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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Allergic Contact Dermatitis | Experimental | Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | See arm/group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Eczema Area and Severity Index (EASI) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital, Department of Dermatology | Boston | Massachusetts | 02115 | United States |
6 of the 17 subjects enrolled were found ineligible due to not having a strong enough patch test reaction at visit 3
Our IRB protocol was approved to enroll 30 participants but only 17 were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Allergic Contact Dermatitis | Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Dupilumab: See arm/group description |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
IGA of at least 3 at baseline and at least one 2+ (strong) or 3+ (extreme) reaction on patch testing to participate in this open-label pilot study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Allergic Contact Dermatitis | Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Dupilumab: See arm/group description |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mean IGA scores | week 0, week 6, week 12 |
|
|
Through study completion, 12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Allergic Contact Dermatitis | Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Dupilumab: See arm/group description |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BWH Dermatology Research Project Coordinator | Brigham and Women's Hospital | 617-264-5696 | lchacin@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2023 | Dec 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2025 | Dec 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 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. | Not Posted | week 0, week 6, week 12 | Participants |
| 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). | Not Posted | week 0, week 6, week 12 | Participants |
| 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. | Not Posted | week 0, week 6, week 12 | Participants |
| 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. | Not Posted | week 0, week 6, week 12 | Participants |
| 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). | Not Posted | week 0, week 6, week 12 | Participants |
| Secondary | Skin Samples | Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the skin of patients will be evaluated before and after dupilumab. | Not Posted | week0+72-120 hours and week 12+72-120 hours | Participants |
| Secondary | Blood Samples | Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the blood of patients will be evaluated before and after dupilumab. | Not Posted | week 0, week0+72-120 hours, week 12 and week 12+72-120 hours | Participants |
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |