Clinical trial NCT03935971: The Effects of Dupilumab on Allergic Contact Dermatitis
Official title: The Effects of Dupilumab on Allergic Contact Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Allergic Contact Dermatitis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2019-05-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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 18 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
11. Resident outside of Massachusetts, Connecticut, Rhode Island, New Hampshire, Maine or Vermont state.
12. Unable to use Zoom videoconferencing.

Primary outcomes:
measure: Change in Investigator's Global Assessment (IGA) score
timeFrame: week 0, week 6, week 12
Secondary outcomes:
measure: Change in Body Surface Area (BSA)
timeFrame: week 0, week 6, week 12
measure: Change in Eczema Area and Severity Index (EASI) score
timeFrame: week 0, week 6, week 12
measure: Change in Numerical Rating Scale (NRS) itch
timeFrame: week 0, week 6, week 12
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: week 0, week 6, week 12
measure: Change in SLEEPY-Q (Sleep Questionnaire) score
timeFrame: week 0, week 6, week 12
measure: Skin Samples
timeFrame: week0+72-120 hours and week 12+72-120 hours
measure: Blood Samples
timeFrame: week 0, week0+72-120 hours, week 12 and week 12+72-120 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital, Department of Dermatology
state: Massachusetts
Study officials:
References: