Status:
UNKNOWN
An Open-label, Single-arm Longitudinal Study With Dupilumab for Patients With Atopic Dermatitis
Lead Sponsor:
Eric Simpson
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Atopic Dermatitis
AD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 patien...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04520308
Start Date
September 1 2020
End Date
March 31 2021
Last Update
August 20 2020
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