The Effects of Dupilumab on Allergic Contact Dermatitis

Last updated: February 10, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Allergy

Rosacea

Eczema (Atopic Dermatitis - Pediatric)

Treatment

Dupilumab

Clinical Study ID

NCT03935971
2018P002882
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age

  2. At least one contact allergen with a 2+ (strong) or 3+ (extreme reaction) confirmedby patch testing within 6 months of the baseline visit that can be duplicated at theinitiation of the study (placement at Week 0 and patch test reaction read at Week 0 +72-120 hours).

  3. Allergic contact dermatitis diagnosed clinically by the principle investigators whohave expertise in allergic contact dermatitis

  4. Investigator's global assessment score of at least 3 (range 0-4) at the screeningand baseline visits

  5. Documented recent history (within 18 months of patch testing) of inadequate responseto treatment with topical medications and allergen avoidance

  6. Able and willing to provide informed consent, participate in study visits, andundergo visit procedures

Exclusion

Exclusion Criteria:

  1. Prior dupilumab use

  2. Treatment with a systemic immune-regulating medication within 3 months of thebaseline visit or the patient's prior patch testing, whichever is longer. Examplesof these medications include azathioprine, methotrexate, mycophenolate mofetil,Janus kinase inhibitors, and phototherapy (including tanning booths). Cyclosporineor prednisone may not have been used within 1 month of the baseline visit.

  3. 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 thepatient's prior patch testing, whichever is longer.

  4. Use of rituximab within at 6 months (or until lymphocyte counts have normalized iflonger than 6 months) of the baseline visit or the patient's prior patch testing,whichever is longer.

  5. Treatment with topical corticosteroids or topical calcineurin inhibitors within 1week before the baseline visit

  6. Other active conditions, such as psoriasis, that may confound clinical evaluationsof dermatitis and patient-reported symptoms

  7. Increased risk of infection or reactivated infection, including history of humanimmunodeficiency virus, hepatitis B, hepatitis C, endoparasitic infections, receiptof a live attenuated vaccine within 3 months of the baseline visit, chronic or acuteinfection requiring treatment within 4 weeks of the baseline visit, immunosuppressedstatus (ie recurrent or resistant opportunistic infections)

  8. Malignancy within 5 years of the screening visit excluding local cutaneous squamouscell carcinoma, basal cell carcinoma or cervical carcinoma in situ that has beenfully treated.

  9. Women who are or plan to become pregnant or breastfeed during study participation orare unable or not willing to use birth control during the study and for 4 monthsafter the last dose of dupilumab. Options for birth control include abstinence,double barrier (ie male condom and female diaphragm), vasectomy, intrauterinedevice, and hormonal contraception. Females who have not had menses within 1 year ofthe baseline, bilateral tubal ligation, hysterectomy, and/or bilateral oophorectomyvisit do not require additional methods contraception during study participation.

  10. Unstable condition or status, as per study investigator's judgment, that may lead tomore likely discontinuation from the study including but not limited to major,recurrent medical illnesses that may require hospital admission and/ordiscontinuation of dupilumab, surgery that would require discontinuation ofdupilumab and/or major rehabilitation, inability to participate in all study visitsand administer dupilumab

  11. Resident outside of Massachusetts, Connecticut, Rhode Island, New Hampshire, Maineor Vermont state.

  12. Unable to use Zoom videoconferencing.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase: 4
Study Start date:
December 18, 2019
Estimated Completion Date:
July 31, 2025

Study Description

The investigators will recruit 30 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 18 months after patch testing, but where allergic contact dermatitis is still suspected. Subjects will receive 10 weeks of dupilumab, and both clinical data and tissue samples will be assessed.

Connect with a study center

  • Brigham and Women's Hospital, Department of Dermatology

    Boston, Massachusetts 02115
    United States

    Site Not Available

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