

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

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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