The Effects of Dupilumab on Allergic Contact Dermatitis

NCT03935971 | Active Not Recruiting Phase 4 Results FDA Drug

• 1 other identifier: 2018P002882
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.

Conditions

Allergic Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Investigator's Global Assessment (IGA) Score

  The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe.

  week 0, week 6, week 12

Secondary Outcomes (7)

• Change in Body Surface Area (BSA)

  week 0, week 6, week 12

• Change in Eczema Area and Severity Index (EASI) Score

  week 0, week 6, week 12

• Change in Numerical Rating Scale (NRS) Itch

  week 0, week 6, week 12

• Change in Dermatology Life Quality Index (DLQI)

  week 0, week 6, week 12

• Change in SLEEPY-Q (Sleep Questionnaire) Score

  week 0, week 6, week 12

Study Arms (1)

Subjects with Allergic Contact Dermatitis

EXPERIMENTAL

Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks

Drug: Dupilumab

Interventions

Dupilumab DRUG

See arm/group description

Subjects with Allergic Contact Dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• At least one contact allergen with a 2+ (strong) or 3+ (extreme reaction) confirmed by patch testing within 6 months of the baseline visit that can be duplicated at the initiation of the study (placement at Week 0 and patch test reaction read at Week 0 +72-120 hours).
• Allergic contact dermatitis diagnosed clinically by the principle investigators who have expertise in allergic contact dermatitis
• Investigator's global assessment score of at least 3 (range 0-4) at the screening and baseline visits
• Documented recent history (within 18 months of patch testing) of inadequate response to treatment with topical medications and allergen avoidance
• Able and willing to provide informed consent, participate in study visits, and undergo visit procedures

You may not qualify if:

• Prior dupilumab use
• Treatment with a systemic immune-regulating medication within 3 months of the baseline visit or the patient's prior patch testing, whichever is longer. Examples of these medications include azathioprine, methotrexate, mycophenolate mofetil, Janus kinase inhibitors, and phototherapy (including tanning booths). Cyclosporine or prednisone may not have been used within 1 month of the baseline visit.
• Treatment with other biologic agents, such as TNF inhibitors, anti-IL 17 agents, anti-IL 12/23 agents, or anti-IL 23 agents, within 4 months of baseline visit or the patient's prior patch testing, whichever is longer.
• Use of rituximab within at 6 months (or until lymphocyte counts have normalized if longer than 6 months) of the baseline visit or the patient's prior patch testing, whichever is longer.
• Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit
• Other active conditions, such as psoriasis, that may confound clinical evaluations of dermatitis and patient-reported symptoms
• Increased risk of infection or reactivated infection, including history of human immunodeficiency virus, hepatitis B, hepatitis C, endoparasitic infections, receipt of a live attenuated vaccine within 3 months of the baseline visit, chronic or acute infection requiring treatment within 4 weeks of the baseline visit, immunosuppressed status (ie recurrent or resistant opportunistic infections)
• Malignancy within 5 years of the screening visit excluding local cutaneous squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ that has been fully treated.
• Women who are or plan to become pregnant or breastfeed during study participation or are unable or not willing to use birth control during the study and for 4 months after the last dose of dupilumab. Options for birth control include abstinence, double barrier (ie male condom and female diaphragm), vasectomy, intrauterine device, and hormonal contraception. Females who have not had menses within 1 year of the baseline, bilateral tubal ligation, hysterectomy, and/or bilateral oophorectomy visit do not require additional methods contraception during study participation.
• Unstable condition or status, as per study investigator's judgment, that may lead to more likely discontinuation from the study including but not limited to major, recurrent medical illnesses that may require hospital admission and/or discontinuation of dupilumab, surgery that would require discontinuation of dupilumab and/or major rehabilitation, inability 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Brigham and Women's Hospital, Department of Dermatology

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: BWH Dermatology Research Project Coordinator
• Organization: Brigham and Women's Hospital

lchacin@bwh.harvard.edu

617-264-5696

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 2, 2019
• Study Start: December 18, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Locations

US (1)