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

• Status: Not yet recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eric Simpson
• Collaborator: Regeneron Pharmaceuticals

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