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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

The Effects of Dupilumab on Allergic Contact Dermatitis

Clinicaltrials.gov identifier NCT03935971

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted March 18, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Allergic Contact Dermatitis
  • Intervention/Treatment: Drug: Dupilumab
  • Phase: Phase 4
Detailed Description

The investigators will recruit 20 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 6 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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: The Effects of Dupilumab on Allergic Contact Dermatitis
  • Actual Study Start Date: December 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Subjects with Allergic Contact Dermatitis
Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks
Drug: Dupilumab
See arm/group description
Outcome Measures
  • Primary Outcome Measures: 1. Change in Investigator's Global Assessment (IGA) score [ Time Frame: week 0, week 6, week 12 ]
    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
  • Secondary Outcome Measures: 1. Change in Body Surface Area (BSA) [ Time Frame: week 0, week 6, week 12 ]
    The body surface area is a physician-reported measure of the amount of disease involvement. The patient's palm size approximates 1% of body surface area involvement.
  • 2. Change in Eczema Area and Severity Index (EASI) score [ Time Frame: week 0, week 6, week 12 ]
    The eczema-area-and-severity-index score is a composite score of disease severity and extent of disease distribution. It was initially developed for evaluation of eczema. Disease severity (range 0-3; 0 being no disease and 3 being severe disease) is a measure of redness, thickness/induration, scratching, and lichenification. Each characterization is measured separately for body regions (head and neck, trunk, upper extremities, and lower extremities) to calculate a regional score. The total score is a sum of the four body regions (range 0-72).
  • 3. Change in Numerical Rating Scale (NRS) itch [ Time Frame: week 0, week 6, week 12 ]
    The numerical rating scale for itch is a patient-reported measure of itch (range 0-10) with 0 being no itch and 10 being the worst imaginable itch.
  • 4. Change in Dermatology Life Quality Index (DLQI) [ Time Frame: week 0, week 6, week 12 ]
    The Dermatology Life Quality Index is a 10-question, patient-reported instrument to assess impact of skin diseases on patient quality of life.
  • 5. Change in SLEEPY-Q (Sleep Questionnaire) score [ Time Frame: week 0, week 6, week 12 ]
    The Sleepy-Q is a patient-derived, patient-reported sleep questionnaire for patients with chronic inflammatory dermatoses that consists of 28 individual questions. It assesses four dimensions of sleep in patients with inflammatory skin conditions: sleep disturbance (overall score 0-40, 0 being "no sleep disturbance" and 40 being "severe sleep disturbance"), causes of sleep disturbance related to dermatitis (binary, yes/no), causes of sleep disturbance unrelated to dermatitis (binary, yes/no), and impairment related to sleep disturbance (two subscales including Life Impairment Score = overall 0-40, being 0 "no life impairment" and 40 "severe life impairment" and Dermatitis Impairment Score = overall 0-30, being 0 "no impairment" and 30 "severe impairment." The total impairment related to sleep disturbance is scored overall 0-70 after summing of the two subscales).
  • 6. Skin Samples [ Time Frame: week0+72-120 hours and week 12+72-120 hours ]
    Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the skin of patients will be evaluated before and after dupilumab.
  • 7. Blood Samples [ Time Frame: week 0, week0+72-120 hours, week 12 and week 12+72-120 hours ]
    Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the blood of patients will be evaluated before and after dupilumab.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. At least 18 years of age

2. 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).

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

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

5. Documented recent history (within 6 months of patch testing) of inadequate response to
treatment with topical medications and allergen avoidance

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

Exclusion Criteria:

1. Prior dupilumab use

2. 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.

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 the
patient's prior patch testing, whichever is longer.

4. 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.

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

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

7. 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)

8. 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.

9. 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.

10. 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

Contacts and Locations
Contacts

Contact: Liset Chacin, BA 617-264-5926 lchacin@bwh.harvard.edu

Locations

United States, Massachusetts
Brigham and Women's Hospital, Department of Dermatology
Boston

Sponsors and Collaborators

Brigham and Women's Hospital

Regeneron Pharmaceuticals

More Information
  • Responsible Party: Brigham and Women's Hospital
  • ClinicalTrials.gov Identifier: NCT03935971 History of Changes
  • Other Study ID Numbers: 2018P002882
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: March 18, 2020
  • Last Verified: March 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Dermatitis
    Dermatitis, Contact
    Dermatitis, Allergic Contact