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The Effects of Dupilumab on Allergic Contact Dermatitis

StatusActive, Not Recruiting
PhasePhase 4
Started2019-12-18
View on ClinicalTrials.gov ↗

Amendment history

2026-06-25
minor
Study Status v8
Completion pushed: 2026-07-31 → 2027-03-31
2026-02-08
minor
Study Status, Study Design, Outcome Measures, Participant Flow, Outcome Measures (Results), Adverse Events v7
Results first postednot stated→2026-02-27
Enrollment target30→17
Primary endpoints1 entry, revised
Change From Baseline in Investigator's Global Assessment (IGA) Score
2025-12-24
minor
Study Status, Oversight, Study Design, Outcome Measures, IPDSharing, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v6
Completion date2025-07-31→2026-07-31
Enrollment target9→30
Secondary endpoints7 entries, revised
Change in Eczema Area and Severity Index (EASI) scoreScore Change in Numerical Rating Scale (NRS) itchItch Change in SLEEPY-Q (Sleep Questionnaire) scoreScore
Primary endpoints1 entry, revised
Change in Investigator's Global Assessment (IGA) scoreScore
2025-02-10
notable
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Design, Contacts/Locations, IPDSharing v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2023-12→confirmed 2024-12-31
Completion date2023-12→2025-07-31
Enrollment targetestimated 30→confirmed 9
Study sitesdetails revised at 1 of 1 site
2023-10-29
minor
Study Status, Study Description, Study Design, Eligibility v4
Primary completion date2023-05→2023-12
Completion date2023-05→2023-12
Enrollment target20→30
Eligibility criteria+140 characters
[...] ening and baseline visits Documented recent history (within 618 months of patch testing) of inadequate response to treatmen [...] to participate in all study visits and administer dupilumab Resident outside of Massachusetts, Connecticut, Rhode Island, New Hampshire, Maine or Vermont state. Unable to use Zoom videoconferencing.
Study description+1 characters
The investigators will recruit 2030 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 618 months after patch testing, but where allergic contact derm [...]
Show 3 earlier versions
2021-10-12
minor
Study Status, Sponsor/Collaborators v3
Primary completion date2021-12→2023-05
Completion date2021-12→2023-05
2020-03-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2021-09→2021-12
Completion date2021-09→2021-12
Start dateestimated 2019-09→confirmed 2019-12-18
Study sites0→1
2019-07-10
minor
Study Status v1
Primary completion date2021-05→2021-09
Completion date2021-05→2021-09
Start date2019-05→2019-09
2019-05-01
minor
Original filing
The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.
Trial Details
NCT Number NCT03935971
Lead Sponsor Brigham and Women's Hospital
Collaborators: Regeneron Pharmaceuticals
Conditions Allergic Contact Dermatitis
Enrollment 17 participants
Start Date 2019-12-18
Primary Completion 2024-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16