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

NCT ID: NCT04520308

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-03-31

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 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

Atopic Dermatitis; AD; Eczema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

dupilumab

Group Type: EXPERIMENTAL

Dupilumab Only Product

Intervention Type: DRUG

SC injections of 300 mg dupilumab every 2 weeks for 24 weeks following a loading dose of 600 mg on day 1

Interventions

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

Intervention Type: DRUG

Other Intervention Names

dupixent

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Eric Simpson

OTHER

Sponsor Role: lead

Responsible Party

Eric Simpson

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eric Simspon, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Central Contacts

Cody Blankenship

Role: CONTACT

blankeco@ohsu.edu

503-494-0171

Lindsay Chandler

Role: CONTACT

chandlli@ohsu.edu

503-494-2316

Other Identifiers

STUDY00021061

Identifier Type: -

Identifier Source: org_study_id