The Effects of Dupilumab on Allergic Contact Dermatitis

Allergic Contact Dermatitis Clinical Trial

Official title:

The Effects of Dupilumab on Allergic Contact Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935971
• Other study ID #: 2018P002882
• Status: Recruiting
• Phase: Phase 4
• Start date: December 18, 2019
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Brigham and Women's Hospital
• Contact: Liset Chacin, BA
• Phone: 617-264-5926
• Email: lchacin[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Drug:
• Dupilumab
See arm/group description

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital, Department of Dermatology	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change 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	Change in Body Surface Area (BSA)	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.	week 0, week 6, week 12
Secondary	Change in Eczema Area and Severity Index (EASI) score	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).	week 0, week 6, week 12
Secondary	Change in Numerical Rating Scale (NRS) itch	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.	week 0, week 6, week 12
Secondary	Change in Dermatology Life Quality Index (DLQI)	The Dermatology Life Quality Index is a 10-question, patient-reported instrument to assess impact of skin diseases on patient quality of life.	week 0, week 6, week 12
Secondary	Change in SLEEPY-Q (Sleep Questionnaire) score	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).	week 0, week 6, week 12
Secondary	Skin Samples	Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the skin of patients will be evaluated before and after dupilumab.	week0+72-120 hours and week 12+72-120 hours
Secondary	Blood Samples	Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the blood of patients will be evaluated before and after dupilumab.	week 0, week0+72-120 hours, week 12 and week 12+72-120 hours